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Procedural
Sedation 2021
Self-Study Module CE 1034
Updated
3/2021
2
Clinical Education
Contact Laurie Mason MSN, RN, CNOR [email protected]
Phone (505) 272-0272
The information contained in this module is maintained and reviewd routinely by educators in
the Department of Clinical Education. Efforts were made to present the following content in an
accurate, clear, and concise manner while maintaining compliance with acceptable standards of
care. Your comments and concerns are important to us. Please do not hesitate to provide
feedback or identify errors, omissions or deficiencies in the content or presentation of this
important subject matter.
UPDATED: Laurie Mason MSN, RN, CNOR (1/2021)
REVISED AND UPDATED: Laurie Mason MSN, RN, CNOR (12/2015, 2017)
Angela Sanchez BSN, RN, PCCN Elizabeth Nuanez BSN,RN, CCRN
Updated: Kathy Willet, RN (5/2011)
Kim Atencio-Valentine, BSN, RN, CPAN (2010)
Della Daniel, RN, CNOR (2007)
Original: Wanda Pritts, MSN, RN (2002)
Module Developed by: Clinical Educators
University Hospital
For additional information regarding classes offered by Clinical Education, click on the
Education Website, Clinical Education:
http://hyper.unm.edu/edcs/educationhome.shtml or
Call 272-6313 for information about Clinical Education classes.
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Please READ!!!!
Directions for Completing this
Self-Study Module
Take the TEST for this self-study module ONLINE in Learning Central
(CE 1034). The test is an OPEN-BOOK exam to validate learning. Any
and all materials relevant to the exam may be present and referred to
while the test is being taken. The passing grade for the test is 84%.
When you pass the test, a learning event is recorded in your Learning
History. If you do not pass, you may try again. If you are unsuccessful
contact your educator for remediation and retesting.
This module is the required prerequisite for the Procedural Sedation
class and much of this material will be referred to during the course of
the class. You may print this material for review prior to scheduled
class.
COPYRIGHT 2015 UNIVERSITY OF NEW MEXICO ALL RIGHTS RESERVED. THE REPRODUCTION OR USE OF THIS DOCUMENT, IN PART OR IN WHOLE, IS FORBIDDEN WITHOUT THE EXPRESSED WRITTEN PERMISSION OF UNM
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PURPOSE
This module is an introduction to the core principles of procedural sedation and
analgesia. The information provided will assist you to plan and administer safe
sedation and analgesia. The nature of the procedure, the patient’s health status,
the patient’s ability to cooperate, and current medications should be considered
to develop a plan that meets each patient’s needs.
The information is organized into three main sections and includes information
pertinent to both the adult and the pediatric patient:
Pre-sedation Phase includes procedural sedation and analgesia fundamentals, and
assessment for appropriate patient selection;
Intra procedural Phase includes patient assessments, monitoring, management of
complications, and drugs used for sedation and analgesia;
Post Sedation Phase emphasizes patient assessment, monitoring, patient education,
and appropriate conditions for discharge.
The contents of this module are to be considered the minimum knowledge base for procedural sedation practitioners who are not anesthesia professionals.
THE INFORMATION PRESENTED IN THIS DOCUMENT IS NOT INTENDED TO REPLACE
CLINICAL JUDGEMENT
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DIRECTIONS
In order to receive privileges to administer procedural sedation at the University
of New Mexico Hospitals (UNMH), a passing score on a closed book, written test
that includes the information in this module and UNMH’s Policies and Procedures
that pertain to the administration of procedural sedation and analgesia (PSA) is
required. Use this module as a study guide to prepare for the test. Annual
competency validation is required to retain sedation privileges.
Testing can be accomplished by attending the Procedural sedation class or if you
have experience from somewhere else but have not shown competency at
UNMH, you may make arrangements for the Procedural Sedation Challenge exam.
This exam is given by appointment only in the Department of Clinical Education,
located at 1650 University NE, suite 1400. Nurses and Specialty Respiratory
Therapists are eligible for taking either the class or the challenge exam. Contact
the instructor for making arrangement to test out. Otherwise, register in learning
central for a convenient class time.
In order to be eligible for the Challenge exam, you must successfully complete this
SSM, then schedule the Challenge exam.
RNs and Specialty Respiratory therapists: Contact Laurie Mason, 272-0272
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OBJECTIVES
The learner will be able to: 1. Describe the four levels of sedation on the anesthesia continuum.
2. Understand UNMH policy regarding your role in administering procedural sedation
medications and monitoring patients.
3. Understand the Board of Nursing stance on the use of “anesthetic” medications in the
delivery of nurse provided procedural sedation.
4. Understand the American Society of Anesthesiology (ASA) patient classifications.
5. Understand the care for the patient during pre-procedure, intra-procedure, and post-
procedure phases of sedation.
6. Describe signs and symptoms of partial or complete airway obstruction.
7. Identify interventions to correct partial or complete airway obstruction.
8. Recognize the drugs, routes, and dosages for the drugs commonly used in sedation.
9. Identify side effects and contraindications to medications that have the potential to
suppress respirations and protective reflexes of the patient.
10. Integrate age-specific principles into care of the pediatric and geriatric patient undergoing
procedural sedation.
11. Identify elements of correct documentation of procedural sedation in both the paper based
record and the electronic version.
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INTRODUCTION
Procedural sedation, also known as moderate or conscious sedation or procedural
sedation and analgesia (PSA), is a drug induced state of reduced consciousness that allows the
patient to tolerate invasive procedures while independently maintaining a patent airway and
protective reflexes. The patient is able to respond to verbal commands or light tactile
stimulation, will have a protected airway, and maintain cardiovascular function. Sedation
administration occurs in a variety of settings such as GI suites, clinics, ERs, patient rooms and
treatment areas, by non-anesthesiologist trained professionals to patients of any age. This type
of sedation is used for any procedure in which a patient’s pain or anxiety may be excessive and
may impede performance.
There are no absolute indications for procedural sedation. The clinician and the patient
must agree that the potential benefit of the sedation outweigh the risks. Procedural sedation
does not include patients receiving sedatives or analgesics for other reasons, such as post-
operative pain management or Rapid Sequence Intubation. In addition, patients who are
mechanically ventilated or receiving nitrous oxide are not included in the guidelines that
pertain to procedural sedation.
The New Mexico Board of Nursing (NM BON) defines procedural sedation as “a
technique of administering sedatives or dissociative agents with or without analgesics to
induce a state that allows the patient to tolerate unpleasant procedures while maintaining
cardio respiratory functions.”
Regulations and Practice Guidelines
Since 1985, many professional organizations have issued practice guidelines and
standards for procedural sedation, including the American Academy of Pediatrics (AAP), the
American College of Emergency Physicians (ACEP), the American Nurses Association (ANA),
Association of Operating Room Nurses (AORN), and the American Society of Anesthesiologist
(ASA). Practice guidelines and standards promote patient safety by standardizing clinical
practice, but they are suggestions and are not mandatory.
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The Nurse Practice Act (http://nmbon.sks.com/Statute.aspx) defines the scope of
practice for registered nurses in each state and is legally binding. Each nurse should be aware of
what their scope of practice is. Additional standards from The Centers for Medicare and
Medicaid Services (CMS) and The Joint Commission (TJC) are mandatory for participating
organizations.
The sedation continuum describes a range of states beginning with minimal sedation and
ending with general anesthesia. Each stage of sedation has been defined by the American Society of
https://www.ebmedicine.net/topics.php?paction=showTopicSeg&topic_id=134&seg_id=2673
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Anesthesiologists (ASA) in terms of level of consciousness, airway, spontaneous ventilation and
cardiovascular function (ASA, 2009). The goal of Procedural sedation is for the patient to be able to
cooperate and tolerate unpleasant procedures and maintain their airway and cardiovascular
function as described by moderate sedation/analgesia on the continuum. Dissociative sedation has
not previously been a state on the sedation continuum, but table 1 illustrates Ketamine’s role in the
sedation continuum quite well. This altered level of consciousness is associated with ketamine’s
distinct action. Ketamine causes a trance-like state providing the patient with profound sedation and
analgesia; cardiopulmonary systems are stable and protective reflexes remain intact.
The sedation continuum has been accepted and applied by clinicians through all specialties and
is used by CMS and TJC to define the appropriate expertise of the clinician providing sedation. It is the
expectation of CMS and TJC that the Procedural sedation practitioners have the knowledge and skills to
manage a patient’s care at the next deeper level of sedation. This skill level is referred to as the ability
to rescue. To safely administer procedural sedation, the individual administering procedural sedation
must be able to monitor and maintain patients at the desired level of sedation, and must be able to
rescue those patients who unavoidably or unintentionally slip into a deeper than targeted level of
sedation, (TJC, 2011).
Procedural Sedation Competance
RNs & Specialty RTs
Table 2 UNMH Policy(2011) & University Health Consortium(2005) PSA Best Practice Recommendations
(Procedural sedation and analgesia)
Recommendation Specific Criteria
Type of PSA allowed to administer Moderate PSA ONLY Initial competence demonstrated by Completion of the SSM and Attendance of Procedural Sedation Course once
or completion of the SSM and passing score on challenge exam Renewal of privileges Passing score on Procedural Sedation on-line competency annually.
Annual observed skill validation either on unit or in Batcave.
Regular review of patient outcomes for those patients who the practitioner administered moderate PSA.
Resuscitation Competence BLS & ALS appropriate to patient populaion.
Systems Assessment Verify ASA and H&P (within 30 days) documented by provider. Cardiopulmonary Assessment completed and documented prior to procedure. Appropriate focused assessment completed and documented prior to procedure.
Airway Assessment & Management Competence
Ability to examine the airway, recognize high-risk airways, verify Mallampati classification, recognize airway obstruction, insert oral/nasal airways, perform jaw thrust, use bag-valve-mask, operate oxygen cylinder & flow meter, and operate suction regulator & suction the patient.
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Cardiac Monitoring Competence Basic Cardiac Arrhythmmia Course once or passing score on challenge exam. Maintain annual arrythmia competency.
Pharmacology Competence Procedural sedation course with a passing score on the exam. Each area may require unit-specific pharmacology SSM.
Facility Policy Competence Facility Sedation Policies & Procedures competence with a passing score on the annual online competency exam.
Physicians
Table 3 UNMH Policy & University Health Consortium PSA Best Practice Recommendations (These guidelines
are currently under revision and NOT available for this updated module)
Recommendation Specific Criteria for MODERATE PSA Specific Criteria for DEEP PSA
Administered by Physicians
NP’s
Residents with supervision
Residents independently IF the situation is an emergency, House Officer II or above, & documented competence in a minimum of 5 cases
Attending Physicians ONLY
Initial competence demonstrated by
Passing score on written exam (offered in BAT CAVE)
Successful completion of Advanced Procedural Sedation Course once
Renewal of privileges Passing score on age appropriate written exam every two years (offered in BAT CAVE)
Completion of at least 10 moderate PSA procedures within previous 2 years.
Regular review of patient outcomes for those patients who the practitioner administered PSA.
Resuscitation Competence Enhanced BLS (with airway management)
ALS appropriate to patient population HIGHLY RECOMMENDED.
ALS appropriate to patient population
Airway Assessment & Management Competence
Ability to examine the airway, recognize high-risk airways, perform Mallampati classification, recognize airway obstruction, insert oral/nasal airways, perform jaw thrust, use bag-valve-mask, operate oxygen cylinder & flow meter, and operate suction regulator & suction the patient.
Ability to use advanced airway adjuncts
(LMA & ETT)
Difficult Airway Management Course
Rapid Sequence Intubation Course
Cardiac Monitoring Competence Ability to recognize cardiac rhythm disturbance and intervene appropriately
Vascular access management skills (Central Venous Access) & ability to manage the care for patient with cardiovascular instability
Pharmacology Competence Pharmacology course with a passing score on a written exam.
Facility Policy Competence Facility Sedation Policies & Procedures competence with a passing score on a written exam.
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RNs and Specialty RTs can be verified as meeting initial procedural sedation competance in
Learning Central after completing the course and associated test or completing the challenge exam.
Physicians can be verified on the UNMH Intranet home page by going into the UNMH Practitioner
Privileges tab.
Goals of Sedation
Anxiolysis
Amnesia
Analgesia
Muscle relaxation
Control behavior or movement
Definitions
Analgesia-Relief of pain without intentionally producing a sedated state. Altered mental status may occur as a secondary effect of medications administered for analgesia.
