Transcript Slide 1

Pediatric Procedural
Sedation in the Emergency
Department
15 years later...... Are we there yet?
Bo Kennedy, MD
Pediatric Emergency Medicine
Urgent Painful Procedures in ED
•
•
•
•
•
Fracture reduction
Burn debriedment
Abscess drainage
Laceration repair
I.V. placement,
venipuncture
• Lumbar puncture
• NG tube placement
15 years ago....
Kids were half as likely as adults
to receive pain medications in the
ED for painful conditions....
(fractures, burns, SS pain crises)
– 30% kids vs 60% adults got pain meds
» Steve Selbst, Ann Emerg Med, 1990
15 years ago.... Undertreatment
Why?
1.
2.
3.
4.
5.
Kids thought not to feel or remember pain
Kids expected to cry
Fear of adverse effects of opioids
Lack of training
Lack of consensus on meds, monitoring
» Selbst, Drug Safety, 1992
» Schechter, Berde, Yaster, 1993
What we now know:
1. Kids thought not to feel pain
Infants have less maturation of their
descending inhibitory pain pathways
therefore they may actually experience
pain more intensely compared to older
children when exposed to the same
stimulus.
What we now know:
1. Infants’ Memory for Procedural Pain
seconds
• Distress in 87 infants during vaccination 4 to 6 months
after circumcision vs. no circumcision
80
70
60
50
40
30
20
10
0
Cry Duration
Baseline
200
180
160
140
120
Circumcised 100
80
Uncircumcised 60
40
20
0
Vaccination
Facial Action Score
Baseline
Tadio, Lancet, 1997
Vaccination
What we now know:
1. Kids’ Memory for Procedural Pain
Original study
• Children < 8 yrs
with cancer
• L.P., bone
marrow asp.
• self-report pain
Placebo
5
4.5
4
3.5
3
2.5
2
1.5
1
0.5
0
Oral Fentanyl
Original
study
For ensuing
procedures,
all received
oral fentanyl
1
2
3
Ensuing LPs and BMAs
Weisman, Arch Pediatr Adolesc Med, 1998
4
1. Next steps....Impact of Memory?
Evaluation of Long term effects
• Post Traumatic Stress Disorder
• Conscious vs subconscious memory
What we now know:
2. Kids Are Expected to Cry
Difficulty in distinguishing pain from anxiety

No objective measures of pain

Parents and Healthcare Providers tend to
underestimate children’s procedure related pain.


Schneider, CHC, 1992
“It hurts if I say it hurts!”
 David
Kennedy, 5 yr old, while backpacking
2. Measures of Pain and Anxiety
Validated Measures of Pain / Anxiety used for ED studies

When the patient is able to verbalize (self-report)
Visual Analog Scales for Pain or Anxiety (5+ yrs of age)
 Oucher Score (Beyer, 3+ yrs)
 FACES scales (Bieri, 5+ years of age)


When the patient is too young or sedated to verbalize
 Measures of distress
OSBD-r
information seeking verbal pain
(Jay, 1983)
emotional support
restraint
verbal resistance
cry
flail
scream
PBCL
(LeBaron, 1984)
muscle tension
restraint used
verbal stalling
CHEOPS
(McGrath, 1985)
Facial expression Torso position
Verbal expression Leg position
pain verbalized
cry
anxiety verbalized scream
physical resistance
Cry
Touching
wound
2. Measures of Pain and Anxiety
Needed
Practical measures developed and
validated in ED for bedside assessment of
pain or distress in verbal, pre-verbal, and
sedated children.
3. Fear of Adverse Effects
Sedation Related Disasters Related to:

Sedations in non-hospital settings, w/o
resuscitation equipment or trained personnel

Lack of use of pulse oximetry

Use of 3 or more sedating medications

Home administration of sedation meds or
discharge before sufficient recovery
» Cote, Pediatrics, 2000
3. Frequency of Adverse Effects
Review of 1,022 ED procedural sedations with ketamine
• No clinical evidence of pulmonary aspiration
Green, Ann Emerg Med, 1998
Review of 1,180 procedural sedations in pediatric ED
• 2.3% experienced adverse events
O2 sats < 90% requiring intervention
Paradoxical reactions
Laryngospasm
Emesis
Apnea
Bradycardia
Pena, Ann Emerg Med, 1999
3. Frequency of Adverse Effects
• 260 children
30
• ASA-PS I, II
• Displaced
fractures
25
• Randomized
to F/M or K/M
F/M
K/M
20
% 15
10
5
0
Hypoxia
Airway Breathing
Maneuver Cues
Oxygen
Vomiting Dysphoria
Kennedy, Ped, 1998
3. Adverse Event Timing
1,367 procedural sedations
70
Adverse Event: (% total)
60
50
Number
Potential life-threats:
hypoxia (84%)
stridor (2%)
hypotension (1%)
Other:
Emesis (6%)
Agitation (3%)
Rash (3%)
40
30
F/M
K/M
20
10
Regimens
F/M: 108 / 660 (16%)
K/M: 31 / 326 (10%)
0
-120-110-100-90 -80 -70 -60 -50 -40 -30 -20 -10 0 10 20 30 40 50 60 70 80 90 100 110 120
Minutes from final PSA medications
Newman, Ann Emerg Med, 2003
3. Adverse Effects / Events…Next?
Needed
 Uniform definitions, e.g.,
–
–
–
–
–

