1. Controversies in Procedural Sedation and Induction in ER February 2004

2. Controversies REVIEW OF ANESTHESIA GUIDELINES REVIEW OF ANESTHESIA GUIDELINES IS ETOMIDATE SAFE FOR ER INDUCTION? IS ETOMIDATE SAFE FOR ER INDUCTION? IS PROPOFOL SAFE IN CHILDREN? IS PROPOFOL SAFE IN CHILDREN? IS KETAMINE SAFE IN HEAD INJURED PATIENTS? IS KETAMINE SAFE IN HEAD INJURED PATIENTS?

3. ANESTHESIA GUIDELINES PRACTICE GUIDELINES FOR SEDATION AND ANALGESIA BY NON- ANESTHESIOLOGISTS ANESTHESIOLGY 2002 PRACTICE GUIDELINES FOR SEDATION AND ANALGESIA BY NON- ANESTHESIOLOGISTS ANESTHESIOLGY 2002 GUIDELINES FOR MONITORING AND MANAGEMENT OF PEDIATRIC PATIENTS DURING AND AFTER SEDATION –ADDENDUM PEDIATRICS 2002 GUIDELINES FOR MONITORING AND MANAGEMENT OF PEDIATRIC PATIENTS DURING AND AFTER SEDATION –ADDENDUM PEDIATRICS 2002

4. ANESTHESIA GUIDELINES ASA 2002 ASA 2002 AAP 2002 AAP 2002 EVIDENCE BASED CONSENSUS OPINION TASK FORCE EVIDENCE BASED CONSENSUS OPINION TASK FORCE CAEP 1999 CAEP 1999 ACEP 1998 ACEP 1998

5. PEDIATRIC ADDENDUM DOCUMENTED PRESEDATION MEDICAL EVALUATION DOCUMENTED PRESEDATION MEDICAL EVALUATION APPROPRIATE FASTING INTERVAL APPROPRIATE FASTING INTERVAL SKILLED PERSONNEL SKILLED PERSONNEL PULSE OXIMETRY PULSE OXIMETRY ASSIGNED MONITORING INDIVIDUAL ASSIGNED MONITORING INDIVIDUAL SPECIFIC DISCHARGE CRITERIA SPECIFIC DISCHARGE CRITERIA

6. ASA PRACTICE GUIDELINES DEFINTION SEDATION DEPTH DEFINTION SEDATION DEPTH PRE PROCEDURE ASSESSMENT PRE PROCEDURE ASSESSMENT PRE PROCEDURE FASTING PRE PROCEDURE FASTING MONITORING / CAPNOGRAPHY MONITORING / CAPNOGRAPHY ANCILLARY STAFF ANCILLARY STAFF MEDICATIONS MEDICATIONS RECOVERY CARE/DISCHARGE CRITERIA RECOVERY CARE/DISCHARGE CRITERIA

7. LOCAL ANESTHESIA CONCERNS GENERAL ANESTHESIA IN ER GENERAL ANESTHESIA IN ER POOR DOCUMENTATION POOR DOCUMENTATION PRE PROCEDURE ASSESSMENT PRE PROCEDURE ASSESSMENT POST PROCEDURE RECOVERY POST PROCEDURE RECOVERY DISCHARGE CRITERIA DISCHARGE CRITERIA EDUCATIONAL PROCESS EDUCATIONAL PROCESS

8. DEPTH OF SEDATION SedationResponseAirwayVentCVS Moderatepurposenormalnormalnormal DeepRepeatedpainfulPossibleintervenePossibleabnormalUsuallynormal GeneralanesthNoresponseOfteninterveneFrequentabnormalMaybeabnormal

9. Sedation Depth Conscious Sedation removed Conscious Sedation removed Dissociative Sedation not classified Dissociative Sedation not classified All sedatives and narcotics can produce all levels of sedation,some are more likely to induce deep or general anesthesia All sedatives and narcotics can produce all levels of sedation,some are more likely to induce deep or general anesthesia Deep and general anesthesia are more likely to be associated with adverse reactions Deep and general anesthesia are more likely to be associated with adverse reactions Sedation depth difficult to measure Sedation depth difficult to measure