Anxiolytic-an antianxiety medication to relieve apprehension, fear or agitation
Amnesia-partial or total loss of memory related to the medication given
Anesthetics, means a drug-induced loss of consciousness, otherwise known as general anesthesia, during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory support is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. General anesthesia is used for those procedures when loss of consciousness is required for the safe and effective delivery of surgical services. (BON)
Procedural sedation, a technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardio respiratory functions. (BON)
Capnography-a real time measurement of the patient’s exhaled CO2. It provides a better indication of how well the patient is oxygenated
Hypoxia/ Hypoxemia-abnormally low level of oxygen in the blood
Laryngospasm is a brief spasm of the vocal cords that temporarily makes it difficult to speak or breathe. The onset of vocal cord spasms is usually sudden, and the breathing difficulty can be alarming. However, the problem is not life-threatening, and it's generally brief and self-correcting.
Bronchospasm is an abnormal contraction of the smooth muscle of the bronchi, resulting in an acute narrowing and obstruction of the respiratory airway. A cough with generalized wheezing usually indicates this condition. Bronchospasm is a chief characteristic of asthma and bronchitis.
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Phases of Sedation
The pre-sedation phase of PSA includes a pre-sedation risk assessment, determination
of the patient’s suitability for PSA, the development of sedation plan, patient and family
education, informed consent and confirmation that all of the information and equipment to
complete the procedure are in place. An up to date history and physical should precede the
pre-sedation phase, and be in the medical record. The sedation phase includes the process of
the medication and monitoring of the patient during a sedation case, while the third phase is
the post sedation or recovery phase.
Pre-Procedural Phase
Pre-Sedation Risk Assessment
A collaborative patient assessment for sedation is essential for safe and effective care. Both
the physician and the nurse have a role in patient selection and preparation for procedural sedation. It
is mandatory that certain key elements of the pre-sedation risk assessment and patient interaction be
documented before sedation is given, even if a full dictated note is to follow. These include:
Evidence of patient’s suitability to receive PSA
Evidence of informed consent via a sedation consent which is signed by the physician and
patient and witnessed appropriately.
The sedation plan
Re-evaluation of the patient immediately prior to sedation administration
The combination of patient and provider characteristics, procedural factors, and medication
properties all factor into the successful development of an individualized sedation plan designed to
maximize comfort and minimize risk. In order to minimize risk and increase the likelihood of achieving
desired outcomes, the providers must appreciate all aspects of the sedation experience associated
with the patient, the procedure, and the provider of sedation.
The Patient
While PSA is generally safe, it is not without risk to the patient. The risks can be minimized by a
thorough pre-sedation assessment of the patient’s physical condition and medical history, as well as
the patient’s attitude and expectations about having a procedure using PSA. PSA practitioners must be
familiar with the patient’s medical history and current condition, and how these might affect the
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patient’s response to PSA. The information gathered is then used to develop an individualized
sedation plan, and helps the practitioner predict how the patient might respond to the procedure and
the medications. Each patient is at risk for complications and therefore, appropriate patient selection
cannot be overemphasized. Remember, every patient is unique and should not be compared to others
of like history.
Medical History
The medical history includes ascertaining current comorbidities and recent acute illnesses;
sedation/anesthesia history of the patient and the family with focus on complications and airway
problems; allergies and sensitivities; current medications; the time and nature of last oral intake;
history of tobacco, alcohol, or substance use or abuse; and functional status.
Comorbidities and Recent Acute Illnesses
The patient’s chronic medical problems and recent acute illnesses can significantly affect their
ability to tolerate a procedure and their response to PSA medications. Any condition that alters
perfusion may affect how medications are absorbed, distributed, metabolized, and excreted by the
patient’s body. The following table summarizes treatment considerations with certain comorbidities.
TABLE 3 SUMMARY OF COMORBID CONDITIONS
Comorbidity Concerns Treatment Considerations
Airway/Respiratory Disease Asthma
COPD
Obstructive Sleep Apnea
Upper Respiratory Infection
Enlarged tonsils
Airway/Respiratory Disease continued
Maxillofacial surgery
TMJ
Smoking
PSA medications decrease respiratory drive & rate
Blunting of hypoxic drive in CO2 retainers may lead to respiratory failure r/t sedation & medications
Recent URI may lead to increased airway irritability
Limited ROM to jaw or neck may interfere with emergency airway interventions
Does the patient have intact protective reflexes?
Does patient use oxygen at home?
Can patient tolerate position of procedure?
Have patient bring rescue inhaler to procedure room & take a dose prior to PSA
Apply oxygen unless blunting of hypoxic drive is a realistic concern
Have patient bring CPAP or BiPAP & use it during the procedure
Caution with medications that cause histamine release
Consult Anesthesia
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Body Habitus
Obesity (O) BMI over 30
Underweight (U) BMI less than 18.5
Increased oxygen consumption (O)
Decreased Functional Residual Capacity (O)
Redundant airway tissue
Fatty liver (O)
Gastro esophageal Reflux (O) Aspiration risk
Impaired drug metabolism = Increased & prolonged drug effects (O&U)
Low albumin = Increased sensitivity to drugs
Increased risk of infection (U)
Can patient tolerate the position of the procedure?
Apply oxygen during PSA (O & U)
Increased risk of airway complications (O)
Increased risk of hypoxemia (O)
Consider H2 antagonist pretreatment (O)
Semi-sitting position to reduce pressure on diaphragm (O)
Consider reducing initial dose of PSA medications (U) Assess patient response to initial dose to determine amount of next dose
Cardiovascular Disease Ischemic disease
Heart failure
Significant dysrhythmias
Severe valvular disease
Hypertension
Heart Failure
Hyper sympathetic state puts patients at risk for symptoms during PSA
Myocardial oxygen supply – demand
Low ejection fraction = Slower distribution time of medication
Renal insufficiency = Prolonged effect of medication
Can patient tolerate position of procedure?
Apply oxygen during PSA
Continue antianginal, antidysrhythmics and antihypertensives
Consider reducing initial dose of PSA medications Assess patient response to initial dose to determine amount of next dose
Consider doubling the interval between titrated doses of PSA medications
Be aware of fluid and electrolyte status
Avoid excess IV fluids
Endocrine Disease Diabetes
Thyroid Dysfunction
Likely to have end-organ damage: Cardiac, Renal, Neurological
Joint collagen tissue abnormalities (limitation in neck extension
Hypoglycemia or Hyperglycemia
Prolonged gastric emptying Aspiration risk
Increased susceptibility to infection
Impaired drug metabolism = Increased & prolonged drug effects
Check blood glucose before, during, and after the procedure
Oral hypoglycemic medications should be stopped the day before the procedure
Long acting insulin e.g., Lantus should NOT be stopped before the procedure
Continue thyroid replacement or anti-thyroid medications
Gastrointestinal Disease Liver Disease
Liver disease = Impaired drug metabolism
Increased & prolonged drug effects
Consider reducing initial dose of PSA medications Assess patient response to
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Reflux, Heartburn
Coagulopathies related to liver disease
Low albumin = Increased sensitivity to drugs
Increased risk for aspiration with GERD, nausea & vomiting
Can the patient tolerate the position of the procedure?
initial dose to determine amount of next dose
Consider doubling the interval between titrated doses of PSA medications
Consider expected procedural blood loss or vascularity of procedural site
Consider pretreatment of reflux with H2 Blocker or non-particulate antacid (Bicitra)
Infectious Disease Hepatitis, HIV, MRSA, VRE
Evaluate end-organ disease
Many drug interactions between PSA drugs anti-retrovirals & antibiotics
Ensure appropriate transmission-based precautions are initiated & communicated
Mental Health Disorders Many drug interactions between PSA drugs and antidepressants, antipsychotics.
Fear & anxiety increase catecholamine release
Can patient cooperate during the procedure?
Titrate drugs appropriately—easy to over sedate anxious patient in an effort to alleviate symptoms quickly.
Develop a system to communicate prior to the procedure.
Neurological Disease Involvement of respiratory muscles or brain stem?
Seizures
Decreased vascular tone
Many drug interactions between PSA drugs and antiepileptic’s
If decreased respiratory muscle strength:
Consult Anesthesia
Neuromuscular Disease Amyotrophic lateral sclerosis (ALS), Multiple sclerosis, Myasthenia gravis, Spinal muscular atrophy
Loss of muscle tone
Decreased respiratory muscle strength
May need assessment of respiratory muscle strength
Consider non-invasive positive pressure ventilation for decreased O2 saturation
Consider Anesthesia Consult
Pregnancy/Lactation Increased airway edema = Difficult intubation
Loss of pulmonary reserve
Prolonged gastric emptying & decreased esophageal sphincter tone Aspiration risk
Consider fetal effects of medications
Consider presence of medication in breast milk
Apply oxygen during PSA
Lateral positioning to prevent aorto-caval compression
Consider non-particulate antacid (Bicitra) & metoclopramide (Reglan)
Instruct lactating patient to “pump & dump” or expect infant to demonstrate medication effects
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Renal Disease Renal Insufficiency
Renal Failure
Dialysis
Renal disease = Impaired drug elimination
Prolonged drug effects
Fluid & electrolyte imbalance
Last dialysis?
Consider reducing initial dose of PSA medications by half
Assess patient response to initial dose to determine amount of next dose
Be aware of fluid and electrolyte status
Avoid excess IV fluids
Be aware of vascular access device for dialysis
In the following situations, the sedation nurse MUST consult a provider who is privileged in
moderate or deep sedation or an Anesthesia Provider prior to sedating patient:
Patient does not fulfill NPO criteria and requires emergency diagnostic exam or procedure
Severe cardiopulmonary, neurological or other organ system disease, which may present a significant hazard with administration of sedation
Potential difficult airway management (congenital airway disorders, obstructive sleep apnea (OSA), morbid obesity, spinal immobilization)
Patient taking meds that could adversely react with sedatives or analgesics (MAO inhibitors)
Prior history of adverse reaction to sedation or anesthesia.
Sedation and Anesthesia History
The previous experiences of the patient to be sedated should be explored. Both good and bad
experiences should be reviewed along with the drugs that were previously administered if known.
Patients that have had difficulties with sedation or anesthesia in the past are more likely to have
problems in the future. Specifically address airway and breathing issues, such as a previous difficult
intubation or breathing problems; severe nausea and vomiting; prolonged drowsiness; paradoxical
reactions to medications; and anxiety.
Also inquire about blood relatives to assess for inherited disorders such as malignant
hyperthermia or pseudo cholinesterase deficiency, (Roberts & Hedges, 2010). In the scope or
procedural sedation, the drugs that could cause malignant hyperthermia would not be given. These
drugs include succinylcholine and volatile anesthetic gases such as Desflurane, Isoflurane, sevoflurane
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and Ether. In pseudo cholinesterase deficiency, these patients may have an increased sensitivity to the
local anesthetic procaine which could possibly be used during a sedation case.
Allergies and Sensitivities
It is necessary to inquire about allergies to food, drugs, and substances such as latex or
radiographic dye, including the specifics of the patient’s response to the exposure. Patients may
report an allergy to a substance when the reaction was a common, expected side effect such as
nausea and vomiting. Allergies to food, such as eggs, soy, and shellfish are very relevant since
propofol contains egg and soy products, and there is a known cross-sensitivity between IV contrast
dye and shellfish.
Current Medications
Obtain a list of the patient’s current prescription medication, over-the-counter medications,
herbal & homeopathic remedies, the dosage and time last taken. There are many interactions
between herbs and PSA medications. Herbal supplements can interact with conventional medicines
or have strong effects. Use an online drug interaction tool such as Lexicomp to check all of the
patient’s current medications and ordered PSA medications for drug interactions.
Substance Abuse
The pre-sedation risk assessment provides an opportunity to obtain a history of addiction and
recovery. Addictive disease is considered permanent, even in patients who have had long periods of
abstinence. If a patient is in recovery, knowledge of the dosages and effects of medications used for
maintenance of recovery is essential. During the post-procedural phase, anxiety may be increased due
to concern about the possibility of both relapse and inadequate pain management because of the
history of addiction. Inadequate analgesia can potentially lead to relapse. The patient should be
assured during the pre-sedation assessment that anxiety and pain will be adequately treated. PSA
practitioners may have biases regarding addiction and may lack the knowledge to develop an
appropriate plan for PSA for these patients. Identifying these at-risk patients during the pre-sedation
phase and involving the acute pain service to assist in management may be helpful. All information
and potential management plans should be clearly communicated to all members of the PSA team.