Hypoxia (< __% O2 sat. on Rm Air x __ seconds)
Hypercarbia (> __ rise in mm CO2 x __ seconds)
Bradycardia
Hypotension
Airway maneuvers
Frequency/Type for specific clinical scenarios
– Procedure type
– Patient type
4. Lack of Training

Development of Pediatric Emergency
Medicine

Incorporation of sedation training in EM
programs

Training guided by Procedural
Sedation/Analgesia research

Next.....Uniform training standards?
4. Effect of Training
Survey: Would you sedate for reduction of a 40
angulated radius fracture in a 3 or 8 year old?
Yes
57% general EDs
100% children’s hospital EDs
Krauss, Ped Emerg Care, 1998
5. Lack of Consensus ...monitoring
Monitoring Guidelines
 AAP,
1989, 1992, 2002
 ASA, 1996, 2002
 ACEP, 1998
 JCAHO, 2002
5. Consensus:
Goals of Sedation
• Patient safety and welfare
• Minimize pain
• Minimize negative psychological response
• Maximize amnesia
• Behavior control
AAP Committee on Drugs, 1992
5. Consensus Guidelines
Definitions
1.
2.
3.
4.
Minimal
Conscious sedation
Moderate
Deep
General Anesthesia
 AAP, ASA, JCAHO, 2002
– Dissociative sedation ? (Ketamine)
5. Consensus Guidelines
Monitoring (Deep Sedation)
Dedicated observer of pt’s
cardiopulmonary function
2. Pulse oximetry
3. HR, ECG
1.
 AAP, ASA, JCAHO, 2002
Next ?
– End-tidal CO2
5. Consensus Guidelines
Needed
Standardization of stimulus or means to objectively
determine depth of sedation, including when patient
stimulation is undesirable, e.g., MRI scan.
• BIS ?
• Standardized stimulus, command ?
Development of means to assess reactivity of
protective airway reflexes
• different agents
• different depths of sedation
5. Consensus Guidelines....NPO?

Currently recommended fasting periods for
elective sedations are based more upon longstanding practice than careful study.

ASA Taskforce, Pre-op Fasting, Anesthesiology 1999
ASA/AAP NPO Guidelines for Elective Sedation
Age
Time
Clear Liquids
All Ages
2 hours
Breast milk
Newborn - 6 months
4 hours
Infant formula
All Ages
6 hours
Solids (light meal)
> 6 Months
6 hours
5. Consensus Guidelines....NPO?

Many sedations performed in the ED do not
meet elective NPO recommendations,
especially for solids.
– e.g., 56% of 905 sedated children in Boston
Children’s ED did not meet fasting guidelines for
elective sedations.
» Agrawal, Ann Emerg Med, 2003
5. NPO......... Does it matter?

Painful injuries and narcotic pain medications may
delay gastric emptying.

Correlation of fasting time with emesis is unclear
in children sedated for urgent procedures.
(905 patients)
No emesis
Emesis
Fasting time (hours)
Solids
Clear Liquids
6.8
6.0
6.8
5.8
Agrawal, Ann Emerg Med, 2003
Pulmonary Aspiration in Children with
General Anesthesia
63,180 cases - 24 with aspiration (Mayo Clinic)
1 / 373
in emergency cases
• 1 / 4,544
in elective cases
• 9 / 24 who aspirated developed respiratory symptoms
Warner, Anesth, 1999

