Controversies in Procedural Controversies in Procedural Sedation and Induction in ERSedation and Induction in ER

February 2004February 2004

ControversiesControversies

REVIEW OF ANESTHESIA REVIEW OF ANESTHESIA GUIDELINESGUIDELINES

IS ETOMIDATE SAFE FOR ER IS ETOMIDATE SAFE FOR ER INDUCTION?INDUCTION?

IS PROPOFOL SAFE IN CHILDREN?IS PROPOFOL SAFE IN CHILDREN? IS KETAMINE SAFE IN HEAD INJURED IS KETAMINE SAFE IN HEAD INJURED

PATIENTS?PATIENTS?

ANESTHESIA GUIDELINESANESTHESIA GUIDELINES

PRACTICE GUIDELINES FOR PRACTICE GUIDELINES FOR SEDATION AND ANALGESIA BY NON-SEDATION AND ANALGESIA BY NON-ANESTHESIOLOGISTS ANESTHESIOLOGISTS ANESTHESIOLGY ANESTHESIOLGY 20022002

GUIDELINES FOR MONITORING AND GUIDELINES FOR MONITORING AND MANAGEMENT OF PEDIATRIC MANAGEMENT OF PEDIATRIC PATIENTS DURING AND AFTER PATIENTS DURING AND AFTER SEDATION –ADDENDUM SEDATION –ADDENDUM PEDIATRICS 2002PEDIATRICS 2002

ANESTHESIA GUIDELINESANESTHESIA GUIDELINES

ASA 2002ASA 2002 AAP 2002AAP 2002 EVIDENCE BASED CONSENSUS EVIDENCE BASED CONSENSUS

OPINION TASK FORCEOPINION TASK FORCE CAEP 1999CAEP 1999 ACEP 1998ACEP 1998

PEDIATRIC ADDENDUMPEDIATRIC ADDENDUM

DOCUMENTED PRESEDATION DOCUMENTED PRESEDATION MEDICAL EVALUATIONMEDICAL EVALUATION

APPROPRIATE FASTING INTERVALAPPROPRIATE FASTING INTERVAL SKILLED PERSONNELSKILLED PERSONNEL PULSE OXIMETRYPULSE OXIMETRY ASSIGNED MONITORING ASSIGNED MONITORING

INDIVIDUALINDIVIDUAL SPECIFIC DISCHARGE CRITERIASPECIFIC DISCHARGE CRITERIA

ASA PRACTICE GUIDELINESASA PRACTICE GUIDELINES

DEFINTION SEDATION DEPTHDEFINTION SEDATION DEPTH PRE PROCEDURE ASSESSMENTPRE PROCEDURE ASSESSMENT PRE PROCEDURE FASTINGPRE PROCEDURE FASTING MONITORING / CAPNOGRAPHYMONITORING / CAPNOGRAPHY ANCILLARY STAFFANCILLARY STAFF MEDICATIONSMEDICATIONS RECOVERY CARE/DISCHARGE RECOVERY CARE/DISCHARGE

CRITERIACRITERIA

LOCAL ANESTHESIA LOCAL ANESTHESIA CONCERNSCONCERNS

GENERAL ANESTHESIA IN ERGENERAL ANESTHESIA IN ER POOR DOCUMENTATIONPOOR DOCUMENTATION PRE PROCEDURE ASSESSMENTPRE PROCEDURE ASSESSMENT POST PROCEDURE RECOVERYPOST PROCEDURE RECOVERY DISCHARGE CRITERIADISCHARGE CRITERIA EDUCATIONAL PROCESSEDUCATIONAL PROCESS

DEPTH OF SEDATIONDEPTH OF SEDATION

SedationSedation ResponseResponse AirwayAirway VentVent CVSCVS

ModerateModerate purposepurpose normalnormal normalnormal normalnormal

DeepDeep RepeatedRepeated

painfulpainful

PossiblePossible

interveneintervene

PossiblePossible

abnormalabnormal

UsuallyUsually

normalnormal

GeneralGeneral

anesthanesth

NoNo

responseresponse

OftenOften

interveneintervene

FrequentFrequent

abnormalabnormal

Maybe Maybe

abnormalabnormal

Sedation DepthSedation Depth

Conscious Sedation removedConscious Sedation removed Dissociative Sedation not classifiedDissociative Sedation not classified All sedatives and narcotics can produce all All sedatives and narcotics can produce all

levels of sedation ,some are more likely to levels of sedation ,some are more likely to induce deep or general anesthesiainduce deep or general anesthesia