Chronic use of alcohol, narcotics, and other drugs results in a permanent induction of liver
enzymes used in the metabolism of these drugs causing it to metabolize drugs faster resulting in
decreased effectiveness and the need for higher than usual doses, (Roberts & Hedges, 2010).
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Alcohol
It is important to know how much alcohol is being used, the amount of time since the last
intake, and the degree of end-organ involvement related to alcohol intake. Depending on the
characteristics of alcohol use and the degree of end-organ damage related to alcohol, PSA
medications may require an increase or decrease in usual dosing strategies.
Alcohol and PSA meds will act synergistically causing increased sedation if both are actively
circulating. Chronic, daily intake of alcohol will likely cause decreased effectiveness of PSA
medications requiring higher doses to achieve the desired effect. Patients with liver cirrhosis will likely
have an increased response to PSA medications requiring the dose to be decreased and given less
frequently.
Alcohol has extensive direct physiologic effects on end-organ function. Cardiomyopathy is the
most common cardiac occurrence; anemia, malnutrition, and ulcerative gastrointestinal disease also
occur. Esophageal reflux predisposes the alcoholic patient to aspiration. In late stages of alcoholism,
esophageal varices may occur predisposing the patient to acute hemorrhage during the placement of
artificial airways or nasogastric tubes. Liver cells are destroyed each time alcohol is ingested. Although
liver cells regenerate, eventually they become sclerosed and cirrhotic resulting in the loss of hepatic
functions, such as coagulation and drug metabolism.
In cirrhosis, altered drug metabolism occurs for several reasons. First, reduced blood flow
through the cirrhotic liver slows the metabolism of drugs. Reduced protein synthesis (albumin) leads
to inadequate protein-binding sites for drugs; so much of the drug that was administered remains
unbound and active in circulation.
Drugs
Chronic use of opiates, benzodiazepines and illegal drugs may cause the patient to require
higher than usual doses of PSA medications due to altered drug metabolism as described above. IV
drug abuse is often accompanied by end-organ dysfunction and infections.
Cocaine and amphetamines increase BP, raise HR, and can lead to coronary artery vasospasm
and thrombosis even in patents without coronary artery disease. These drugs cause release of
norepinephrine, epinephrine, and dopamine and block their reuptake. Taken chronically, they deplete
nerve endings of these neurotransmitters. Depletion of transmitters in sympathetic nerve endings
renders drugs such as ephedrine ineffective because these drugs act primarily by releasing
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catecholamines. The cardiovascular side effects of cocaine are increased with the administration of
beta-blockers.
Anabolic steroids suppress the natural cortisone production in the adrenal cortex, leading to
the inability to demonstrate an adequate response to stress. Consideration should be given to
providing intravenous steroid coverage prior to PSA.
Tobacco
Respiratory changes associated with smoking include early closure of small airways, paralysis
of cilia, chronic increase in secretions, and the eventual destruction of lung tissue. Vital capacity and
functional reserve are reduced and oxygenation of the body tissues is compromised.
Chronic smoking results in approximately 10% reduction in functional hemoglobin
concentration. The carbon monoxide in cigarette smoke attaches to hemoglobin, producing
carboxyhemoglobin, freeing up hemoglobin to oxygenate tissues. Smoking cessation for that short
time will not reverse the other harmful effects of smoking such as increased secretions, ciliary
paralysis, and irritation of the tracheobronchial tree. Patients who smoke may exhibit spasmodic
coughing, increased secretions, and are at a higher risk for developing hypoxemia, bronchospasm, and
laryngospasm during PSA.
NPO Status
A history of last oral intake is required before providing sedation. Although there are no
standard guidelines for fasting prior to PSA, most experts advise fasting guidelines that mimic those
required for anesthesia. Both the AAP (American Academy of Pediatrics) and the ASA
(American Society of Anesthesiologists) have issued recommendations for nothing by mouth (NPO)
prior to elective procedures with anesthesia. The recommendations are based on expert opinion and
are not evidence based. Meta-analysis of general anesthesia data shows that the risk for aspiration is
low. Several studies have tried to address NPO status for emergency department patients undergoing
PSA; no conclusions can be drawn other than adverse events are low regardless of NPO status, and
risk is more related to the depth of sedation, (Godwin, Caro, & Wolf, 2005).
The rationale for these recommendations is it is difficult to predict the exact depth of sedation
that will result from PSA medications, therefore it should be assumed that airway reflexes may be lost
and aspiration secondary to delayed gastric emptying may occur.
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The potential for aspiration of gastric contents must be considered when determining the
targeted level of sedation, and whether the procedure should be delayed, or if the patient requires a
protected airway (endotracheal intubation).
TABLE 4 PREPROCEDURE FASTING GUIDELINES
Substance
Minimum Fasting Period
Clear Liquids 2 hours
Breast Milk 4 hours
Infant Formula & Non-human Milk or Light meal
6 hours
Solid Foods 6 hours
Full Meal, Fatty meal, or Enteral Feeding* 8 hours
Gastric emptying is influenced by many factors, including anxiety, pain, comorbidities, and medications. Therefore, following a fasting protocol does not guarantee that complete gastric emptying has occurred.
*Enteral formulas are considered to be a fatty meal. If judged appropriate by treating practitioner, patients who have had a xray confirming proper placement, the tube is properly secured and/or critically ill patients with a cuffed mechanical airway may receive enteral feeding up to the time of the sedation.
Pre-sedation Diagnostic Testing
No routine laboratory or diagnostic screening tests are required, but may be indicated based
on health status, past medical history, and medication. Females with the ability to become pregnant
should have a urine HCG performed prior to the procedure. Diabetic patients should have a capillary
blood glucose performed prior to the procedure. See Appendix
Pre-Sedation Physical Exam
The pre-sedation physical exam should include:
Weight in kilograms, baseline vital signs including ETCO2
Respiratory and cardiovascular status, which includes auscultation of the heart and lungs. This
includes ensuring that a Mallampati score has been assessed and documented by the LIP.
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ASA physical status classification score as illustrated in Table 1. This is assigned by the LIP, but
should also be verified by the sedation nurse.
Brief neurological examination to determine cognitive ability, emotions status, and baseline
level of consciousness.
Focused physical Assessment as appropriate with baseline Aldrete score
Heart rate, blood pressure, respiratory rate, oxygen saturation and temperature
Baseline assessment of pain, including pain scale used
Verify patient has a working IV appropriate for the sedation need
American Society of Anesthesiology (ASA) Classification Score
To aid in assessment of sedation risk, the ASA has developed a classification system for
patients, which categorizes individuals on the basis of general health prior to receiving general
anesthesia (see Table 5). This score predicts the possibility of adverse events. All patients to receive
PSA must have an ASA score assigned. This is an LIP responsibility and must be documented on
the Procedural Sedation Record. Ideal candidates for PSA are ASA Class I or II. Class III patients can
have nurse administered PSA, but consultation with an anesthesia professional should be considered.
ASA IV or V patients are not candidates for nurse administered PSA. These patients are at an increased
risk for morbidity and mortality.
Table 5 ASA Classification Scale
Advanced Airway Exam
Advanced Airway Exam
ASA I—No organic, physiologic, biochemical, or psychiatric disturbance.
ASA II—A patient with mild systemic disease that results in no functional limitation. Examples are well-controlled hypertension and uncomplicated diabetes mellitus (no renal disease), Mild asthma, smoking without COPD, mild obesity, pregnancy
ASA III—A patient with severe systemic disease that results in functional impairment. Examples are diabetes mellitus with vascular complications, myocardial infarction less than 6 months ago, and uncontrolled hypertension, stable angina, old MI, controlled CHF, CRF, COPD, obesity
ASA IV—A patient with severe systemic disease that is a constant threat to life. Examples are congestive heart failure and unstable angina pectoris., end stage disease, CRF on dialysis, acute MI, resp failure requiring mech vent
ASA V—A moribund patient who is not expected to survive with or without the surgery. Examples are ruptured aortic aneurysm and intracranial hemorrhage with elevated ICP.
ASA VI—A declared brain-dead patient whose organs are being harvested for transplantation.
E—Emergency surgery is required. For example, ASA IE represents an otherwise healthy patient undergoing emergency appendectomy.
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Pre-procedural assessment of the upper airway is crucial. Most complications from PSA are related
to airway and breathing issues. The PSA practitioner should focus on finding any patient
characteristics that would make rescuing the airway difficult. Patients who have any of the points
outlined in the significant history below or who have an abnormal airway exam should be considered
at increased risk for airway complications during PSA. Also, they potentially have a difficult airway to
manage if mask ventilation, adjunct airway devices, or intubation becomes necessary. Significant
history that suggests increased risk during sedation:
History of difficult intubation, snoring, stridor, or sleep apnea
Short neck
Any limitations of head, neck, and jaw mobility (arthritis, TMJ, C-spine surgeries)
Neck mass
Obesity, especially involving the head, neck, and face
Current upper respiratory infection
Lung disease
Facial hair
Poor dentition or edentulous
Age over 55
TABLE 7 ABNORMAL AIRWAY EXAM
Small or recessed chin (look at patient’s profile)
Inability to open mouth normally
Limited or no visualization of the uvula or
tonsils with the mouth open wide and tongue
protruding (Mallampati Class III or IV)
High arched palate
Large tonsils
Limited range of motion to neck
TABLE 6 NORMAL AIRWAY EXAM
Opens mouth at least 3 fingers (The patient’s
fingers)
Able to visualize the uvula and tonsillar pillars with the mouth open wide and tongue protruding
(Mallampati Class I or II)
Chin length at least 3 fingers (3:3:2 Rule)
Normal neck flexion and extension without pain or parasthesias
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Mallampati Classification
The Mallampati score assesses the size of the tongue in relation to the oral cavity. The Mallampati
classification is performed by having the patient sit up, open the mouth widely and protrude the
tongue completely forward. A tongue depressor is not used.
1. Class 1: Entire tonsil clearly visible
2. Class 2: Upper half of tonsil fossa visible
3. Class 3: Soft and Hard Palate clearly visible
4. Class 4: Only Hard Palate visible
In general, a patient in whom the uvula, tonsillar pillars, and soft palate are visible (Class I) will be
easy to mask ventilate and intubate. Patients in whom only the hard palate is visible, a Class IV airway,
have a higher likelihood of being difficult to mask ventilate and intubate.
Sleep Disordered Breathing
Sleep apnea is a sleep disorder in which breathing is interrupted and characterized by loud snoring
and restless sleep. The most common symptoms are:
o Loud snoring o Restless sleep o Morning headaches o Sleepiness or lack of energy during day time o Waking up with dry mouth or sore throat o Irritability o Mood changes o Decreased interest in sex o Insomnia
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The most common causes for sleep apnea are being overweight (Higher BMI), having enlarged
tonsils and adenoids, especially in children, excessive alcohol consumption and smoking. A
sleep study called polysomnography can records brain waves, the oxygen level in the blood,
heart rate and breathing, as well as eye and leg movements during the study. Polysomnography
is usually done at a sleep disorders unit within a hospital or at a sleep center. The test records
nighttime sleep patterns.
Patients with a history of sleep apnea, snoring and stridor should be discussed with an
anesthesia provider since patients with OSA may be at increased risk for sedation-related
complications during sedation procedures. There are many assessment tools to use if OSA is
suspected. The STOP BANG tool and the STUBR tool being the two used I our facility.
STBUR Airway Risk Scale
Snoring, Trouble Breathing, Un-Refreshed (STBUR)
Validated Screening
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Snore more than half the time? 1=Yes 0=No
Snore loudly? 1=Yes 0=No
Trouble breathing or struggle to
breathe?
1=Yes 0=No
Ever stop breathing during the
night?
1=Yes 0=No
Wake up feeling un-refreshed? 1=Yes 0=No
Total Score=
max 5
1-2= low risk, 3-4= moderate risk, 5 is high risk. Greater than 3 requires an anesthesia consult
Procedural Considerations
When choosing a sedation medication, the PSA practitioner should consider the length of the
procedure and what is being done, if the procedure will be painful, and if immobilization is needed.
