Charles J. Cot é, MD Professor of Anesthesiology & Pediatrics Northwestern University

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