10. PRE PROCEDURE EVALUATION Guided RiskAssessment Tool HOFFMAN PEDS 02 Guided RiskAssessment Tool HOFFMAN PEDS 02 Snoring, Stridor Sleep apnea Snoring, Stridor Sleep apnea Airway abnormalities Airway abnormalities Vomiting, bowel obstruction Vomiting, bowel obstruction Gastroesophageal reflux Gastroesophageal reflux ASA class ASA class Sedation Failure Sedation Failure NPO status NPO status

11. PRE PROCEDURE FASTING REQUIREMENTS ASA GUIDELINES ASA GUIDELINES Liquids 2 hours Liquids 2 hours Breast milk 4 hours Breast milk 4 hours Solids 6 hours Solids 6 hours NO SCIENTIFIC EVIDENCE TO SUPPORT THIS CONSENSUS OPINION NO SCIENTIFIC EVIDENCE TO SUPPORT THIS CONSENSUS OPINION TRACHEA and ESOPHAGEAL PROCEDURES NOT ROUTINE IN ER TRACHEA and ESOPHAGEAL PROCEDURES NOT ROUTINE IN ER

12. PRE PROCEDURAL FASTING ASPIRATION RISK ASPIRATION RISK NO Published aspiration in ER> 30 years NO Published aspiration in ER> 30 years Risk of aspiration ~1/895 emergency surgery and ~1/3500 surgery Risk of aspiration ~1/895 emergency surgery and ~1/3500 surgery Two thirds aspiration during intubation Two thirds aspiration during intubation Increased incidence of sedation failures with prolonged fasting times Increased incidence of sedation failures with prolonged fasting times

13. FASTING LITERATURE Pre procedural fasting adverse events ER Agarwal et al Annals of Emergency Medicine 2003 Pre procedural fasting adverse events ER Agarwal et al Annals of Emergency Medicine 2003 Pediatrics prospective case series n=905 Pediatrics prospective case series n=905 Adverse events minor 8.1%* incidence in compliant and 6.9%* in noncompliant Adverse events minor 8.1%* incidence in compliant and 6.9%* in noncompliant Emesis 1.5% Emesis 1.5% Medications ketamine/midazolam fentanyl/midazolam Medications ketamine/midazolam fentanyl/midazolam

14. FASTING LITERATURE Median fasting duration solids 9.6 *hours vs 5.2 hours non compliant Median fasting duration solids 9.6 *hours vs 5.2 hours non compliant Median fasting duration clear liquids 8.5 hours vs 4.7* hours non compliant Median fasting duration clear liquids 8.5 hours vs 4.7* hours non compliant CONCLUSION There was no association between preprocedural fasting state and adverse events CONCLUSION There was no association between preprocedural fasting state and adverse events ????? What? ????? What?

15. Preprocedural Fasting ACEP recent food intake is not a contraindication for administering PSA but should be considered in choosing the depth and target level of sedation ACEP recent food intake is not a contraindication for administering PSA but should be considered in choosing the depth and target level of sedation CAEP Urgency of procedure and desired depth of sedation should be weighed against the risk associated with inadequate fasting CAEP Urgency of procedure and desired depth of sedation should be weighed against the risk associated with inadequate fasting ASA potential for aspiration must be considered in determining target sedation level, or whether to delay or protect by intubation ASA potential for aspiration must be considered in determining target sedation level, or whether to delay or protect by intubation ??? ???

16. MONITORING Level of consciousness Level of consciousness Oxygenation Oxygenation Hemodynamics Hemodynamics Ventilation* capnography Ventilation* capnography

19. Ventilation Capnography ASA-- capnography may decrease risks during deep sedation ASA-- capnography may decrease risks during deep sedation Capnography may decrease risks during moderate and deep sedation when patient physically separated from caregiver Capnography may decrease risks during moderate and deep sedation when patient physically separated from caregiver Supplemental oxygen decreases patient risk during deep sedation Supplemental oxygen decreases patient risk during deep sedation

20. Capnography Measurement of endtidal CO2 infrared spectroscopy nasal cannulae Measurement of endtidal CO2 infrared spectroscopy nasal cannulae Not as accurate as in intubated patients Not as accurate as in intubated patients No evidence to suggest that it will reduce complications but may alert to subclinical respiratory depression No evidence to suggest that it will reduce complications but may alert to subclinical respiratory depression Respiratory depression- ETCO>50, increase >10 from baseline, absent waveforem Respiratory depression- ETCO>50, increase >10 from baseline, absent waveforem