Sedatives that are commonly used for sedation, like the benzodiazepines, have absolutely no
analgesic effect. Analgesic medications such as fentanyl will provide pain control for the procedure
without the same degree of the sedating effect of benzodiazepines. Using drugs without analgesic
properties to manage pain can cause delirium and agitation, and an increased perception of pain.
Analgesic medications must be included if the procedure is going to be painful while they may be
omitted for non-painful procedures. Dissociative medications such as ketamine provide
immobilization and analgesia, and may be useful for brief painful procedures where immobilization is
needed.
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Position Required For the Procedure
While considering PSA, the provider must consider the position that the patient will be in
during the procedure, if the patient can tolerate it, and how difficult it will be to manage the patient’s
airway if needed. The average person will maintain an open airway in the supine position even when
sedated as long as the neck can be slightly extended. If the head must be flexed during a procedure
e.g., lumbar puncture, obstruction of the airway will be much more likely. In general, when people are
placed on their side or in a prone position the airway is at least as easy to maintain as when in the
supine position. If the visualizing the airway and breathing is going to be difficult such as in MRI, the
providers must take into account that adjustment of the airway will not be possible and assisting
ventilation will require stopping the procedure.
Final Patient Selection
After the pre-sedation history and physical assessment are complete, the PSA provider must
evaluate all of the patient information and decide if the patient is an appropriate candidate for PSA.
Some patients are not suitable candidates and require an anesthesia professional to manage their
care for a procedure.
Higher risk patients required airway intervention 20% of the time versus 2.6% in lower risk
patients. Specific high risk patient populations in which anesthesia consultation is highly
recommended or required have been identified by UHC, ASA, AAP, and other groups (University
Health Consortium, American Society of Anesthesiologists and American Academy of Pediatrics
respectively).
RECOMMENDED ANESTHESIA CONSULTATION
More than one significant comorbidity
Multiple drug allergies
Multiple medications with potential for drug interaction with PSA medications
Pregnancy
Known respiratory compromise
Obstructive sleep apnea
ASA greater than 3
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REQUIRED ANESTHESIA CONSULTATION
Infants born less 37 weeks gestation who are less than 60 weeks post conception and are not
residing in the neonatal intensive care unit of the pediatric intensive care unit (a pediatric
intensivist is an acceptable alternative to consultation with an anesthesiologist for pediatric patients)
History of airway compromise during PSA or anesthesia
History of adverse reaction to PSA or anesthesia
Patients with neuromuscular disease affecting respiratory or brain stem function
Abnormal advanced airway exam
Sedation Plan
TJC and CMS require that a plan for sedation be developed based on patient history and
physical assessment. The physician must develop and document the plan; the RN or Specialty RT must
be aware of the plan.
The plan should include the targeted level of sedation, the medications and dose to be used,
the specific, individualized risks to the patient, and the plan for post-procedure pain management and
patient disposition (inpatient or outpatient). The physician should also document the patient’s ASA
classification and Mallampati classification. The plan should then be discussed with the patient and
family.
Informed Consent
Informed consent is obtained by the physician prior to the procedure and prior to the patient
receiving PSA medications. The physician should review the sedation plan with the patient and family.
The conversation should include:
Potential risks and benefits
Potential problems after the procedure
Potential for PSA to fail
Consequences of not providing PSA
Alternatives to PSA
It is important to remember that obtaining informed consent is a process and not a form. It is
preferable to have the patient sign an official consent for the procedure and the PSA, but as long as
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there is documentation showing that the physician informed the patient of the above information and
the patient agrees to proceed, informed consent has been obtained.
Two forms, one for the procedure and one for the sedation can be found on the UNMH Intranet
under Clinical Forms: Consent for Surgery, Special Procedures, and Transfusions and Consent for
Conscious and /or Deep Procedural Sedation.
In the case of ongoing procedures such as wound care, the consent should list the frequency and
probable duration for the series of procedures. For example, “sharp debridement of wound and
dressing change on sacrum every other day from- this date to this date”. Obtain a new consent upon
expiration of older consent. If PSA is being performed for a procedure that does not require a consent,
such as a dressing change for burn care, the consent form titled, Consent IV Conscious and/or Deep
Procedural Sedation is used.
Patient and Family Education
By providing pre-sedation patient education, the PSA providers can calm patient and family fears
and anxiety regarding the planned procedure. Education should include:
The expected events surrounding PSA including IV access, the monitoring equipment, the
personnel who will be in the room, the expected length of procedure, and how pain and
anxiety will be managed.
An honest description of the amount of discomfort to be expected during the procedure even
with medications. It is unacceptable to describe moderate PSA as providing total pain relief
and amnesia; only deep PSA will provide total pain relief and amnesia because the patient is
unconscious.
Determine a method for the patient to communicate pain or anxiety with the PSA provider.
Explain what the patient will be asked to do during the procedure, such as deep breathe or
change position.
The recovery process and expected length of stay after the procedure. It is very important to
ascertain if the outpatient has transportation home and has a caregiver for at least 6 hours
post-procedure. The patient cannot drive and must be discharged with an adult who is willing
to chaperone the patient for at least 6 hours. Patients should not be sent home unattended.
Any expected activity or dietary restrictions.
The plan for follow up care.
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Equipment
Before undertaking PSA there are some key pieces of equipment that must be at the bedside
regardless of the targeted level of sedation. In the sedation cart or in each room where PSA is
administered, a bag-valve-mask (BVM), oxygen, appropriately sized oral and nasal airways, cardiac
monitor, suction, non-invasive blood pressure monitor, and a pulse oximeter should be at the
bedside. The use of end tidal carbon dioxide (ETCO2) monitoring is becoming more widely expected
and should be used if available, especially if the patient’s respirations are going to be difficult to
visualize or for deep PSA, (Green & Pershad, 2010).
Additionally, pediatric patients must have the pediatric code sheet present since all the
medications will be calculated based on the child’s weight in kilograms.
While pulse oximetry serves as a good measure of oxygenation, Capnography can provide a
more sensitive measure of ventilation. Apnea may not be detected by pulse oximetry alone until 30-
60 seconds after it occurs, but with Capnography, apnea can be detected almost immediately.
Capnography measures ETCO2 which reflects ventilation-an indication of how well the patient is
managing the mechanics of breathing. Pulse oximetry reflects oxygen saturation of the blood, or how
much oxygen is getting into the blood after passing through the lungs. A low SPO2 can alert the nurse
to a ventilation problem, but only because that problem has caused an oxygenation problem (Carlisle,
2014).
SOAPME
Many providers have developed mnemonics in order to remind themselves of what should be
in place prior to starting PSA. One such mnemonic is SOAPME:
S (suction) – size appropriate suction catheters, Yankauer tip suction, and a functioning suction
regulator
O (oxygen) – adequate oxygen supply, functioning flow meter, nasal cannulas, simple face
masks, and non-rebreather face masks
A (airway) - nasal and oral airways, laryngeal mask airways, bag-valve-mask (BVM) with a
correctly sized face mask
P (pharmacy) – the analgesics and sedatives ordered for the patient, the reversal agents, and
emergency medications
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M (monitors) – stethoscope, cardiac, non-invasive blood pressure, pulse oximeter with size-
appropriate probes, ETCO2
E (extra equipment) – personal protective equipment, special equipment or instruments for
the procedure such as extra lighting, suture, dressings, irrigation fluid, etc.
Suction
Suction must be available during PSA. Emesis with or without aspiration is a rare event during
PSA, but when it does occur appropriate suctioning of gastric contents from the oral cavity and airway
may make the difference between a minor incident and a major injury. More often suctioning is used
as a way to clear the airway of secretions that can inhibit spontaneous ventilation, cause coughing,
gagging, and oxygen desaturation.
The best general-purpose option is an appropriately sized Yankauer suction tip that will readily
suction emesis and secretions from the upper airway. Suction catheters of various sizes may also be
useful, but these devices must be used cautiously because deep suctioning can stimulate vagal
responses as well as laryngospasm. Nasal suctioning should also be done with caution as it can result
in significant bleeding from the turbinates.
The suction regulator should be set at maximum suction, and with the on-off switch set at off.
If suction is needed, the provider will only have to turn the on-off switch to on to begin using the
devise. This saves time in the event suction is needed immediately.
Oxygen and oxygen delivery devices
Anytime PSA is administered a reliable source of oxygen must be present. This source is
typically the in-line oxygen that is provided through the wall. In cases where deep PSA is targeted and
oxygen delivery is critical, a second backup source of oxygen should be immediately available in the
event the in-line source of oxygen fails. Most often this would take the form of an E-cylinder of oxygen
with an oxygen flow meter attached. The backup oxygen tank must have at least thirty minutes of
oxygen at 10L/minute available.
Formula to determine the amount of time remaining in an E-cylinder
PSI remaining in tank x 0.28/desired liters per minute = time remaining in minutes
EXAMPLE
Regulator on the E-cylinder reads 1000 psi
1000 psi remain in the tank x 0.28 = 2800 ÷ 10 liters per minute
28 minutes of oxygen at 10 liters/minute remain
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The room or sedation cart should be stocked with appropriately sized nasal cannulas, simple
facemasks, and non-rebreather facemasks.
The nasal cannula will provide up to 44% oxygen. It is a low flow system where tidal volume from
the patient mixes with room air. The addition of each liter of oxygen flow increases the inspired
oxygen percent by approximately 4%. One liter of flow per minute increases FiO2 from 21% TO 24%
while six liters per minute will increase the FiO2 to 44%. Humidification should be used whenever
possible to decrease irritation and drying out of nasal membranes.
The simple facemask provides up to 60% FiO2. Flow rate is set at 6-10 liters per minute. The flow
rate must be six liters per minute or greater to prevent accumulation of carbon dioxide in the mask. A
non-rebreather mask at 10-15 liters per minute (or a flow rate to keep the reservoir bag inflated) can
achieve FiO2 concentrations of 60-90%.
Airway adjuncts
Oral airways are S-shaped devices that hold the tongue away from the
posterior wall of the pharynx. They are used only in unconscious patients. A patient
with an oral airway in place should never be left unattended; the oral airway can
cause vagal stimulation and stimulation of the gag reflex leading to laryngospasm,
vomiting, and aspiration.
Nasal airways are uncuffed tubes made of soft rubber or plastic. They are used
for the semiconscious or unconscious patient. A nasal airway is indicated when
insertion of an oral airway is technically difficult or impossible because of a strong gag
reflex, trismus, trauma around the mouth, or wiring of the upper and lower jaws.
The Laryngeal Mark Airway (LMA) has become popular for airway management during
anesthesia and in emergencies. During PSA it can be used to rescue the
airway if BVM ventilation is ineffective. It is a tube with an inflatable cuff
that is inserted blindly into the pharynx so that the cuff surrounds the
laryngeal inlet. It does not protect against aspiration. At UNMH
physicians, emergency medical technicians, paramedics, and respiratory
therapists are permitted to insert LMAs; RNs are not trained to insert LMAs at UNMH.
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Pharmacy
In addition to the ordered medications and reversal agents, medications that may be used to
treat complications during PSA should be immediately available. In the event of life threatening
dysrhythmias or cardiac arrest, resuscitative medications from the crash cart should be used.
Recommended medications for the unplanned treatment of complications include:
Albuterol Epinephrine
Atropine Ephedrine
Dextrose 50% Ondansetron (Zofran)
Diphenhydramine (Benadryl)
Monitors
All patients, regardless of the targeted level of sedation, age, or comorbidities are monitored
by pulse oximetry. The use of electrocardiography (EKG) is required for PSA III or greater.
Before moving into the intra-procedural phase of PSA, final verification that the patient, the
procedural area, and the providers are prepared is essential (see Table 8).
TABLE 8 PREPROCEDURAL VERIFICATION THE PATIENT, THE AREA, & THE PROVIDER ARE
PREPARED FOR PSA
The Patient The Area The Provider
IV access Essential Equipment History and Physical on the medical record
Questions answered Adequate lighting for the procedure and to assess the patient
Presedation risk assessment complete and on the medical record
Method of communication established
Translator must be provided if necessary
Method to call for help is easily accessible
Code button
If in an area with special access doors, someone must be available to let the code team in
Sedation plan documented
Outpatients: Transportation home and a reliable adult chaperone for six hours once home.
Time Out performed prior to initiation of the procedure
ALL team members present
Consent is accurate and on the medical record
Medication orders are written
Do you know where the family is
waiting or how to reach them?