Deep and general anesthesia are more likely Deep and general anesthesia are more likely to be associated with adverse reactionsto be associated with adverse reactions

Sedation depth difficult to measureSedation depth difficult to measure

PRE PROCEDURE PRE PROCEDURE EVALUATIONEVALUATION

Guided RiskAssessment ToolGuided RiskAssessment Tool HOFFMAN PEDS 02 HOFFMAN PEDS 02

Snoring, Stridor Sleep apneaSnoring, Stridor Sleep apnea Airway abnormalitiesAirway abnormalities Vomiting, bowel obstructionVomiting, bowel obstruction Gastroesophageal refluxGastroesophageal reflux ASA classASA class Sedation FailureSedation Failure NPO statusNPO status

PRE PROCEDURE FASTING PRE PROCEDURE FASTING REQUIREMENTSREQUIREMENTS

ASA GUIDELINESASA GUIDELINES Liquids 2 hoursLiquids 2 hours Breast milk 4 hoursBreast milk 4 hours Solids 6 hoursSolids 6 hours NO SCIENTIFIC EVIDENCE TO NO SCIENTIFIC EVIDENCE TO

SUPPORT THIS CONSENSUS OPINIONSUPPORT THIS CONSENSUS OPINION TRACHEA and ESOPHAGEAL TRACHEA and ESOPHAGEAL

PROCEDURES NOT ROUTINE IN ER PROCEDURES NOT ROUTINE IN ER

PRE PROCEDURAL FASTINGPRE PROCEDURAL FASTING

ASPIRATION RISKASPIRATION RISK NO Published aspiration in ER> 30 yearsNO Published aspiration in ER> 30 years Risk of aspiration ~1/895 emergency Risk of aspiration ~1/895 emergency

surgery and ~1/3500 surgerysurgery and ~1/3500 surgery Two thirds aspiration during intubationTwo thirds aspiration during intubation Increased incidence of sedation failures Increased incidence of sedation failures

with prolonged fasting timeswith prolonged fasting times

FASTING LITERATUREFASTING LITERATURE

Pre procedural fasting adverse events ER Pre procedural fasting adverse events ER Agarwal et al Annals of Emergency Medicine 2003Agarwal et al Annals of Emergency Medicine 2003

Pediatrics prospective case series n=905Pediatrics prospective case series n=905 Adverse events minor 8.1%* incidence in Adverse events minor 8.1%* incidence in

compliant and 6.9%* in noncompliantcompliant and 6.9%* in noncompliant Emesis 1.5%Emesis 1.5% Medications ketamine/midazolam Medications ketamine/midazolam

fentanyl/midazolamfentanyl/midazolam

FASTING LITERATUREFASTING LITERATURE

Median fasting duration solids 9.6 *hours Median fasting duration solids 9.6 *hours vs 5.2 hours non compliantvs 5.2 hours non compliant

Median fasting duration clear liquids 8.5 Median fasting duration clear liquids 8.5 hours vs 4.7* hours non complianthours vs 4.7* hours non compliant

CONCLUSION There was no association CONCLUSION There was no association between preprocedural fasting state and between preprocedural fasting state and adverse eventsadverse events

????? What?????? What?

