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Controversies in Procedural Sedation and Induction in ER February 2004 Controversies REVIEW OF ANESTHESIA GUIDELINES IS ETOMIDATE SAFE FOR ER INDUCTION? IS PROPOFOL SAFE IN CHILDREN? IS KETAMINE SAFE IN HEAD INJURED PATIENTS? ANESTHESIA GUIDELINES PRACTICE GUIDELINES FOR SEDATION AND ANALGESIA BY NONANESTHESIOLOGISTS ANESTHESIOLGY 2002 GUIDELINES FOR MONITORING AND MANAGEMENT OF PEDIATRIC PATIENTS DURING AND AFTER SEDATION –ADDENDUM PEDIATRICS 2002 ANESTHESIA GUIDELINES ASA 2002 AAP 2002 EVIDENCE BASED CONSENSUS OPINION TASK FORCE CAEP 1999 ACEP 1998 PEDIATRIC ADDENDUM DOCUMENTED PRESEDATION MEDICAL EVALUATION APPROPRIATE FASTING INTERVAL SKILLED PERSONNEL PULSE OXIMETRY ASSIGNED MONITORING INDIVIDUAL SPECIFIC DISCHARGE CRITERIA ASA PRACTICE GUIDELINES DEFINTION SEDATION DEPTH PRE PROCEDURE ASSESSMENT PRE PROCEDURE FASTING MONITORING / CAPNOGRAPHY ANCILLARY STAFF MEDICATIONS RECOVERY CARE/DISCHARGE CRITERIA LOCAL ANESTHESIA CONCERNS GENERAL ANESTHESIA IN ER POOR DOCUMENTATION PRE PROCEDURE ASSESSMENT POST PROCEDURE RECOVERY DISCHARGE CRITERIA EDUCATIONAL PROCESS DEPTH OF SEDATION Sedation Response Airway Vent CVS Moderate purpose normal normal normal Deep Repeated Possible Possible Usually painful intervene abnormal normal General anesth No Often Frequent Maybe response intervene abnormal abnormal Sedation Depth Conscious Sedation removed Dissociative Sedation not classified 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 Sedation depth difficult to measure PRE PROCEDURE EVALUATION Guided RiskAssessment Tool Snoring, Stridor Sleep apnea Airway abnormalities Vomiting, bowel obstruction Gastroesophageal reflux ASA class Sedation Failure NPO status HOFFMAN PEDS 02 PRE PROCEDURE FASTING REQUIREMENTS ASA GUIDELINES Liquids 2 hours Breast milk 4 hours Solids 6 hours NO SCIENTIFIC EVIDENCE TO SUPPORT THIS CONSENSUS OPINION TRACHEA and ESOPHAGEAL PROCEDURES NOT ROUTINE IN ER PRE PROCEDURAL FASTING ASPIRATION RISK NO Published aspiration in ER> 30 years Risk of aspiration ~1/895 emergency surgery and ~1/3500 surgery Two thirds aspiration during intubation Increased incidence of sedation failures with prolonged fasting times FASTING LITERATURE Pre procedural fasting adverse events ER Agarwal et al Annals of Emergency Medicine 2003 Pediatrics prospective case series n=905 Adverse events minor 8.1%* incidence in compliant and 6.9%* in noncompliant Emesis 1.5% Medications ketamine/midazolam fentanyl/midazolam FASTING LITERATURE 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 CONCLUSION There was no association between preprocedural fasting state and adverse events ????? What? 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 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 ??? MONITORING Level of consciousness Oxygenation Hemodynamics Ventilation* capnography Ventilation Capnography ASA-- capnography may decrease risks during deep sedation Capnography may decrease risks during moderate and deep sedation when patient physically separated from caregiver Supplemental oxygen decreases patient risk during deep sedation Capnography Measurement of endtidal CO2 infrared spectroscopy nasal cannulae Not as accurate as in intubated patients 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 Capnography Literature 6 studies in ER literature Propofol 19-48% resp depression on supplemental 02 Ketamine 6% RD no O2 Methohexital 48% RD on 02 Capnography MAYBE* Deep sedation may require supplemental 02 Propofol sedation often deep or general Supplemental 02 may limit oximetry utility GREEN AND KRAUSS* Krauss paid consultant for capnography company Green – “Propofol not ready for prime time 1999” Green– Propofol ready for prime time 2003 – three* studies later Ancillary Staff Trained individual other than the practitioner should be monitoring patient CRHA monitored continuously during procedure by RN with or without RT Airway Oxygenation Level of consciousness Pain General Status Ancillary Staff CRHA - RN or LPN with or without RT monitor immediately post procedure and within 15 minutes the same parameters and vital signs Medications Combination of sedative/analgesic increase risk of complications Efficacy of sedative alone unknown* Propofol/methohexital use consistent with deep or general anesthesia Etomidate not described but deep and general anesthesia common Ketamine difficult to classify Recovery Care Discharge Criteria D/C when able? 