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Intra-Procedural Phase
The intra-procedural phase of PSA includes the site and side marking (if applicable) and the
time-out aspects of the Universal Protocol (see Policies and Procedures for Universal Protocol Time-
Out and Procedural Sedation Conscious/Moderate on UHMH Intranet); the administration and
documentation of PSA medications, the assessment, monitoring and documentation of the patient’s
response to medications and the procedure; and the procedure itself. Pharmacologic Agents and Techniques
When selecting pharmacologic agents for PSA it is important to remember the goals of PSA:
Guard the patient’s safety and welfare
Minimize physical discomfort and pain
Control anxiety and minimize psychological distress
Control behavior and movement to allow for the completion of the procedure.
Return the patient to a condition that allows for safe discharge
In order to achieve these goals, the selection of appropriate medications is essential. The
provider must consider the targeted level of sedation, the pharmacological properties of the drug, the
patient’s unique traits, as well as the characteristics of the procedure; painful or non-painful and the
duration.
Definitions of Pharmacologic Principles
Pharmacokinetics. This area of pharmacology studies a drug’s onset of action, peak concentration
level, and duration of action. These occur through four processes:
Absorption is the process of moving a drug from the site of administration to the bloodstream.
It covers a drug’s progress from the time it is administered, through its passage to body tissues
until it reaches systemic circulation. If only a few cells separate the drug from systemic
circulation, absorption occurs more rapidly the drug’s onset of action will occur within seconds
or minutes. Drugs administered through the intravenous (IV) route bypass this process
because the drug is given directly into systemic circulation.
Distribution is the process by which the drug is delivered from systemic circulation to body
tissues and fluids. Distribution of a drug within the body depends on perfusion, solubility, and
protein binding. As the drug enters systemic circulation some of the drug binds to plasma
proteins, such as albumin. Plasma proteins have indentations on their surface that allows drug
molecules to bind to them. The drug molecules that are bound to plasma proteins are inactive.
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The remaining portion of the drug is free to move from the bloodstream into body tissues to
exert its effect.
Drugs are quickly distributed to organs that are highly perfused including the brain, heart, liver
and kidneys. Distribution to other internal organs, skin, fat, and muscle is slower. The ability of
a drug to cross a cell membrane depends on whether the drug is water-soluble or fat-soluble.
Lipid-soluble drugs easily cross through cell membranes; water –soluble drugs require cellular
energy to move across the cell membrane.
Metabolism is also known as biotransformation. It is the process by which the body changes a
drug from its administered form to a more water –soluble form that can be excreted. Most
drugs are metabolized by enzymes in the liver. Some drugs inhibit or compete for enzyme
metabolism, which can cause the accumulation of drugs when they are given together. This
accumulation can increase the risk for adverse drug reactions or drug toxicity. Metabolism is
slowed by liver disease as well as heart failure, which decreases blood flow to the liver.
Genetic differences in liver enzymes can also affect the rate of drug metabolism. Age also
affects drug metabolism. Infants have immature livers that reduce the rate of metabolism, and
the elderly experience a decrease in liver size, perfusion, and enzyme production that also
slows metabolism.
Excretion refers to the elimination of drugs from the body. Most drugs are excreted by the
kidneys and leave the body through urine. Drugs can also be excreted through the lungs, sweat
glands, skin, and the intestinal tract. The half-life of a drug is the time it takes for half of the
drug to be eliminated by the body. Knowing how long a drug remains in the body helps
determine how frequently it can be administered. A drug that is only given once is eliminated
by the body in four or five half-lives. Steady state refers to the state when the rate of drug
administration equals the rate of drug excretion.
Onset of action refers to the time interval from when the drug is administered to when its
therapeutic effect begins.
Peak effect occurs when the absorption rate equals the elimination rate. The time to peak
effect is very important in determining titration intervals.
Duration of action is the length of time the drug produces its effect.
Pharmacodynamics is the area of pharmacology concerned with how drugs produce changes in
the body and the differences in patient responses to medication. Variables in patient response to
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medications include extremes of age, body weight and composition, disease states (cardiovascular,
hepatic and renal), current medications, psychological and emotional state, gender, and genetics.
Refer back to table 3 for a summary of specific factors that will affect the patient’s response to PSA
drugs.
Medication Principles
Titration or infusion of PSA medications is safer than boluses.
Primary factor in titration intervals is peak. It is imperative to avoid the repeated
administration of medications before the peak effect of a previous dose has been reached,
thus resulting in an excessive total drug effect over time (dose stacking).
The sedation provider must also recognize the risks associated with the use of combinations of
medications. For example, when opiates are added to benzodiazepines respiratory depression
is much more likely than when either of these drugs classes are used by themselves.
Dosing should be based on ideal body weight especially in pediatric populations.
Know each medication’s proper use, side effects, and pharmacokinetic/pharmacodynamics
characteristics.
Dosage should be reduced in the chronically ill and patients over age 60.
For safety, all drug dosages, drug to drug interactions and usage restrictions should be checked
using an on –line system such as Lexicomp.
Pharmacologic Agents
Sedation and analgesia may be provided by a wide variety of drugs that differ significantly in
terms of their pharmacological classifications and effects. The most widely used include the
benzodiazepines and opiates, other agents used include intravenous rapid acting sedatives. For
children, barbiturates and dissociative agents are commonly used.
Benzodiazepines (BNZs)
Benzodiazepines are commonly used alone for minimal sedation (anxiolysis). They produce
excellent sedative, muscle relaxation, amnesia, and anti-anxiety effects. They are highly protein
bound, metabolized by the liver, and excreted primarily in the urine. They provide no analgesia and
the sedative effect is dose dependent. Arterial blood pressure, cardiac output, and peripheral vascular
resistance are slightly decreased with the administration of benzodiazepines. Benzodiazepines
depress the ventilator response to carbon dioxide. Elderly and pediatric patients may exhibit a
paradoxical effect manifested by irritability, agitation, hostility, hallucinations, and anxiety or
inconsolable crying.
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Other benzodiazepines such as diazepam and lorazepam have relatively prolonged onset and
duration of action and are therefore less suited for PSA. Midazolam’s clearance is reduced in critically
ill patients, and patients with liver disease, shock, or those who are concurrently receiving enzyme-
inhibiting drugs such as cimetidine or ciprofloxacin.
VERSED (MIDAZOLAM)
Versed Onset Duration Peak
IV dose
Usual dose 0.5mg-2mg, slowly Slow IV: 1 to 2 mg Repeat dosage q2min prn; Max: 0.1 mg/kg (10 mg)/h
1-5 min 30 min-2h 5-7 min
IM dose 1-5 mg 15 min 30 min-2h 0.5 to 1 hour
Nasal Usual dose 5-10 mg 5 min 30 min-2h 5-7 min
Oral Usual dose 2-4 mg 10-20 min 3-8 hours 0.2 to 3 hours
50% dose reduction for patients >60yo or debilitated Can cause hypotension and bradycardia with fast injection. Paradoxical agitation Provides retrograde amnesia, mild anxiolysis and mild sedation for procedures that do not require
immobility. Individualize dose based on patient’s age, underlying diseases and concurrent medications. Decrease dose (by ~30%) if narcotics or other CNS depressants are administered concomitantly. In patients with renal failure, reduced elimination of metabolites leads to drug accumulation and
prolonged sedation. Personnel and equipment needed for standard respiratory resuscitation should be immediately
available during midazolam administration.
Versed Onset Duration Peak
IV dose
Usual dose 0.025-0.1 mg/kg, slowly Slow IV: 1 to 2 mg Repeat dosage q2min prn; Max: 0.1 mg/kg (10 mg)/h
1-5 min 30 min-2h 5-7 min
IM dose 1-5 mg 15 min 30 min-2h 0.5 to 1 hour
Nasal Usual dose 5-10 mg 5 min 30 min-2h 5-7 min
Oral Usual dose 2-4 mg 10-20 min 3-8 hours 0.2 to 3 hours
Contraindications: sensitivity/allergy to other benzodiazepines,
acute narrow angle glaucoma, use in open angle glaucoma only if
appropriate medical therapy is in force Reverse with
Flumazenil (Romazicon)
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Versed (midazolam) is short-acting, water –soluble benzodiazepine with a more predictable
level of amnesia than valium and Ativan. It usually it is combined with an opiate (most often fentanyl)
for PSA. When combined with other agents, respiratory depression, cardiovascular depression and
even hemodynamic collapse may occur.
Ativan Onset Duration Peak
IV dose
Usual dose 0.5mg-2mg, slowly Slow IV: 1 to 2 mg Repeat dosage q2min prn; Max single dose 4mg
5-10 min 6-8 h 1-3 h
IM dose 1-5 mg 15-30 min 6-8 h 1-3 h
Individualize dose based on patient’s age, underlying diseases and concurrent medications. May worsen hepatic encephalopathy, consider dose reduction in hepatic impairment Provides retrograde amnesia, mild anxiolysis and mild sedation; Anesthesia premedication agent Use is not recommended in severe renal and hepatic impairment. Personnel and equipment needed for standard respiratory resuscitation should be immediately
available during midazolam administration.
Opiates
Opiates provide analgesia and sedation during PSA. Opiates suppress the cough reflex and cause
respiratory depression, drowsiness and sedation.
Fentanyl is used most often due to its rapid onset and short duration of action. Meperidine
(Demerol) is favored for some GI procedures but generally is not used because its longer duration of
action and the active metabolite has neurotoxic effects. Morphine is another option but often is
avoided because of its slow onset and concern about stimulating smooth muscle contraction and
inducing spasm of the sphincter of Oddi, which may be a particular problem during endoscopic
retrograde cholangiopancreatography (ERCP).
Flumazenil can reverse effects, but use with caution in children with seizure disorder or who use benzodiazepines chronically.
The dose of midazolam needs to be individualized based on the patient’s age. Children <6 years: may require higher doses and closer monitoring than older children; calculate
dose on ideal body weight. Children 12-16 years: Dose as adults; usual maximum total dose: 10 mg (UNMH Pharmacy, 2011)
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Fentanyl (Sublimaze)
Fentanyl is an analog of Meperidine that is 75-100 times more potent than morphine. It binds to
opiate receptors in the central nervous system, altering the response to and perception of pain and is
a CNS depressant. Unlike Demerol and Morphine, Fentanyl does not cause a histamine release
Fentanyl’s duration of action is limited by its rapid distribution into fat tissue. However, after
repeated dosing or continuous infusion administration, fat stores may become saturated, thereby
prolonging its elimination. Rapid IV administration of this medication can lead to a rigid epiglottis or
chest wall rigidity and difficulty in breathing or ventilation of the patient. This effect may be reversed
with naloxone OR may require Rapid Sequence Intubation. This is a medical emergency requiring
immediate action.
Fentanyl Onset Duration Peak
IV Usual dose 25-50mcg slowly every 5 minutes Max single dose 100 mcg
1-2 min 30-60 min 3—5 min
IM Usual dose 25-50mcg Max single dose 100 mcg
7-8 min 1-2 h
Fentanyl Onset Duration Peak
IV Usual dose 0.5-1 mcg/kg Max single dose 3 mcg/kg
1-2 min 30-60 min 3—5 min
IM Usual dose 1-2 mcg/kg Max single dose 3 mcg/kg
7-8 min 1-2 h
Nasal Usual dose 1-2 mcg/kg Max single dose 50 mcg
5-10 min Varies
There is an increased risk of hypotension with concurrent use of benzodiazepines. Higher doses may be needed in some instances based on individual response. May cause Muscle rigidity; Diaphoresis; Laryngospasm Avoid use in patients who have received MAO inhibitors within the previous 14 days.
It may produce unpredictable, potentially fatal reactions.
CAUTION Give via slow IV push
Do not administer rapidly!
Contraindications: patient has taken MAO inhibitors within 14 days, hypersensitivity to Meperidine or any component of the formulation, pregnancy (prolonged use or high doses near term).