Preprocedural FastingPreprocedural Fasting

ACEP recent food intake is not a ACEP recent food intake is not a contraindication for administering PSA but should contraindication for administering PSA but should be considered in choosing the depth and target be considered in choosing the depth and target level of sedationlevel of sedation

CAEP Urgency of procedure and desired depth CAEP Urgency of procedure and desired depth of sedation should be weighed against the risk of sedation should be weighed against the risk associated with inadequate fastingassociated with inadequate fasting

ASA potential for aspiration must be considered ASA potential for aspiration must be considered in determining target sedation level, or whether to in determining target sedation level, or whether to delay or protect by intubationdelay or protect by intubation

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MONITORINGMONITORING

Level of consciousness Level of consciousness OxygenationOxygenation HemodynamicsHemodynamics Ventilation* capnographyVentilation* capnography

Ventilation CapnographyVentilation Capnography

ASA-- capnography may decrease risks ASA-- capnography may decrease risks during deep sedation during deep sedation

Capnography may decrease risks during Capnography may decrease risks during moderate and deep sedation when patient moderate and deep sedation when patient physically separated from caregiverphysically separated from caregiver

Supplemental oxygen decreases patient risk Supplemental oxygen decreases patient risk during deep sedationduring deep sedation

CapnographyCapnography

Measurement of endtidal CO2 infrared Measurement of endtidal CO2 infrared spectroscopy nasal cannulaespectroscopy nasal cannulae

Not as accurate as in intubated patientsNot as accurate as in intubated patients No evidence to suggest that it will reduce No evidence to suggest that it will reduce

complications but may alert to subclinical complications but may alert to subclinical respiratory depression respiratory depression

Respiratory depression- ETCO>50, increase Respiratory depression- ETCO>50, increase >10 from baseline, absent waveforem>10 from baseline, absent waveforem

Capnography LiteratureCapnography Literature

6 studies in ER literature6 studies in ER literature Propofol 19-48% resp depression on Propofol 19-48% resp depression on

supplemental 02supplemental 02 Ketamine 6% RD no O2Ketamine 6% RD no O2 Methohexital 48% RD on 02Methohexital 48% RD on 02

CapnographyCapnography

MAYBE*MAYBE* Deep sedation may require supplemental 02Deep sedation may require supplemental 02 Propofol sedation often deep or general Propofol sedation often deep or general Supplemental 02 may limit oximetry utilitySupplemental 02 may limit oximetry utility GREEN AND KRAUSS*GREEN AND KRAUSS* Krauss paid consultant for capnography companyKrauss paid consultant for capnography company Green – “Propofol not ready for prime time 1999”Green – “Propofol not ready for prime time 1999” Green– Propofol ready for prime time 2003 – Green– Propofol ready for prime time 2003 –

three* studies laterthree* studies later

Ancillary StaffAncillary Staff

Trained individual other than the practitioner Trained individual other than the practitioner should be monitoring patientshould be monitoring patient

CRHA monitored continuously during procedure CRHA monitored continuously during procedure by RN with or without RT by RN with or without RT

AirwayAirway OxygenationOxygenation Level of consciousnessLevel of consciousness PainPain General StatusGeneral Status

Ancillary StaffAncillary Staff

CRHA - CRHA - RN or LPN with or without RT RN or LPN with or without RT monitor immediately post procedure and monitor immediately post procedure and within 15 minutes the same parameters and within 15 minutes the same parameters and vital signsvital signs

MedicationsMedications

Combination of sedative/analgesic increase Combination of sedative/analgesic increase risk of complicationsrisk of complications

Efficacy of sedative alone unknown*Efficacy of sedative alone unknown* Propofol/methohexital use consistent with Propofol/methohexital use consistent with

deep or general anesthesiadeep or general anesthesia Etomidate not described but deep and Etomidate not described but deep and

general anesthesia commongeneral anesthesia common Ketamine difficult to classifyKetamine difficult to classify

Recovery Care Discharge Recovery Care Discharge CriteriaCriteria

D/C when able?D/C when able? ASA ---monitored until they are near baseline ASA ---monitored until they are near baseline

level of consciousness and are no longer at level of consciousness and are no longer at increased risk for cardiorespiratory depressionincreased risk for cardiorespiratory depression

ACEP return to pre procedure baselineACEP return to pre procedure baseline CAEP Airway patency, ventilation,cvs and CAEP Airway patency, ventilation,cvs and

hydration satisfactoryhydration satisfactory Level of consciousness returned to baselineLevel of consciousness returned to baseline Sit unassisted,* tolerate oral fluidsSit unassisted,* tolerate oral fluids