21. Capnography Literature 6 studies in ER literature 6 studies in ER literature Propofol 19-48% resp depression on supplemental 02 Propofol 19-48% resp depression on supplemental 02 Ketamine 6% RD no O2 Ketamine 6% RD no O2 Methohexital 48% RD on 02 Methohexital 48% RD on 02

22. Capnography MAYBE* MAYBE* Deep sedation may require supplemental 02 Deep sedation may require supplemental 02 Propofol sedation often deep or general Propofol sedation often deep or general Supplemental 02 may limit oximetry utility Supplemental 02 may limit oximetry utility GREEN AND KRAUSS* GREEN AND KRAUSS* Krauss paid consultant for capnography company Krauss 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 – three* studies later Green– Propofol ready for prime time 2003 – three* studies later

23. Ancillary Staff Trained individual other than the practitioner should be monitoring patient Trained individual other than the practitioner should be monitoring patient CRHA monitored continuously during procedure by RN with or without RT CRHA monitored continuously during procedure by RN with or without RT Airway Airway Oxygenation Oxygenation Level of consciousness Level of consciousness Pain Pain General Status General Status

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

25. Medications Combination of sedative/analgesic increase risk of complications Combination of sedative/analgesic increase risk of complications Efficacy of sedative alone unknown* Efficacy of sedative alone unknown* Propofol/methohexital use consistent with deep or general anesthesia Propofol/methohexital use consistent with deep or general anesthesia Etomidate not described but deep and general anesthesia common Etomidate not described but deep and general anesthesia common Ketamine difficult to classify Ketamine difficult to classify

26. Recovery Care Discharge Criteria D/C when able? D/C when able? ASA ---monitored until they are near baseline level of consciousness and are no longer at increased risk for cardiorespiratory depression ASA ---monitored until they are near baseline level of consciousness and are no longer at increased risk for cardiorespiratory depression ACEP return to pre procedure baseline ACEP return to pre procedure baseline CAEP Airway patency, ventilation,cvs and hydration satisfactory CAEP Airway patency, ventilation,cvs and hydration satisfactory Level of consciousness returned to baseline Level of consciousness returned to baseline Sit unassisted,* tolerate oral fluids Sit unassisted,* tolerate oral fluids

27. Recovery Care / Discharge Criteria Insufficient literature on topic Insufficient literature on topic Based on post operative Aldrete* scoring system Based on post operative Aldrete* scoring system Activity respiration circulation consciousness and skin color max 10 Activity respiration circulation consciousness and skin color max 10 MPADSS– modified post anaesthetic score MPADSS– modified post anaesthetic score Vital signs ambulation nausea pain bleeding Vital signs ambulation nausea pain bleeding

28. Recovery Care/Discharge Criteria “Street Fitness” or home readiness is also poorly defined “Street Fitness” or home readiness is also poorly defined ACEP --no activity that requires coordination for 24 hours ACEP --no activity that requires coordination for 24 hours CAEP-- no coordination activity for 12 hours, no food or drink for two hours, observe child closely for 8 hours CAEP-- no coordination activity for 12 hours, no food or drink for two hours, observe child closely for 8 hours Medication dependent/hospital dependent Medication dependent/hospital dependent

29. Recovery Care Literature When is a Patient Safe for Discharge After Procedural Sedation ? Newman et al Annals of Emergency Medicine 2003 When is a Patient Safe for Discharge After Procedural Sedation ? Newman et al Annals of Emergency Medicine 2003 Prospective data base 2 years 1341 sedations adverse events 13.7% Prospective data base 2 years 1341 sedations adverse events 13.7% Ketamine/midazolam fentanyl/midazolam Ketamine/midazolam fentanyl/midazolam Conclusions– discharge from ED may be safe ~30 minutes after final medication Conclusions– discharge from ED may be safe ~30 minutes after final medication

30. Recovery Care Literature No discharge criteria in place No discharge criteria in place Follow up patients poor 64% Follow up patients poor 64% Serious adverse effects occurred median 2 minutes post final med but up to 40 minutes post med Serious adverse effects occurred median 2 minutes post final med but up to 40 minutes post med Clearly cannot generalize data Clearly cannot generalize data

31. Guidelines/Anaesthesia? Preprocedure assessment Preprocedure assessment Pre procedure preparation fasting Pre procedure preparation fasting Monitoring people equipment Monitoring people equipment Drug selection- sedation depth Drug selection- sedation depth Post procedure care Post procedure care