Reverse with Narcan
(Naloxone)
39
Meperidine (Demerol)
Onset Duration Peak
IV Usual dose 12.5-25 mg Max single dose 50 mg
5 min 2-3 h 1 h
IM Usual dose 25-50 mg Max single dose 50 mg
10 min 2-4 h varies
Repeat doses not recommended American Pain Society (2008) and ISMP (2007) do not recommend use as an analgesic Do not use with renal failure or history of seizures Metabolite may accumulate, particularly in patients with impaired renal function. Metabolite is neurotoxic. Accumulation may precipitate anxiety, tremors or seizures. Naloxone does not reverse and may even worsen neurotoxicity. See Lexicomp for a complete list of cautions and contraindications
Caution: May cause hypotension; use with caution in patients with hypovolemia, cardiovascular disease or drugs which may exaggerate hypotensive effects
Meperidine (Demerol)
Onset Duration Peak
IV 0.5-1 mg/kg 5 min 2-3 h 1 h
IM 0.5-1 mg/kg 10 min 2-4 h varies
Children are at an increased risk for seizures due to accumulation of metabolites. It is not recommended for procedural sedation in children.
40
Morphine Onset Duration Peak
IV Usual dose 1-2 mg Max single dose 5 mg
5 min 2-4 h 30 min
IM Usual dose 2-4 mg Repeat doses not recommended
10-30 min
4-5 h varies
Naloxone can reverse effects, use with caution in opiate dependent patients Hypotension due to histamine release IM is not recommended due to painful administration, variable absorption,
and lag time to peak effect
Morphine >6 months and <50 kg
Onset Duration Peak
IV Usual dose 0.05-0.1 mg/kg Max single dose 5 mg
5 min 2-4 h 30 min
IM Usual dose 0.05-0.1 mg/kg Max single dose 10 mg Repeat doses not recommended
10-30
min
4-5 h varies
Ketamine (Ketalar)
Ketamine is a phencyclidine derivative that acts as a dissociate sedative. It produces a trance-
like state and provides sedation, analgesia, amnesia and immobilization. Upper airway muscle tone
and protective airway reflexes usually remain intact. It is often used for brief, painful procedures in
children. Atropine or glycopyrrolate may be administered to reduce the side effect of hyper-salivation.
Because of its rapid onset, relatively short duration of action, and excellent sedative and analgesic
properties, it is often used for brief, painful procedures, such as fracture reduction or laceration repair.
Ketamine can exacerbate schizophrenia and is absolutely contraindicated in patients with
schizophrenia. Due to the higher risk of airway complications, ketamine is absolutely contraindicated
in children less than 3 months of age. Rapid I.V. administration or overdose may cause respiratory
depression or apnea. Resuscitative equipment should be available during use.
“The underlying pharmacology of ketamine is fundamentally different from that of other
procedural sedation and analgesia agents. This drug exerts its effect by “disconnecting” the
thalamocortical and limbic systems, effectively dissociating the central nervous system from outside
stimuli (e.g., pain, sight, sound). The resulting trancelike cataleptic state of “sensory isolation” is
characterized by potent analgesia, sedation, and amnesia while maintaining cardiovascular stability
Reverse with Narcan
(Naloxone)
41
and preserving spontaneous respirations and protective airway reflexes. Complete analgesia permits
performance of extremely painful procedures” (Green et al., 2011).
Ketamine can cause post-anesthetic emergence reactions which can manifest as vivid dreams,
hallucinations, and/or frank delirium. These reactions are less common in patients less than 15 years
of age and greater than 65 years when given intramuscularly. Emergence reactions, confusion,
irrational behavior may occur up to 24 hours postoperatively and may be reduced by pretreatment
with benzodiazepine and the use of ketamine at the lower end of the dosing range. Prophylactic pre-
treatment with benzodiazepines is no longer recommended in the pediatric population (Green et al.,
2011). Creating a calming peaceful environment and positive mental imagery before administration of
ketamine can reduce emergence delirium.
Ketamine Onset Duration Minimum
Interval
IV Usual dose 0.2-1 mg/kg IV over one to two minutes Repeat dose 0.5 mg/kg
0.5 min 5-10 min 10 min
IM Usual dose 2-4 mg/kg Repeat dose 2mg/kg Max single dose 4 mg/kg
10-30 min
15-25 min 10 min
Nasal Usual dose 0.5-2 mg/kg Max single dose 200 mg
8-12 min 45-60 min Repeat doses not recommended
May cause: Emergence delirium, Increased blood/intraocular pressure, Laryngospasm Salivation, Tachycardia
Educate accompanying family about the unique characteristics of the dissociative state if they will be present during the procedure or recovery.
Frame the dissociative encounter as a positive experience. Consider encouraging adults and older children to “plan” specific, pleasant dream topics in advance of sedation (believed to decrease unpleasant recovery reactions).
Ketamine Onset Duration Minimum Interval
IV Usual dose 0.5-1 mg/kg IV over one to two minutes Repeat dose 0.5 mg/kg
0.5 min 5-10 min 10 min
IM Usual dose 2-4 mg/kg Max single dose 4 mg/kg
10-30 min
15-25 min 10 min
Nasal Usual dose 5 mg/kg Max single dose 200 mg
8-12 min 45-60 min Repeat doses not recommended
Absolutely contraindicated in children under 3 months Emphasize, especially to school-aged children and teenagers, that ketamine delivers sufficient
analgesia, so there will be no pain
42
Propofol
Propofol is a potent, ultra-short acting sedative-hypnotic agent. Its mechanism of action is
unknown but is thought to mediate GABA activity. Propofol is contraindicated in hypersensitivity to
eggs, egg products, soybeans, or soy products; or when general anesthesia or sedation is
contraindicated. Propofol has no analgesic properties. It is associated with a rapid deepening of
sedation level to that of general anesthesia. This is considered monitored anesthesia care sedation
(MAC) and, by UNMH policy and guidelines, not given by RNs at UNMH. Its use is restricted at UNMH
to the OR, ICU (infusion less than 24 hours) and the Emergency Department. Propofol may be pushed
by the physician during a PSA case and the nurse monitoring the patient will need to ensure the
patient retains an adequate airway until the effect of the drug wears off.
The major cardiovascular effect of propofol is hypotension especially if patient is hypovolemic
or if bolus dosing is used. Hypotension may be substantial with a reduction in mean arterial pressure
occasionally exceeding 30%. Use with caution in patients who are hemodynamically unstable,
hypovolemic, or have abnormally low vascular tone (eg, sepsis).
Propofol vials and prefilled syringes have the potential to support the growth of various
microorganisms despite product additives intended to suppress microbial growth. To limit the
potential for contamination, strictly adhere to recommendations for handling and administering
propofol.
Sucrose
Sucrose has been found to be safe and effective when used for single event procedural pain,
such as in venipuncture or lumbar puncture, for infants less than 6 months old. The mechanism of
action may be related to the release of endogenous opiates as a result of the sweet taste. Administer
0.1 ml to 2 ml of a 25% sucrose solution up to 50% solution divided in each cheek and allow the infant
to suck on a pacifier. Administer no more than 2 minutes before beginning the procedure, and may
repeat dose, but not to exceed 2 doses in one hour.
Dexmedetomidine (Precedex)
Dexmedetomidine is often used for pediatric sedation during radiology studies. Its use is
limited to administration by LIP only. Please refer to UNMH policy Pediatric Sedation Protocol for
Radiology Studies using Dexmedetomidine.
43
Behavioral Treatments
Behavioral and cognitive treatments; desensitization, play enacting clinical situations,
exploration of equipment, distraction, reinforcing coping skills, positive reinforcement and relaxation
may all be used in conjunction with pharmacologic interventions. Parental anxiety is a predictor of
child anxiety. Keep parents involved and prepare them to take a positive role in allaying their child’s
fear, (Hsu, 2010).
REVERSAL AGENTS
Concerns related to adverse effects: Acute opioid withdrawal: May precipitate symptoms of
acute withdrawal in opioid-dependent patients, including pain, hypertension, sweating, agitation,
irritability; in neonates: shrill cry, failure to feed. Carefully titrate dose to reverse hypoventilation; do
not fully awaken patient or reverse analgesic effect (postoperative patient).
Disease-related concerns: Use with caution in patients with cardiovascular disease or in
patients receiving medications with potential adverse cardiovascular effects (e.g., hypotension,
pulmonary edema or arrhythmias); pulmonary edema and cardiovascular instability, including
ventricular fibrillation, have been reported in association with abrupt reversal when using narcotic
antagonists. Administration of naloxone causes the release of catecholamines; may precipitate acute
withdrawal or unmask pain in those who regularly take opioids. Use caution in patients with history of
seizures; avoid use in treatment of meperidine-induced seizures.
Naloxone (Narcan)
Onset Duration Minimum Interval
IV Dose Range 0.04-0.4 mg Usual Dose 0.2 mg Repeat dose every 2-3 min to reach *desired effect Max total dose 10 mg
1-2 min Varies 2 min
IM Usual dose 0.4-2 mg Max single dose 2 mg
2-15 min Varies 15 min
Nasal Usual dose 2 mg Note: Onset of action is slightly delayed compared to IM or IV
8-13 min Varies 15 min
OPIATE REVERSAL
44
FLUMAZENIL (ROMAZICON)
Onset Duration Minimum Interval
IV 0.2 mg over 15 seconds Repeat doses 0.2 mg at 1-minute intervals to reach desired LOC Max single dose 0.2mg Max total dose 3 mg/h
1-3 min 60 min 1 min
Benzodiazepine Overdose Caution with seizure history and chronic benzodiazepines In the event of re-sedation: Repeat doses may be given at 20-minute intervals with maximum
of 1 mg/dose and 3 mg/hour
FLUMAZENIL (ROMAZICON)
Onset Duration Minimum Interval
IV Usual dose 0.01 mg/kg Repeat dose 0.01 mg/kg every 2-3 min to reach desired reversal effect Max single dose 0.2mg Max total dose 1 mg
1-3 min 60 min 1 min
Total cumulative dose of 0.05 mg/kg or 1 mg, whichever is lower
*Desired effect = adequate ventilation without significant pain May need to re-administer dose(s) at a later interval (i.e., 20-60 minutes) depending on
type/duration of opioid If no response is observed after 10 mg, consider other causes of respiratory depression. Note: opioid-dependent patients may require lower doses (0.1 mg) titrated
incrementally to avoid precipitating acute withdrawal. IM may be required if the IV is unavailable
Naloxone (Narcan)
Onset Duration Minimum Interval
IV Usual dose 0.001-0.015 mg/kg Max single dose 2 mg Max total dose 10 mg
0.5 min 5-10 min 2 min
IM Usual dose 0.01 mg/kg Max single dose 2 mg
10-30 min
15-25 min 15 min
Nasal Recommended dose 4 mg May repeat every 2-3 min Max total dose 10 mg
n/a n/a n/a
American Academy of Pediatrics does not endorse IM administration since absorption may be erratic or delayed
BENZODIAZEPINE REVERSAL
45
Re-sedation: Repeated doses may be given at 20-minute intervals as needed; repeat
treatment doses of 1 mg (at a rate of 0.5 mg/minute) should be given at any time and no more than 3
mg should be given in any hour. After intoxication with high doses of benzodiazepines, the duration of
a single dose of flumazenil is not expected to exceed 1 hour; if desired, the period of wakefulness may
be prolonged with repeated low intravenous doses of flumazenil, or by an infusion of 0.1-0.4
mg/hour. Most patients with benzodiazepine overdose will respond to cumulative dose of 1-3 mg and
doses >3 mg do not reliably produce additional effects. Rarely, patients with partial response at 3 mg
may require additional titration up to a total dose of 5 mg. If a patient has not responded 5 minutes
after receiving a cumulative dose of 5 mg, the major cause of sedation is not likely to be due to
benzodiazepines.
Respiratory depression: Establishing an airway and assisting ventilation, as necessary, is
always the initial step in overdose management. Do not reply upon to reverse respiratory
depression hypoventilation alone. Flumazenil is not a substitute for evaluation of oxygenation.
**If a reversal agent is used, monitor the patient for at least 2 hours. The reversal agent
duration of action is often shorter than the opioid or benzodiazepine and will require repeat
administration. An on-line safety intelligence event (PSI) report should be completed.
The PSA proceduralist supervises drug administration and performs the procedure; the PSA
practitioner continuously monitors the patient while administering medications. To safely administer
PSA, the PSA practitioner continuously monitors the patient’s physiologic and psychological responses
to the medications and to the procedure. The person monitoring the patient must have no other
responsibilities that would require leaving the patient unattended or compromising continuous
patient monitoring during the procedure. This allows for early detection of potential complications
and increases the likelihood of achieving desired outcomes for the patient. There should be additional
personnel present if the proceduralist needs assistance to perform the procedure.
