Charles J. Coté, MD
Professor of Anesthesiology & Pediatrics Northwestern University
Vice ChairmanDepartment of Pediatric Anesthesiology
Children’s Memorial HospitalChicago Illinois
Sedation Guidelines:
where have we been &
where are we headed
Sedation GoalsSedation Goals
• 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
Source of Data - Final Set
FDA 57 USP 3 Survey 27 Anonymous 8 Total 95
Quotable quotes in reports !!!!
“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 interactionPoor 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
Age Distribution
< 6 mon 9 6 mon – 6 yrs 61 > 6 yrs 25
ASA Physical Status
1 or 2 68
3 or 4 25
Unknown 2
Outcome• Death / Neurologic Injury• Prolonged hospitalization
or No Harm
60
35
CausesDrug Interaction 44 Overdose 34 I nadequate monitoring 27 I nadequate CPR 19 I nadequate work-up 18 Premature discharge 11 I nadequate Personnel 10
Drug Category
Opioid 22 Benzodiazepine 18 Barbiturate 19 Sedative 21 Chloral Hydrate 13 Ketamine 1
Number of Medications
One 47 Two 21 Three 8 Four 14 Five 1 Unknown 4
Route of Administration (Death)
I V 60
Oral 37
Rectal 9
Nasal 4
IM 31
I nhalation 13
Presenting Event (1st - 2nd - 3rd)
Event 1st 2nd 3rd
Respiratory 80 26 2
Cardiac 8 30 11
Other 7 4 2
Total 95 60 15
Outcomes by Specialty
Specialty Death/Injury Percent
Dental 29 91
Radiology 11 73
Cardiology 3 60
ER 0 0
Venue of EventHospital 41
Non-Hospital 22
Home 8
Auto 4
Unknown 20
Outcome vs Monitoring
Outcome Oximeter (N = 21)
None (N = 18)
Death/Injury 4 14*
No harm 17 4
* P < 0.001 compared with pulse oximetryPediatrics 105:805-814, 2000
Outcome vs Monitoring (Oximetry vs. Venue)
Rescue No Rescue
Hospital 15 0
Office 1 4*
* P < 0.01 Office vs. Hospital
Pediatrics 105:805-814, 2000
Demographics vs Venue
Hospital Non-Hospital P value
Age (years)
3.8 3.8 7.0 5.8 0.015
Weight (kg)
16 12 26 20 0.021
ASA status
<0.001
Pediatrics 105:805-814, 2000
First Second Third0
10
20
30
40
50
60
70
Pe
rce
nt
(N =
95
)
2.3
14
710.7
53.6
25
Hospital BasedNon-Hospital Based
Cardiac Arrest
Pediatrics 105:805-814, 2000
* P < 0.001* P < 0.001
*
*
Death/Injury0
10
20
30
40
50
60
70
80
90
100P
erc
en
t (N
= 9
5)
37.2
92.8Hospital BasedNon-Hospital Based
Pediatrics 105:805-814, 2000
Death / Injury vs. Venue*
* P < 0.001
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
Coté’s Caveats
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
“conscious sedation” is an
oxymoron
The intended sedation level is difficult to achieve
Intended Deep General Anesthesia
Moderate 32 26 0
Deep 156 136 16
General Anesthesia
103 63 39
Dial S, et al: Pediatr Emerg Care 17:414-420, 2001 – 301 sedations
Pulse oximetry is essential
First Diagnosis of Desaturation
0
10
20
30
40
50
60
Total events
OximeterAnesthesiologist
Capnograph
Coté et al: Anesthesiology 74:980-987, 1991, 1991
ASA & JCAHOPractice Guidelines for Sedation
and Analgesia by Non-Anesthesiologists 1996
Did not address deep sedation !!
