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Charles J. Cot é, MD Professor of Anesthesiology & Pediatrics Northwestern University Vice Chairman Department of Pediatric Anesthesiology Children’s Memorial Hospital Chicago Illinois. Sedation Guidelines: where have we been & where are we headed. Sedation Goals. Anxiolysis
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Charles J. Coté, MD Professor of Anesthesiology & Pediatrics Northwestern University Vice Chairman Department of Pediatric Anesthesiology Children’s Memorial Hospital Chicago Illinois
Sedation Guidelines: where have we been & where are we headed
SedationGoals • Anxiolysis • Analgesia • Amnesia • Safety • Control behavior • Return to baseline
American Academy of Pediatrics Guidelines Response to Dental Accidents
Guidelines for the Elective use of: • Conscious sedation • Deep sedation • General anesthesia Pediatrics 76:317-321, 1985
Conscious Sedation Medically controlled state of depressed consciousness • protective reflexes maintained • maintain airway independently • appropriate response to verbal command or physical stimulation (NOT REFLEX WITHDRAWAL)
Deep Sedation Medically controlled state of depressed consciousness: • not easily aroused • may not maintain airway • may not respond to verbal command • may not respond to physical stimulation (EASILY MOVES TO GENERAL ANESTHESIA)
Guidelines for Monitoring and Management of Pediatric Patients during and after Sedation for Diagnostic and Therapeutic Procedures Pediatrics 99:1110-1115, 1992
Guideline Emphasis • Pre-sedation evaluation • Appropriate fasting • Informed consent • Monitoring • Time-based record • Recovery facility • Discharge criteria • No out of facility prescriptions
Source of data: • FDA adverse drug reports (629) • USP • Survey Pediatric • Anesthesiologists (310) • Intensivists (470) • Emergency Medicine (575) • Anonymous
Outcome Measures: • Death • Neurologic Injury • Prolonged Hospitalization • No Harm Pediatrics 105:805-814, 2000
Critical Incident Analysis What went wrong? Why? How can we prevent it from happening again?
Methodology: • Each case reviewed independently • Daniel Notterman MD • Helen Karl MD • Joseph Weinberg MD • Charles Coté MD • All cases debated • Only cases accepted = total agreement Supported by Roche Pharmaceuticals
“The patient was not on any monitors” Self evident death
“The patient received tablespoons instead of teaspoons” Dispensing error death
“If they made nurses stay after 5 PM they would all quit” Inadequate recovery procedures rescued by a friend!
“Physician administered medication and left facility leaving the patient with a technician” Inadequate personnel death
“patient given 175 µg fentanyl IV chest wall rigidity” They did not understand pharmacodynamics neurologic injury
“6-wk old infant received Demerol Phenergan and Thorazine for a circumcision found dead in bed” Drug-drug interaction Poor drug selection
“Drug given at home by a parent” Lack of medical supervision death
“Anesthesia given by a gynecologist” You can’t do two things at the same time death
“The child received 6,000 mg of chloral hydrate” Drug overdose death
“Child became stridorous and cyanotic on the way home” Premature discharge rescued
“An oxygen outlet available but no flow meter…no oxygen for 10 minutes” Inadequate equipment Neurologic injury
Death / Neurologic Injury Prolonged hospitalization or No Harm 60 35 Outcome
Outcome vs Monitoring * P < 0.001 compared with pulse oximetry Pediatrics 105:805-814, 2000
Outcome vs Monitoring (Oximetry vs. Venue) * P < 0.01 Office vs. Hospital Pediatrics 105:805-814, 2000
Demographics vs Venue Pediatrics 105:805-814, 2000
Cardiac Arrest * * P < 0.001 * Pediatrics 105:805-814, 2000
Death / Injury vs. Venue * * P < 0.001 Pediatrics 105:805-814, 2000
Non-hospital Patients • Older • Heavier • Healthier (lower ASA status) • Deader !!!!!!!!!!!!!
Non-Hospital vs. Hospital • FAILURE TO RESCUE • INADEQUATE CPR SKILLS
CONCLUSIONS • Not the drugs, route of administration, or the patient population • Monitoring makes a difference • Need Systems approach • Need CPR skills to rescue patients
Infants and children require pharmacologic coma to remain still for a procedure
Drug effects are the same regardless of: • Route of administration • Who gives them • Where they are given
The intended sedation level is difficult to achieve Dial S, et al: Pediatr Emerg Care 17:414-420, 2001 – 301 sedations