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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
??????
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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