ASA & JCAHO
Working together new definitions
New Sedation Terminology
• Minimal = “anxiolysis”• Moderate =
“conscious sedation” or “sedation/analgesia”
• Deep = deep sedation/analgesia
The concept of RESCUE
Minimal = Rescue from Moderate Sedation
Moderate = Rescue from Deep Sedation
Deep = Rescue from General Anesthesia
What does rescue mean?
Rescue• Airway• Airway• Airway• Airway• Airway
Rescue• Observation• Timely recognition of event• Timely diagnosis of event• Skills needed for
intervention Advanced airway skills CPR skills
Further ASA Responses 2002
Minimal SedationResponse Normal response to
verbal stimulation
Airway Unaffected
Ventilation Unaffected
CV function Unaffected
Moderate SedationResponse Purposeful response to verbal
or tactile stimulation
Airway NO intervention required
Ventilation Adequate
CV function Usually maintained
Reflex withdrawal is NOT considered purposeful
Deep SedationResponse Purposeful response
following repeated or painful stimulation
Airway Intervention may be required
Ventilation May be adequate
CV function Usually maintained
Reflex withdrawal is NOT considered purposeful
Pediatrics 110:836-838, 2002 (October issue)
The Most Recent AAP Addendum
All practitioners must use the same
monitoring guidelines
including all office based settings
(AAP)
Now ASA, AAP and JCAHO are all using the same language
and definitions
Victory?
Almost!
Sources of Controversy
American Academy of Pediatric
Dentists
Sources of Controversy
• AAPD definitions:• “conscious sedation levels 1, 2, 3”
• Use of home prescriptions• Need to join other major
medical organizations
(AAP) (ASA) (JCAHO)
There is hope
An AAP/AAPD taskforce exists
2 Revisions so far!
It will be a state to state battle to change dental
practice laws
This is what has to stop!
Controversial IssuesKetamine Full stomach? Definition?
Propofol Who should use it?Who should not use it?
Remifentanil Who should use it?Who should not use it?
Capnography When is it needed?
Recovery How long? Which drugs?
Fasting How long?Quality of evidence?
Sedation Score Consistent AAP & ASA?
Controversial IssuesKetamine No aspiration in 1000
sedations – power?
“Dissociative state”
Different from minimal, moderate, deep sedation or even general anesthesia ???
Does not depress respirations??
1-2% Apnea, laryngospasm??
Controversial IssuesPropofol Who should use it?
Who should not use it?
Guenther et al: 2003
ER: 4% jaw thrust, 1% apnea (291 sedations)
Bassett et al: 2003
ER: 5% hypoxia, 3% jaw thrust, 0.8% apnea (399 sedations)
Barbi et al: 2003
ER: 1059 sedations (483 EGD) 10 laryngospasms, 4 major desaturations
Seigler et al: 2001
ICU: 261 MRI sedations 1 unplanned intubation
Controversial Issues
Capnography When is it needed?
Yldzdas et al:2004
ER: 126 sedations MDZ/K v. propofol (52% prop = ETCO2 > 50)
Connor et al: 2003
MRI: 165 sedations pentobarbital = normal ETCO2
Coté et al: 2004
Cardiac Cath 44 sedations R2 = .8 ETCO2 v. PaCO2
Controversial IssuesRecovery How long?
Which drugs?
Coté et al 2000 CH, DPT, IM-Pentobarbatol
Malviya et al:2004
CH
Kao et al:1999 CH
Terndrup et al: 1991
DPT
Controversial Issues
Fasting How long?Quality of evidence?
Agrawal et al: 2003
ER: 905 sedations 56% inadequate fasting no aspiration events
Pena et al: 1999
ER: 1180 sedations 5 vomiting no aspirations
Kennedy et al: 1998
ER: 260 sedations no aspirations
Controversial IssuesSedation Score
Is it consistent with AAP & ASA??
1 Anxious, agitated, restless
2 Cooperative, oriented, tranquil
3 Asleep, brisk response to cheek stroke
4 Asleep, sluggish response to cheek stroke
5 No response cheek stroke, responds to painful stimuli
6 No response to painful stimuli
Top Related