Recovery Care / Discharge Recovery Care / Discharge CriteriaCriteria

Insufficient literature on topicInsufficient literature on topic Based on post operative Aldrete* scoring Based on post operative Aldrete* scoring

systemsystem Activity respiration circulation Activity respiration circulation

consciousness and skin color max 10consciousness and skin color max 10 MPADSS– modified post anaesthetic scoreMPADSS– modified post anaesthetic score Vital signs ambulation nausea pain bleedingVital signs ambulation nausea pain bleeding

Recovery Care/Discharge Recovery Care/Discharge Criteria Criteria

““Street Fitness” or home readiness is also Street Fitness” or home readiness is also poorly definedpoorly defined

ACEP --no activity that requires ACEP --no activity that requires coordination for 24 hourscoordination for 24 hours

CAEP-- no coordination activity for 12 CAEP-- no coordination activity for 12 hours, no food or drink for two hours, hours, no food or drink for two hours, observe child closely for 8 hoursobserve child closely for 8 hours

Medication dependent/hospital dependentMedication dependent/hospital dependent

Recovery Care LiteratureRecovery Care Literature

When is a Patient Safe for Discharge After When is a Patient Safe for Discharge After Procedural Sedation ?Procedural Sedation ?Newman et al Annals of Newman et al Annals of Emergency Medicine 2003Emergency Medicine 2003

Prospective data base 2 years 1341 Prospective data base 2 years 1341 sedations adverse events 13.7%sedations adverse events 13.7%

Ketamine/midazolam fentanyl/midazolamKetamine/midazolam fentanyl/midazolam Conclusions– discharge from ED may be Conclusions– discharge from ED may be

safe ~30 minutes after final medicationsafe ~30 minutes after final medication

Recovery Care LiteratureRecovery Care Literature

No discharge criteria in placeNo discharge criteria in place Follow up patients poor 64%Follow up patients poor 64% Serious adverse effects occurred median 2 Serious adverse effects occurred median 2

minutes post final med but up to 40 minutes minutes post final med but up to 40 minutes post medpost med

Clearly cannot generalize dataClearly cannot generalize data

Guidelines/Anaesthesia?Guidelines/Anaesthesia?

Preprocedure assessmentPreprocedure assessment Pre procedure preparation fastingPre procedure preparation fasting Monitoring people equipmentMonitoring people equipment Drug selection- sedation depthDrug selection- sedation depth Post procedure carePost procedure care

Is Etomidate Safe for ER Is Etomidate Safe for ER Induction?Induction?

UnknownUnknown Adrenal suppression—1983 increased Adrenal suppression—1983 increased

mortality in ICU 40% with etomidate mortality in ICU 40% with etomidate infusion cause infection postulated to be infusion cause infection postulated to be adrenal suppressionadrenal suppression

Multiple studies confirm adrenal Multiple studies confirm adrenal suppression in infusions and single dosessuppression in infusions and single doses

Clinical implication unclearClinical implication unclear

Etomidate literatureEtomidate literature

Adrenocortical Dysfunction following Adrenocortical Dysfunction following Etomidate Induction in EREtomidate Induction in ER Schenarts et al Academic Schenarts et al Academic emergency medicine 2001emergency medicine 2001

Prospective randomized controlled n=18Prospective randomized controlled n=18 Etomidate vs midazolam RSI measuring Etomidate vs midazolam RSI measuring

cortisol response to CST testing 4-24 hourscortisol response to CST testing 4-24 hours Conclusions: etomidate in ED RSI results Conclusions: etomidate in ED RSI results

in adrenocortical dysfunction which appears in adrenocortical dysfunction which appears to resolve in 12 hoursto resolve in 12 hours

Etomidate literatureEtomidate literature

Important study but serious flawsImportant study but serious flaws Data collection errors methodology Data collection errors methodology

questionablequestionable Reporting of data concerningReporting of data concerning Of note: hours intubated 68.6 etomidate Of note: hours intubated 68.6 etomidate

28.4 midazolam ----hours in ICU 96.8 28.4 midazolam ----hours in ICU 96.8 etomidate ,42 midazolametomidate ,42 midazolam