32. Is Etomidate Safe for ER Induction? Unknown Unknown Adrenal suppression—1983 increased mortality in ICU 40% with etomidate infusion cause infection postulated to be adrenal suppression Adrenal suppression—1983 increased mortality in ICU 40% with etomidate infusion cause infection postulated to be adrenal suppression Multiple studies confirm adrenal suppression in infusions and single doses Multiple studies confirm adrenal suppression in infusions and single doses Clinical implication unclear Clinical implication unclear

33. Etomidate literature Adrenocortical Dysfunction following Etomidate Induction in ER Schenarts et al Academic emergency medicine 2001 Prospective randomized controlled n=18 Prospective randomized controlled n=18 Etomidate vs midazolam RSI measuring cortisol response to CST testing 4-24 hours Etomidate vs midazolam RSI measuring cortisol response to CST testing 4-24 hours Conclusions: etomidate in ED RSI results in adrenocortical dysfunction which appears to resolve in 12 hours Conclusions: etomidate in ED RSI results in adrenocortical dysfunction which appears to resolve in 12 hours

34. Etomidate literature Important study but serious flaws Important study but serious flaws Data collection errors methodology questionable Data collection errors methodology questionable Reporting of data concerning Reporting of data concerning Of note: hours intubated 68.6 etomidate 28.4 midazolam ----hours in ICU 96.8 etomidate,42 midazolam Of note: hours intubated 68.6 etomidate 28.4 midazolam ----hours in ICU 96.8 etomidate,42 midazolam Leaves question unanswered Leaves question unanswered

35. Etomidate Literature NEAR study-- 60% intubations etomidate suggesting higher dose for success NEAR study-- 60% intubations etomidate suggesting higher dose for success Need another study to address impact of etomidate in ER on ICU outcome Need another study to address impact of etomidate in ER on ICU outcome Adrenal suppression increased mortality in adult ICU patients and increased vasopressor use in pediatric patients Adrenal suppression increased mortality in adult ICU patients and increased vasopressor use in pediatric patients

36. Etomidate Literature PROCEDURAL SEDATION 6 studies 5 ER PROCEDURAL SEDATION 6 studies 5 ER Mainly retrospective small numbers Mainly 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 recorded Deep sedation was frequent when recorded

37. IS PROPOFOL SAFE in CHILDREN? Propofol infusion syndrome FDA health warning 2001* Propofol infusion syndrome FDA health warning 2001* CMAJ 2002 Wooltorton significant harm can come from off-label use of agents whose pediatric safety profile is incomplete* CMAJ 2002 Wooltorton significant harm can come from off-label use of agents whose pediatric safety profile is incomplete* Large dose propofol affects cerebral autoregulation --caution in head injured patients Anesth Analg 2003 Large dose propofol affects cerebral autoregulation --caution in head injured patients Anesth Analg 2003

38. Safety of Propofol in Pediatric Procedural Sedation 5 published ER studies* 5 published ER studies* Propofol hypoxia 5%-30%** Propofol hypoxia 5%-30%** Hypotension 5%-30%** Hypotension 5%-30%** Troubling Methodology Troubling Methodology Supplemental oxygen Supplemental oxygen Blood pressure measurement skewed Blood pressure measurement skewed Adverse events altered definition Adverse events altered definition

39. Propofol Literature Propofol for Procedural Sedation in Children in the ER Basset et al Annals of ER 2003 Propofol for Procedural Sedation in Children in the ER Basset et al Annals of ER 2003 Consecutive case series n=392 Consecutive case series n=392 92% transient hypotension 92% transient hypotension 5% hypoxia 3% jaw thrust 1%bvm 5% hypoxia 3% jaw thrust 1%bvm Conclusion: efficacious no adverse outcomes Conclusion: efficacious no adverse outcomes

40. Propofol Literature Preoxygenation 10L/min Preoxygenation 10L/min Blood pressure change = post sedation blood pressure- minimum Blood pressure change = post sedation blood pressure- minimum ~80 patients had blood pressure drop of >20 six required iv fluids ~80 patients had blood pressure drop of >20 six required iv fluids ~80 patients dropped 02sat>5% after preoxygenation ~80 patients dropped 02sat>5% after preoxygenation Four member team Four member team