At the start of the procedure document the Modified Aldrete Score. This will be repeated at
recovery and prior to discharge. This system provides a standardized method of evaluating the
patient’s baseline and recovery. The person monitoring the patient must remain 1 to 1 with the
patient until the Aldrete score is 8 or above or has returned to baseline.
46
Modified Aldrete Score
Activity (able to move voluntarily or on command) Score
Four extremities……………………………………………………… 2
Two extremities…………………………………………............. 1
Unable to move………………………………………………………. 0
Respiration
Able to deep breathe and cough freely…….................. 2
Dyspnea or limited breathing……………………………………. 1
Apneic……………………………………………………………………….. 0
Circulation
BP & HR +/- 20% of pre-anesthesia level………………….. 2
BP & HR +/- 20-50% if pre-anesthesia level………………. 1
BP & HR +/- 50% of pre-anesthesia level…………………… 0
Consciousness
Fully awake (able to answer questions)……………………. 2
Arousable on calling (arousable only to calling)……….. 1
Not responding…………………………………………………………. 0
Oxygenation
Able to maintain O2 saturation >92% on room air…….. 2
Needs O2 inhalation to maintain saturation >90%....... 1
O2 saturation <90%, even with O2 supplement…………… 0
In addition, the following should be documented at the start of the procedure: age appropriate
pain score, I.V. insertion/presence, position for the procedure.
Medication Safety
National Patient Safety Goal –all medication containers (including syringes) are labeled with:
Medication name Strength Quantity Diluent and volume Expiration date if not used within 24 hours
Medications are documented on the Procedural Sedation Flow sheet at the time they are
given. A total dose is scored and documented at the conclusion of the procedure. The total amount is
also documented on the E-MAR for those units using the electronic form.
47
Level of consciousness (LOC), blood pressure, pulse respirations, oxygen saturation (SpO2),
will be monitored and recorded every 1-2 minutes at the start of the procedure or when medications
are titrated then every 5 minutes during the procedure and every 10-15 minutes post-procedure.
The patient’s responses to verbal commands during a procedure serve as a guide to their level of
sedation. If moderate sedation has been achieved, the patient will be able to cooperate with the
procedure and control their own airway. Responses to verbal commands would indicate an
appropriate response, for example “take a deep breath”. Other examples may include “squeeze my
hand if you’re having pain” or the ability to give a thumbs up/down sign. Stimulation may include
stroking the patient’s arm or gently shaking an extremity.
The following categories appear as the level of consciousness key on the Procedural Sedation
Flow sheet.
Categories Qualifying Term
0 Unresponsive a Confused
1 Responds to pain b Restless
2 Responds to Verbal Stimuli c Crying
3 Drowsy Responds Easily d Talking
4 Awake e Following Commands
f Oriented
One of the categories on the left are selected and then qualified with a term from the list on the right.
For example, if the patient is awake and talking, 4/d is recorded on the flow sheet.
Oxygenation should be monitored by continuous pulse oximetry. Hypoventilation and
resultant hypercapnia may precede a decrease in hemoglobin oxygen saturation by several minutes.
The clinician needs to remember that pulse oximetry gives no information regarding the adequacy of
ventilation. Careful evaluation and documentation of respiratory status will include respiratory rate,
observation of chest movement and patient’s color. If available, end tidal CO2 monitoring
(Capnography) is recommended. Most areas have Capnography available and this should be used as a
monitoring tool for sedation cases.
Drug-induced respiratory depression and airway obstruction are the primary causes of
morbidity associated with sedation/analgesia. Sedatives, hypnotics, and analgesics may decrease
oropharyngeal muscle tone. Relaxation may lead to obstruction if the tongue blocks the upper airway.
Signs and symptoms of airway obstruction include:
48
Tachypnea
Tachycardia
Hypoxemia (falling pulse oxygen saturation).
Hypercarbia (rising carbon dioxide level).
Absence of breath sounds.
Increased respiratory effort, sternal retractions
Change in color
Upper Airway Obstruction
INTERVENTIONS
1. Auditory/tactile stimulation (tell the patient to take a breath) 2. Head tilt/chin lift or jaw thrust 3. Insert nasal/oral airway
Head tilt is a mechanical maneuver that moves the head
to a neutral position. Complete or partial relief of upper airway
obstruction may occur after use of maneuver.
If the head tilt is unsuccessful, a chin lift may be used. Often
they are done simultaneously. The chin lift permits anterior
movement of the mandible through superior displacement of
the chin (simply – pulling the chin up). Coupled with
hyperextension of the head and neck, this maneuver results in anterior displacement of the tongue
and relief of the airway obstruction (the tongue comes forward and the airway opens). If there is
concern about the neck, a jaw thrust may be used to displace the tongue and open the airway.
When positioning the head to open the airway, it is important to remember anatomic and
physiologic differences in adults and children. Infants under the age of 6 months are obligate nose
breathers. In children of preschool age, the tonsils and adenoids occupy a larger portion of the airway
than any other age group. The child’s tongue is large in relation to the mouth. The large tongue and
shorter distance between the tongue and the hard palate makes rapid airway obstruction possible.
The larynx and trachea are soft and susceptible to compression with improper positioning of the neck.
The narrowest portion of the upper airway is at the level of the cricoid ring.
In children, the airway may be occluded if the head is hyperextended. The head position is
more neutral and often can be obtained by placing a folded towel or bath blanket (depends on size of
c
49
child) beneath the shoulder blades of the child and allow the head to hang off in a more neutral
position.
When upper airway obstruction continues after the maneuvers just outlined, an artificial
airway is required to physically displace the tongue. Nasal airways are generally better tolerated than
oral airways. Oral airways are more likely to stimulate gagging or retching and could precipitate
aspiration.
Key Point Patients who require invasive forms of airway support have exceeded the
definition of moderate sedation. By definition, patients must
“independently” maintain their own airway. The need to mechanically
assist with maintenance of a patent airway denotes your patient has
moved into a deeper than desired level of sedation.
Laryngospasm
Laryngospasm is a potential complication of PSA caused by mucus, blood or saliva irritating the
vocal cords resulting in complete or partial closure of the cords. The irritant causes an exaggeration of
the protective glottis closure reflex. Signs and symptoms include acute respiratory distress,
hypercarbia, rocking chest motion, dyspnea, inspiratory stridor, and hypoxemia.
The following conditions increase the risk for laryngospasm: smoking, asthma, reactive airway
disease, GERD, obstructive sleep apnea, respiratory tract infection, hypoparathyroidism with
hypocalcemia, nasogastric tube or upper aero-digestive tract endoscope.
Management includes providing positive pressure ventilation with a BVM and 100% oxygen (a
secure mask fit is required). If this maneuver is unsuccessful, summon an experienced airway manager
(anesthesiologist) immediately. A non-paralyzing dose (approximately one tenth of the full
intubating dose) 0.5 mg/kg I.V. of succinylcholine may be required. Endotracheal intubation may be
necessary if other measures are unsuccessful.
50
Ventilate the patient with a bag-mask devise. Reassess for both
patency of the airway and adequacy of ventilation and oxygenation.
A properly fitting mask should fit snugly between the bridge of the
patient’s nose, the chin, and the medical aspects of the face. Rise and
fall of the chest with ventilation and auscultation of equal breath sounds
and rise of SpO2 will indicate proper fit.
Depending on medications used, reversal agents are indicated. If
a benzodiazepine and opioid agent were given, Naloxone (Narcan) will
reverse the respiratory depression due to the opiate; Flumazenil (Romazicon) will reverse the central
nervous system effects of the benzodiazepine.
Medications used may directly depress cardiac function. In addition, they may impair the
ability of the autonomic nervous system to compensate for hemodynamic changes. Circulation should
be assessed by determining heart rate and blood pressure every 1-2 minutes during the onset of
sedation, when titrating medications and then every 5 minutes during the procedure. Hypotension
should be evaluated and treated according to cause and symptoms. Increasing I.V. fluids (giving a
bolus), raising legs, use of vasopressors and/or reversal agents may be necessary if symptomatic.
Continuous ECG will be displayed during the course of the procedure for all patients with
underlying cardiovascular disease, for procedures with an increased risk of dysrhythmia and all
patients with an ASA score III or higher. Symptomatic dysrhythmia that occurs during sedation should
be treated according to age appropriate ALS protocol.
Baseline temperature should be taken on all patients receiving PSA. Patients, particularly
those who are sedated and exposed to cool ambient temperatures, are at risk for hypothermia.
Moderate hypothermia is associated with increased risk for coagulopathy, shivering and patient
discomfort. Care should be given to keep the patient warm and comfortable.
Nausea and vomiting are common side effects of many of the medications used for moderate
sedation. Proper positioning: either turning the patient to their side or assisting them to sit up may
prevent aspiration. Suction should be available to clear the airway if necessary.
Documentation – The Procedural Sedation Flow Sheet is available on the UNMH Intranet
under the heading Clinical then clinical forms. It is anticipated that all units where procedural sedation
is being given will have the ability to use the electronic sedation record by the middle of 2016. At that
time, the paper form should only be used during downtime.
51
Document the pre-procedural assessment, time out, pain management, I.V. start, the
procedure, patient responses, medications, VS and LOC every 1-2 minutes at the start and if any
additional medications are given, every 5 min during the procedure, then every 10-15 minutes post-
procedure, Modified Aldrete scores, and discharge. Any additional information may be added to the
narrative portion of the flow sheet. If the patient is ASA III or higher, attach a baseline ECG strip to the
Procedural Sedation Flow Sheet and another at the end of the procedure. If there are any changes in
rhythm, add additional strips to document the changes. All members of the care team should sign the
procedural flow sheet.
Post Procedural Phase
Transfer The patient may be transferred when the Modified Aldrete score is 8 or above or the
patient has returned to baseline. For transfer within the hospital, use the hand-off communication,
(ISBAR) process. The ISBAR policy is available on the UNMH Intranet under Policies and Procedures.
Discharge Home Prior to discharge the patient and caregiver should receive written
instructions including emergency contact information. In addition to a Modified Aldrete score of 8 or
above:
The patient should return to baseline ambulatory status.
If the patient has any pain or nausea, it is well controlled. (Complete the post-procedure pain assessment)
Voiding is not required but the patient should be given instructions what to do if unable to void in 6-8 hours.
A caregiver must stay with the patient for 6 hours.
The patient cannot drive home.
The patient should not make any major decisions, drive or operate equipment for 24 hours.
A Patient Safety Intelligence (PSI) should be completed for any of the following outcomes:
A patient death
Aspiration
Use of a reversal agent
Unplanned transfer to a higher level of care
Use of other than approved agents
Emergency procedures without LIP present
Inability to complete the procedure as planned
Other triggers that a PSI should be filled out for include:
changes in status that require unexpected interventions
52
need for artificial airway
laryngospasm
bronchospasm
seizure
new onset arrhythmia
hypotension
acute MI
cardiac arrest or Dr. Heart call
hypoxia (Sp02 <90%)
aspiration
unexpected drug reaction/anaphylaxis
Capnography Definitions
Capnometry is the measurement of expired CO2 and provides a numeric display of CO2 tension in mm Hg or % CO2
Capnography is the graphic representation of expired CO2 over time
Capnograph is the measuring instrument
Capnogram is the waveform displayed by the capnograph
End-tidal CO2 (EtCO2) is the measurement of CO2 at the very end of expiration. It is the maximum concentration of expired CO2
PaCO2 is partial pressure of CO2 in arterial blood
Capnography is the non-invasive, continuous measurement of exhaled carbon dioxide concentration, commonly referred to as End Tidal Carbon Dioxide or EtCO2. The EtCO2 numeric value typically ranges between 35-45 mmHg.
This capnograph displays:
• a respiratory rate that is measured at the airway, • an EtCO2 numeric value, measured in millimeters of
mercury, and • a waveform tracing.
Since CO2 is measured with every exhalation it provides an accurate respiratory rate
• The EtCO2 value is useful for trending changes in ventilation status • The waveform provides a breath-by-breath representation of airway status (e.g. normal
breath, obstruction due to relaxing airway structures, no breath, etc.) • Only counts adequate breaths containing minimum of 7.5 mmHg CO2
• EtCO2 value also measured less frequently in volume percent in kilo Pascal
53
To understand the value of End Tidal CO2 monitoring, we must first understand the physiology of the respiratory cycle and gas exchange. The respiratory cycle is made up of two separate processes, oxygenation and ventilation.