Leaves question unansweredLeaves question unanswered

Etomidate LiteratureEtomidate Literature

NEAR study-- 60% intubations etomidate NEAR study-- 60% intubations etomidate suggesting higher dose for successsuggesting higher dose for success

Need another study to address impact of Need another study to address impact of etomidate in ER on ICU outcomeetomidate in ER on ICU outcome

Adrenal suppression increased mortality in Adrenal suppression increased mortality in adult ICU patients and increased adult ICU patients and increased vasopressor use in pediatric patientsvasopressor use in pediatric patients

Etomidate LiteratureEtomidate Literature

PROCEDURAL SEDATION 6 studies 5 PROCEDURAL SEDATION 6 studies 5 ERER

Mainly retrospective small numbersMainly retrospective small numbers Myoclonus 2-20%Myoclonus 2-20% Vomiting 2-10%Vomiting 2-10% Hypoxia 10%*Hypoxia 10%* Hypotension 2-5%Hypotension 2-5% Deep sedation was frequent when recordedDeep sedation was frequent when recorded

IS PROPOFOL SAFE in IS PROPOFOL SAFE in CHILDREN?CHILDREN?

Propofol infusion syndrome FDA health Propofol infusion syndrome FDA health warning 2001*warning 2001*

CMAJ 2002 Wooltorton significant harm CMAJ 2002 Wooltorton significant harm can come from off-label use of agents can come from off-label use of agents whose pediatric safety profile is whose pediatric safety profile is incomplete*incomplete*

Large dose propofol affects cerebral Large dose propofol affects cerebral autoregulation --caution in head injured autoregulation --caution in head injured patients patients Anesth Analg 2003Anesth Analg 2003

Safety of Propofol in Pediatric Safety of Propofol in Pediatric Procedural SedationProcedural Sedation

5 published ER studies*5 published ER studies* Propofol hypoxia 5%-30%**Propofol hypoxia 5%-30%** Hypotension 5%-30%**Hypotension 5%-30%** Troubling MethodologyTroubling Methodology Supplemental oxygenSupplemental oxygen Blood pressure measurement skewedBlood pressure measurement skewed Adverse events altered definitionAdverse events altered definition

Propofol LiteraturePropofol Literature

Propofol for Procedural Sedation in Propofol for Procedural Sedation in Children in the ERChildren in the ER Basset et al Annals of ER 2003 Basset et al Annals of ER 2003

Consecutive case series n=392 Consecutive case series n=392 92% transient hypotension92% transient hypotension 5% hypoxia 3% jaw thrust 1%bvm5% hypoxia 3% jaw thrust 1%bvm Conclusion: efficacious no adverse Conclusion: efficacious no adverse

outcomesoutcomes

Propofol LiteraturePropofol Literature

Preoxygenation 10L/minPreoxygenation 10L/min Blood pressure change = post sedation Blood pressure change = post sedation

blood pressure- minimumblood pressure- minimum ~80 patients had blood pressure drop of >20 ~80 patients had blood pressure drop of >20

six required iv fluidssix required iv fluids ~80 patients dropped 02sat>5% after ~80 patients dropped 02sat>5% after

preoxygenationpreoxygenation Four member team Four member team

Propofol literaturePropofol literature

Propofol vs Ketamine in pediatric critical Propofol vs Ketamine in pediatric critical care care Vardi et al Critical Care Medicine 2002Vardi et al Critical Care Medicine 2002

Prospective randomized n=105Prospective randomized n=105 Propofol vs Ketamine midazolam fentanylPropofol vs Ketamine midazolam fentanyl Propofol 2.5mg/kg vs Ketamine 2.5mg/kg/ Propofol 2.5mg/kg vs Ketamine 2.5mg/kg/

midazolam 0.1mg/kg fentanyl 2ug/kgmidazolam 0.1mg/kg fentanyl 2ug/kg SIGNIFICANT DIFFERENCE ADVERSE SIGNIFICANT DIFFERENCE ADVERSE

EFFECTS REQUIRING INTERVENTION EFFECTS REQUIRING INTERVENTION WITH PROPOFOLWITH PROPOFOL

Propofol SafetyPropofol Safety

Clearly there are safer drugs than propofolClearly there are safer drugs than propofol Does a little hypoxia and or hypotension in Does a little hypoxia and or hypotension in

a monitored setting give rise to concerns if a monitored setting give rise to concerns if the drug is efficacious and efficient?the drug is efficacious and efficient?