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 CAEP Airway patency, ventilation,cvs and hydration satisfactory Level of consciousness returned to baseline Sit unassisted,* tolerate oral fluids Recovery Care / Discharge Criteria Insufficient literature on topic Based on post operative Aldrete* scoring system Activity respiration circulation consciousness and skin color max 10 MPADSS– modified post anaesthetic score Vital signs ambulation nausea pain bleeding Recovery Care/Discharge Criteria “Street Fitness” or home readiness is also poorly defined 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 Medication dependent/hospital dependent Recovery Care Literature 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% Ketamine/midazolam fentanyl/midazolam Conclusions– discharge from ED may be safe ~30 minutes after final medication Recovery Care Literature No discharge criteria in place Follow up patients poor 64% Serious adverse effects occurred median 2 minutes post final med but up to 40 minutes post med Clearly cannot generalize data Guidelines/Anaesthesia? Preprocedure assessment Pre procedure preparation fasting Monitoring people equipment Drug selection- sedation depth Post procedure care Is Etomidate Safe for ER Induction? Unknown 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 Clinical implication unclear Etomidate literature Adrenocortical Dysfunction following Etomidate Induction in ER Schenarts et al Academic emergency medicine 2001 Prospective randomized controlled n=18 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 Etomidate literature Important study but serious flaws Data collection errors methodology questionable Reporting of data concerning Of note: hours intubated 68.6 etomidate 28.4 midazolam ----hours in ICU 96.8 etomidate ,42 midazolam Leaves question unanswered Etomidate Literature NEAR study-- 60% intubations etomidate suggesting higher dose for success 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 Etomidate Literature PROCEDURAL SEDATION 6 studies 5 ER Mainly retrospective small numbers Myoclonus 2-20% Vomiting 2-10% Hypoxia 10%* Hypotension 2-5% Deep sedation was frequent when recorded IS PROPOFOL SAFE in CHILDREN? 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* Large dose propofol affects cerebral autoregulation --caution in head injured patients Anesth Analg 2003 Safety of Propofol in Pediatric Procedural Sedation 5 published ER studies* Propofol hypoxia 5%-30%** Hypotension 5%-30%** Troubling Methodology Supplemental oxygen Blood pressure measurement skewed Adverse events altered definition Propofol Literature Propofol for Procedural Sedation in Children in the ER Basset et al Annals of ER 2003 Consecutive case series n=392 92% transient hypotension 5% hypoxia 3% jaw thrust 1%bvm Conclusion: efficacious no adverse outcomes Propofol Literature Preoxygenation 10L/min Blood pressure change = post sedation blood pressure- minimum ~80 patients had blood pressure drop of >20 six required iv fluids ~80 patients dropped 02sat>5% after preoxygenation Four member team Propofol literature Propofol vs Ketamine in pediatric critical care Vardi et al Critical Care Medicine 2002 Prospective randomized n=105 Propofol vs Ketamine midazolam fentanyl Propofol 2.5mg/kg vs Ketamine 2.5mg/kg/ midazolam 0.1mg/kg fentanyl 2ug/kg SIGNIFICANT DIFFERENCE ADVERSE EFFECTS REQUIRING INTERVENTION WITH PROPOFOL Propofol Safety 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? Proceed with caution Is Ketamine Safe in Head Injured Patients? MAYBE 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 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 Ketamine Head Injury 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 in cerebral perfusion pressure Decrease in cerebral blood flow velocity Decrease in EEG power Maintains cerebral autoregulation Ketamine Head Injury Ketamine effects on cerebral hemodynamics poorly understood May or may not increase regional cerebral blood flow but minimal effects on metabolism Increases neuronal activity May have a neuroprotective effect as a NMDA antagonist S+isomer may have less cerebral effects Ketamine Head Injury Maybe 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? Who Cares? Patient profile Controversies Sedation and Induction in ER Multiple medication options Significant potential adverse effects with most meds but few significant complications Literature relatively weak in design and numbers with multiple manipulations of data Significant pharmaceutical money at stake Controversies Safety is paramount*-- enhance with drug knowledge, preprocedure assessment, monitoring and discharge criteria Efficacy is important but sedation depth is poorly defined and measured Efficiency is important but cannot preclude safety and efficacy Medicolegal concerns necessitate improved documentation Ideal Drug? Controversies ??????