41. Propofol literature Propofol vs Ketamine in pediatric critical care Vardi et al Critical Care Medicine 2002 Propofol vs Ketamine in pediatric critical care Vardi et al Critical Care Medicine 2002 Prospective randomized n=105 Prospective randomized n=105 Propofol vs Ketamine midazolam fentanyl Propofol vs Ketamine midazolam fentanyl Propofol 2.5mg/kg vs Ketamine 2.5mg/kg/ midazolam 0.1mg/kg fentanyl 2ug/kg Propofol 2.5mg/kg vs Ketamine 2.5mg/kg/ midazolam 0.1mg/kg fentanyl 2ug/kg SIGNIFICANT DIFFERENCE ADVERSE EFFECTS REQUIRING INTERVENTION WITH PROPOFOL SIGNIFICANT DIFFERENCE ADVERSE EFFECTS REQUIRING INTERVENTION WITH PROPOFOL

42. Propofol Safety Clearly there are safer drugs than propofol Clearly there are safer drugs than propofol Does a little hypoxia and or hypotension in a monitored setting give rise to concerns if the drug is efficacious and efficient? Does a little hypoxia and or hypotension in a monitored setting give rise to concerns if the drug is efficacious and efficient? Proceed with caution Proceed with caution

43. Is Ketamine Safe in Head Injured Patients? MAYBE MAYBE Historically ketamine was used for neurodiagnostic sedations in hundreds of patients in 60’s and 70’s with no sequelae Historically ketamine was used for neurodiagnostic sedations in hundreds of patients in 60’s and 70’s with no sequelae 1972-1974 small case series with varying doses of ketamine and variable monitoring devices variable ICP demonstrate elevation in ICP mean~increase 30 no sequelae 1972-1974 small case series with varying doses of ketamine and variable monitoring devices variable ICP demonstrate elevation in ICP mean~increase 30 no sequelae

44. Ketamine Head Injury Case series during similar era, similar method and design demonstrate that intubation, inhalational anesthetics and succinylcholine lead to ~increase ICP 25 Clinical implications of brief rise in ICP in already elevated ICP was and still unclear

45. Ketamine Head Injury 1974-2003 small prospective randomized studies done with intravenous ketamine for sedation on ventilated head injured patients 1974-2003 small prospective randomized studies done with intravenous ketamine for sedation on ventilated head injured patients No change or significant improvement in ICP No change or significant improvement in ICP No change in cerebral perfusion pressure No change in cerebral perfusion pressure Decrease in cerebral blood flow velocity Decrease in cerebral blood flow velocity Decrease in EEG power Decrease in EEG power Maintains cerebral autoregulation Maintains cerebral autoregulation

46. Ketamine Head Injury Ketamine effects on cerebral hemodynamics poorly understood Ketamine effects on cerebral hemodynamics poorly understood May or may not increase regional cerebral blood flow but minimal effects on metabolism May or may not increase regional cerebral blood flow but minimal effects on metabolism Increases neuronal activity Increases neuronal activity May have a neuroprotective effect as a NMDA antagonist May have a neuroprotective effect as a NMDA antagonist S+isomer may have less cerebral effects S+isomer may have less cerebral effects

47. Ketamine Head Injury Maybe Maybe It is all about Numbers and not Outcome It is all about Numbers and not Outcome Are transient decreases in MAP and CPP with thiopentothal or midazolam worse or better than transient increases in MAP and ICP with ketamine? Are transient decreases in MAP and CPP with thiopentothal or midazolam worse or better than transient increases in MAP and ICP with ketamine? Who Cares? Patient profile Who Cares? Patient profile

48. Controversies Sedation and Induction in ER Multiple medication options Multiple medication options Significant potential adverse effects with most meds but few significant complications Significant potential adverse effects with most meds but few significant complications Literature relatively weak in design and numbers with multiple manipulations of data Literature relatively weak in design and numbers with multiple manipulations of data Significant pharmaceutical money at stake Significant pharmaceutical money at stake

49. Controversies Safety is paramount*-- enhance with drug knowledge, preprocedure assessment, monitoring and discharge criteria Safety is paramount*-- enhance with drug knowledge, preprocedure assessment, monitoring and discharge criteria Efficacy is important but sedation depth is poorly defined and measured Efficacy is important but sedation depth is poorly defined and measured Efficiency is important but cannot preclude safety and efficacy Efficiency is important but cannot preclude safety and efficacy Medicolegal concerns necessitate improved documentation Medicolegal concerns necessitate improved documentation Ideal Drug? Ideal Drug?

50. Controversies Controversies ??????