Proceed with cautionProceed with caution

Is Ketamine Safe in Head Injured Is Ketamine Safe in Head Injured Patients?Patients?

MAYBEMAYBE Historically ketamine was used for Historically ketamine was used for

neurodiagnostic sedations in hundreds of neurodiagnostic sedations in hundreds of patients in 60’s and 70’s with no sequelaepatients in 60’s and 70’s with no sequelae

1972-1974 small case series with varying 1972-1974 small case series with varying doses of ketamine and variable monitoring doses of ketamine and variable monitoring devices variable ICP demonstrate elevation devices variable ICP demonstrate elevation in ICP mean~increase 30 no sequelaein ICP mean~increase 30 no sequelae

Ketamine Head InjuryKetamine Head Injury

Case series during similar era, similar Case series during similar era, similar method and design demonstrate that method and design demonstrate that intubation, inhalational anesthetics and intubation, inhalational anesthetics and succinylcholine lead to ~increase ICP 25succinylcholine lead to ~increase ICP 25

Clinical implications of brief rise in ICP in Clinical implications of brief rise in ICP in already elevated ICP was and still unclearalready elevated ICP was and still unclear

Ketamine Head InjuryKetamine Head Injury

1974-2003 small prospective randomized studies 1974-2003 small prospective randomized studies done with intravenous ketamine for sedation on done with intravenous ketamine for sedation on ventilated head injured patientsventilated head injured patients

No change or significant improvement in ICPNo change or significant improvement in ICP No change in cerebral perfusion pressureNo change in cerebral perfusion pressure Decrease in cerebral blood flow velocityDecrease in cerebral blood flow velocity Decrease in EEG powerDecrease in EEG power Maintains cerebral autoregulationMaintains cerebral autoregulation

Ketamine Head InjuryKetamine Head Injury

Ketamine effects on cerebral Ketamine effects on cerebral hemodynamics poorly understoodhemodynamics poorly understood

May or may not increase regional cerebral May or may not increase regional cerebral blood flow but minimal effects on blood flow but minimal effects on metabolismmetabolism

Increases neuronal activity Increases neuronal activity May have a neuroprotective effect as a May have a neuroprotective effect as a

NMDA antagonistNMDA antagonist S+isomer may have less cerebral effectsS+isomer may have less cerebral effects

Ketamine Head InjuryKetamine Head Injury

Maybe Maybe It is all about Numbers and not OutcomeIt is all about Numbers and not Outcome Are transient decreases in MAP and CPP Are transient decreases in MAP and CPP

with thiopentothal or midazolam worse or with thiopentothal or midazolam worse or better than transient increases in MAP and better than transient increases in MAP and ICP with ketamine?ICP with ketamine?

Who Cares? Patient profileWho Cares? Patient profile

Controversies Sedation and Controversies Sedation and Induction in ERInduction in ER

Multiple medication optionsMultiple medication options Significant potential adverse effects with Significant potential adverse effects with

most meds but few significant most meds but few significant complicationscomplications

Literature relatively weak in design and Literature relatively weak in design and numbers with multiple manipulations of numbers with multiple manipulations of datadata

Significant pharmaceutical money at stakeSignificant pharmaceutical money at stake

ControversiesControversies

Safety is paramount*-- enhance with drug Safety is paramount*-- enhance with drug knowledge, preprocedure assessment, monitoring knowledge, preprocedure assessment, monitoring and discharge criteriaand discharge criteria

Efficacy is important but sedation depth is poorly Efficacy is important but sedation depth is poorly defined and measured defined and measured

Efficiency is important but cannot preclude safety Efficiency is important but cannot preclude safety and efficacyand efficacy

Medicolegal concerns necessitate improved Medicolegal concerns necessitate improved documentationdocumentation

Ideal Drug? Ideal Drug?

ControversiesControversies

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