• The first phase of the respiratory cycle is Oxygenation measured by Pulse Oximetry or SpO2.
• The second phase is ventilation measured by EtCO2 or capnography and is measured with each exhaled breath.
• These two related, but separate processes make up the entire respiratory cycle, allowing the body to replenish oxygen and eliminate CO2.
Different techniques can result in different respiration rates.
• Traditional respiratory monitoring reflects a single moment in time where you observe the patient’s chest rise and fall or listen to breath sounds. In addition, blankets, drapes or patient position can limit visualization of chest movement, and with complete airway obstruction there may continue to be chest movement as the patient attempts to breathe. Lastly, there is no automated documentation or alarm if your patient fails to breathe.
• Impedance Pneumography, or measuring RR with ECG leads; provides a respiratory rate based on respiratory effort ...the attempt to breathe or any other sufficient movement of the chest.
• Capnography measures respirations at the airway. A respiration is counted when there is a qualifying amount of carbon dioxide exhaled. It provides an accurate airway respiration rate, and hypoventilation and apnea are detected immediately
Two separate physiologic processes
• The process of getting O2 into the body
Oxygenation
• The process of eliminating CO2
from the body
Ventilation
54
Capnography - How to use the EtCO2 value?
• Normal range = 35-45 mmHg • Baseline EtCO2 and respiratory rate prior to sedation
• Baseline waveform assessment • Is value significantly out of normal range?
• Pause and assess (patient and waveform) • During procedure – Change from baseline?
• Pause and assess (patient and waveform)
**The numeric value must be evaluated in conjunction with the waveform and the patient.
Manual Counting
Measures:
•Chest or air movement
•Based on observation or auscultation that may be restricted by patient movement, draping or technique
Impedance (ECG Leads)
Measures:
•Attempt to breathe
•Chest movement
•Based on measuring respiratory effort or any other sufficient movement of the chest
EtCO2
Measures:
•Actual exhaled breath at airway
•Hypoventilation and No Breath detected immediately!
•Most accurate RR
55
The ABC’s of Waveform Interpretation
A – Airway: Look for signs of obstructed airway (steep, up sloping expiratory plateau)
B – Breathing: Look at EtCO2 reading. Look at waveforms, and for elevated respiratory baseline.
C – Circulation: Look at trends, long and short term for increases or decreases in EtCO2 readings
Capnogram – real time waveform
Trends – over a period of time • A slower speed provides a trend image of the peaks and troughs of expired CO2
• Track and follow ventilation patterns
Hypoventilation-Increasing CO2
56
With classic hypoventilation there is an increase in EtCO2 with a decrease in respiration rate. This may be seen when breathing is slower but with normal tidal volumes. Notice the waveform looks similar to the normal waveform; but it is increased in the size and the EtCO2 value is higher.
Decreased…Increased
Hypoventilation with shallow breathing is commonly observed with sedation and/or
analgesia, accidental overdoses, post-ictal patients, or obtunded states (post alcohol or illegal drug ingestions). During shallow breathing, the waveform may be rounded and smaller. Also, the EtCO2 numeric value will decrease. This is caused by shallow breathing, with relaxation of the throat muscles and tongue obstructing the airway, or due to a head or neck position that obstructs air flow.
When the patient takes a deep breath again, with good gas exchange; the waveform returns to its normal, square shape. It will often be increased in size, showing CO2 retention.
Hyperventilation- Decreasing CO2
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Loss of Alveolar Plateau
Partial airway obstruction
Airway obstructions can be seen with non-intubated patients who have a history of obstructive sleep apnea. It is caused by a relaxation of the throat muscles and tongue; obstructing the airway causing the waveform to become flat or almost flat. This can be a partial or complete obstruction.
When a non-intubated patient has a partial obstruction caused by relaxation of upper airway structures, the waveform becomes erratic; and as the obstruction progresses, the waveform will flatten. When the patient is stimulated and takes a deep breath again; the waveform returns to its normal, square shape. It may even briefly increase in size as the patient eliminates retained CO2.
In intubated patients, the partial obstruction waveform may be related to increased secretions or a displaced ETT.
Bronchospasm
Asthma, COPD, bronchitis….increased dead space mixes with CO2 softens rise in
CO2….distinguishing factor is the shark fin.
Apnea or….
In non-intubated patients, a complete flat line of waveform suggests apnea, total airway
obstruction, or a FilterLine kink/displacement. In intubated patients, a complete flat line of waveform suggests apnea, total airway
obstruction, or a misplaced or dislodged ETT; as well a FilterLine kink/displacement
58
Appendix
Useful information
Test
Age 5
0 -70
Age 7
0 +
Smo
king
BM
I 35
+
Hyp
erten
sion
Seizure M
edicatio
ns
Card
iovascu
lar Disease
Pu
lmo
nary D
iseases
Diab
etes
Hep
atic Disease
Ren
al Disease
Au
toim
mu
ne/Lu
pu
s
Steroid
Use
HIV
An
ticoagu
lation
Med
s
Sub
stance A
bu
se
EKG Y Y Y Y Y Y Y Y Y Y Y Y Y Y
CXR Y Y
CBC + Platelets
Y Y Y Y Y Y Y Y Y Y Y Y Y Y
Electrolytes
Y Y Y Y Y Y Y Y Y Y Y Y
BUN/Creatinin
e
Y Y Y Y Y Y Y Y Y Y Y
Glucose Y Y Y Y Y Y Y Y Y Y
Liver Funct
ion
Y Y Y Y
PT/PTT Y Y Y Y Y Y
Women of childbearing ability should have a Urine HCG the day of the procedure
59
“Adult Procedural Sedation” Power Plan
“Adult Procedural Sedation Medications” Power Plan
60
61
MEDICATIONS FOR MODERATE PROCEDURAL SEDATION (11-2015)
Drug Route Initial Onset
Duration of
Action
Adult Pediatric (<50kg)
Comments Usual Dose
Maximum Single Dose
Minimum Interval Usual Dose
Maximum Single Dose Minimum Interval
Fentanyl IV
1-2 minutes
0.5-1 hours
25-50 mcg
100 mcg 5 minutes 0.5-1 mcg/kg 3 mcg/kg
(50mcg/dose) 5 minutes (repeat ½ of initial dose)
Muscle rigidity
Diaphoresis
Laryngospasm
IM 7-8
minutes 1-2
hours 25-50 mcg
100 mcg 10 minutes 1-2 mcg/kg 3 mcg/kg
(50mcg/dose) 3 minutes (repeat ½ of initial dose)
Nasal 5-10
minutes Variable N/A N/A N/A 1-2 mcg/kg 50 mcg/nare 5 minutes
Morphine IV
5 minutes
2-4 hours
1-2 mg 5 mg 5 minutes 0.05-0.1 mg/kg
5 mg 5 minutes Hypotension due to histamine
release
IM is not recommended due to painful administration, variable absorption, and lag time to peak effect
IM 10-30
minutes 4-5
hours 2-4 mg Repeat dose not recommended
0.05-0.1 mg/kg
10 mg/dose Repeat dose not recommended
Meperidine IV
5 minutes
2-3 hours
12-25 mg 50 mg Repeat dose
not recommended
0.5-1 mg/kg 2 mg/kg
(50 mg/dose) Repeat dose not recommended
1. American Pain Society (2008) and ISMP (2007) do not recommend use as an analgesic; do not use with renal failure or history of seizures
IM 10
minutes 2-4
hours 25-50 mg 50 mg 0.5-1 mg/kg
2 mg/kg (50 mg/dose)
Midazolam IV
1-5 minutes
0.5-2 hours
1-2 mg 4 mg 5 minutes 0.025-0.1
mg/kg 4 mg 5 minutes
2. Hypotension and bradycardia with fast injection
3. Paradoxical agitation 4. 50% dose reduction for patients
>60yoa or debilitated
IM 15
minutes 0.5-2 hours
1-5 mg 5 mg 15 minutes 0.1-0.15 mg/kg
5 mg 15 minutes
Nasal 5
minutes 0.5-2 hours
5-10 mg 10 mg
(5 mg/nare) 10 minutes 0.2-0.3 mg/kg
10 mg (5 mg/nare)
10 minutes
Oral 10-20
minutes 3-8
hours 2-4 mg 10 mg
Repeat dose not
recommended
0.25-0.5 mg/kg
0.5 mg/kg (10 mg/dose)
Repeat dose not recommended
Lorazepam IV
5-10 minutes
6-8 hours
0.5-2 mg 4 mg 20 minutes 0.01-0.05
mg/kg 0.08 mg/kg (4 mg/dose)
20 minutes Hypotension and bradycardia with
fast injection
IM 15-30
minutes 6-8
hours 0.5-2 mg 4 mg 40 minutes 0.05 mg/kg
0.08 mg/kg (4 mg/dose)
40 minutes
Ketamine IV 0.5
5-10 minutes
0.2-1 mg/kg
repeat dose 0.5 mg/kg
10 minutes 0.5-1 mg/kg repeat dose 0.5
mg/kg 10 minutes
Emergence delirium Increased blood/intraocular pressure Laryngospasm Salivation Tachycardia
IM 3-4
minutes 15-25
minutes 2-4
mg/kg
4 mg/kg (2mg/kg repeat
dose) 10 minutes 2-4 mg/kg 4 mg/kg 10 minutes
Nasal 8-12
minutes 45-60
minutes 0.5-2
mg/kg 200 mg
(100 mg/nare)
Repeat dose not
recommended 5 mg/kg
200 mg (100 mg/nare)
Repeat dose not recommended
Dexmede-tomidine
IV 5-10
minutes 1-2
hours 0.5-1 mcg/kg LOAD over 10 minutes
Usual infusion range 0.2-1 mcg/kg/hr 0.5-1 mcg/kg (up to 2mcg/kg) LOAD over 10 minutes
Usual infusion range 0.2-1 mcg/kg/hr Hypertension, hypotension,
bradycardia, arrhythmias No reversal agent Administered by LIP
Nasal 15
minutes Variable Limited data 1-2 mcg/kg 3 mcg/kg Limited data
62
REVERSAL AGENTS
Naloxone
IV 1-2
minutes Variable by route Range is
0.5-3 hours
0.04-0.4 mg 2 mg 2 minutes 0.001-0.015
mg/kg 2 mg 2 minutes
Opiate Overdose IM may be required if the IV is
unavailable; the American Academy of Pediatrics does not endorse IM administration since absorption may be erratic or delayed
IM 2-15
minutes 0.4-2mg 2 mg 15 minutes 0.01 mg/kg 2 mg 15 minutes
Nasal 8-13
minutes 2 mg 2 mg 15 minutes Limited literature
Flumazenil IV
1-3 minutes
60 minutes
0.2 mg 1 mg 1 minute 0.01 mg/kg 0.2 mg/dose 1 mg (total)
1 minute Benzodiazepine Overdose Caution with seizure history and
chronic benzodiazepines
Moderate Sedation. Lexicomp Online. Hudson, Ohio: Lexi-Comp, Inc; Accessed 11/2/2015. Sedation. Lexicomp Online. Pediatric and Neonatal Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc; Updated 9/3/15. Accessed 11/2/15. Micromedex. Ann Arbor (MI): Truven Health Analytics; Access 11/2/15. Talon MD1, Woodson LC, Sherwood ER, Aarsland A, McRae L, Benham T. Intranasal dexmedetomidine premedication is comparable with midazolam in
burn children undergoing reconstructive surgery. J Burn Care Res. 2009 Jul-Aug;30(4):599-605. Jia JE1, Chen JY, Hu X, Li WX. A randomised study of intranasal dexmedetomidine and oral ketamine for premedication in children. Anaesthesia. 2013
Sep;68(9):944-9. Hegenbarth MA and American Academy of Pediatrics Committee on Drugs, "Preparing for Pediatric Emergencies: Drugs to Consider," Pediatrics. 2008.
121(2):433-43.
63
http://www.patientsafety.va.gov/docs/modSedationtoolkit/CognitiveAidStudy
Guide.pdf
64
http://www.patientsafety.va.gov/docs/modSedationtoolkit/CognitiveAidStudyGuide.pdf
65
http://www.patientsafety.va.gov/docs/modSdationtoolkit/CognitiveAidStudyGuide.pdf
66
http://www.patientsafety.va.gov/docs/modSedationtoolkit/CognitiveAidStudyGuide.pdf
67
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