Transcript Cote "Sedation Guidelines: Where have we been

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
Sedation 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
Source of Data - Final Set
FDA
USP
Survey
Anonymous
57
3
27
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 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
Age Distribution
< 6 mon
6 mon – 6 yrs
> 6 yrs
9
61
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
Causes
Drug Interaction
Overdose
Inadequate monitoring
Inadequate CPR
Inadequate work-up
Premature discharge
Inadequate Personnel
44
34
27
19
18
11
10
Drug Category
Opioid
Benzodiazepine
Barbiturate
Sedative
Chloral Hydrate
Ketamine
22
18
19
21
13
1
Number of Medications
One
Two
Three
Four
Five
Unknown
47
21
8
14
1
4
Route of Administration
(Death)
IV
60
Oral
37
Rectal
9
Nasal
4
IM
31
Inhalation
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 Event
Hospital
41
Non-Hospital
22
Home
8
Auto
4
Unknown
20
Outcome vs Monitoring
Outcome
Death/Injury
No harm
Oximeter
(N = 21)
None
(N = 18)
4
14*
17
4
* P < 0.001 compared with pulse oximetry
Pediatrics 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
Cardiac Arrest
70
Percent (N = 95)
60
Hospital Based
Non-Hospital Based
53.6 *
50
* P < 0.001
40
25 *
30
20
10.7
14
7
10
2.3
0
First
Second
Third
Pediatrics 105:805-814, 2000
Death / Injury vs. Venue
100
92.8 *
Hospital Based
Non-Hospital Based
Percent (N = 95)
90
80
70
60
50
37.2
40
30
20
10
0
* P < 0.001
Death/Injury
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
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
Moderate
General
Anesthesia
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
60
50
40
30
Total events
Oximeter
Anesthesiologist
Capnograph
20
10
0
Coté et al: Anesthesiology 74:980-987, 1991
ASA & JCAHO
Practice Guidelines for Sedation
and Analgesia by NonAnesthesiologists 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
What does rescue mean?
Minimal = Rescue from Moderate Sedation
Moderate = Rescue from Deep Sedation
Deep = Rescue from General Anesthesia
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 Sedation
Response
Normal response to
verbal stimulation
Airway
Unaffected
Ventilation
Unaffected
CV function
Unaffected
Moderate Sedation
Response
Airway
Purposeful response to verbal
or tactile stimulation 
NO intervention required
Ventilation
Adequate
CV function
Usually maintained
 Reflex withdrawal is NOT considered purposeful
Deep Sedation
Response
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
The Most Recent AAP
Addendum
Pediatrics 110:836-838, 2002 (October issue)
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 Issues
Ketamine
Full stomach? Definition?
Propofol
Who should use it?
Who should not use it?
Who should use it?
Who should not use it?
When is it needed?
How long? Which drugs?
Remifentanil
Capnography
Recovery
Fasting
How long?
Quality of evidence?
Sedation Score Consistent AAP & ASA?
Controversial Issues
Ketamine
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 Issues
Propofol
Who should use it?
Who should not use it?
Guenther et
al: 2003
Bassett et al:
2003
ER: 4% jaw thrust, 1% apnea
(291 sedations)
Barbi et al:
2003
Seigler et al:
2001
ER: 5% hypoxia, 3% jaw
thrust, 0.8% apnea (399
sedations)
ER: 1059 sedations (483 EGD)
10 laryngospasms, 4 major
desaturations
ICU: 261 MRI sedations 1
unplanned intubation
Controversial Issues
Capnography When is it needed?
Yldzdas et al: ER: 126 sedations MDZ/K
v. propofol (52% prop =
2004
ETCO2 > 50)
Connor et al: MRI: 165 sedations
2003
pentobarbital = normal
ETCO2
Coté et al:
Cardiac Cath 44 sedations
2004
R2 = .8 ETCO2 v. PaCO2
Controversial Issues
Recovery
How long?
Which drugs?
Coté et al 2000
CH, DPT, IMPentobarbatol
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
Pena et al:
1999
ER: 905 sedations 56%
inadequate fasting no
aspiration events
ER: 1180 sedations  5
vomiting no aspirations
Kennedy et
al: 1998
ER: 260 sedations  no
aspirations
Controversial Issues
Sedation Is it consistent with AAP &
Score
ASA??
1
Anxious, agitated, restless
2
Cooperative, oriented, tranquil
3
Asleep, brisk response to cheek
stroke
Asleep, sluggish response to
cheek stroke
No response cheek stroke,
responds to painful stimuli
4
5
6
No response to painful stimuli