50,880 cases – 52 with aspiration (CHIP)
• 21 / 52 active vomiting during induction
• 15 / 52 required intervention
 Risk doubled if emergency case
Borland, J Clin Anesth, 1998
3&5. Risk of Pulmonary Aspiration and
other Adverse Events?
Needed
Large collaborative data bases (50-100,000+
cases) in which adverse events can be tracked
to help elucidate the overall risks of adverse
sedation event.
5. Lack of Consensus ...
Medications
5. 15 years later.... D.P.T.
Prospective study of 63 children
• mean age 3.6 years
• 29% were only mildly sedated
• Mean times to:
–
–
–
–
deepest sedation
discharge
eating/drinking
“ normal ”
45
minutes
4.7
hours
11 + 8 hours
19 + 15 hours
Terndrup, Ann Emerg Med, 1991
5.
•
•
•
•
•
•
•
D.P.T.
Not easily titrated
Delayed onset of action
Protracted sedation
No anxiolysis or amnesia
High rate of therapeutic failure
High rate of serious adverse effects
Alternative sedatives/analgesics should be
considered
AAP Committee on Drugs, 1995
5. 15 years later....Consensus...meds
Medication Regimens
Opioids
Ketamine
Fentanyl / Midazolam
vs. Ketamine / Midazolam
260
children, 5-15 years of age, ASA-PS I or II
Displaced fracture
Randomized
Midazolam
(0.11-0.15 mg/kg)*
Glycopyrollate
Fentanyl
(1.6 ± .66 mcg)*
Ketamine
(1.1 ±.52 mg/kg)*
* Mean 1st reduction dose, titrated to effect
Kennedy, Peds, 1998
5. F/M vs K/M: Results
100
F/M
80
K/M
60
%
40
20
0
Deep Sedation
Complete
Amnesia
Successful
First Attempt
Kennedy, Peds,. 1998
5. F/M vs K/M: Effectiveness
3
F/M
2.5
K/M
2
OSBD-R
(distress)
1.5
1
0.5
0
Pre-sedation
Procedure
Discharge
Kennedy, Peds,. 1998
F/M vs K/M : Adverse Events
F/M
30
25
P= .001
K/M
P= .001
20
%
15
P= .04
10
5
0
Hypoxia
Airway Breathing
Maneuver
Cues
Oxygen
Vomiting
Dysphoria
Kennedy, Peds,. 1998
Ketamine and Midazolam

266 children undergoing PSA in ED
Randomized
in single syringe
Ketamine (1 mg/kg) +
Ketamine (1 mg/kg) +
Midazolam (0.1 mg/kg)
Placebo
Distress
(OSBD-r)
O2 sat <90
(%)
Vomiting
(%)
Sedation
Time* (min)
Significant
Emergence (%)
Ketamine
<1
1.6
19
78
7
Ket / Midaz
<1
7.3
10
75
6
 Agitation in > 10 yr olds: 36% w/ Midazolam vs. 6% w/ Placebo
Wathen, Ann Emerg Med, 2000
Next...Ketamine & Schizophrenia?
NMDA-glutamate receptor hypofunction model of schizophrenia
Olney, J, Science, 1991
Newcomer JW, Neuropsychopharmacology. 1999
Next...Ketamine & Schizophrenia?
Newcomer JW, Neuropsychopharmacology. 1999
Next...Ketamine & Schizophrenia?
Newcomer JW, Neuropsychopharmacology. 1999
Next...Ketamine & Schizophrenia?
Newcomer JW, Neuropsychopharmacology. 1999
5. Next...Ketamine & 2- Adrenergic
Agonists?
40
young adults undergoing elective superficial surgery
Midazolam
Dexmedetomidine
(0.07 mg/kg IM)
(2.5 mcg/kg IM)
Ketamine
anesthesia
Recovery: Hallucinations, Confusion
Unrealistic Dreams, Nightmares
Midazolam
55 %
Dexmedetomidine
5%
Levanen, J, Anesthesiology, 1995
5. Next steps......Ketamine
Needed
– Use of validated measures of psychotomimetic
effects
– Further evaluation of modulation of dysphoria by
adjunctive GABA, alpha adrenergic agents
(midazolam, dexmedetomidine, barbiturates)
– Avoidance of use in patients of families with
history of psychosis?
– Variance across puberty?
15 years later....
Medication Regimens
N2O
N20 vs Midazolam: Suturing
204
children, 2-6 yrs old with facial lacerations
Standard Care (L.E.T. + comforting)
50% N2O
Oral
Midazolam
N2O +
Midazolam
Luhmann, Ann Emerg Med, Jan 2001
N2O SELF-ADMINISTRATION
by a 3 yr old
N20 vs Midazolam: Suturing
6
5
% Adverse Effects
OSBD-R
(distress)
4
3
p=.0002
p=.003
2
1
0
SC M N MN
SC M N MN
SC M N MN
Injection
Cleaning
Suturing
Ataxia
Vomiting
Std. Care
0
0
Midazolam
24
0
N2O
2
10
Midazolam
+ N2O
28
2
Luhmann, Ann Emerg Med, 2001
K/M vs N2O/HB
102
children, 5-15 yrs, mid to distal forearm fractures
Oxycodone (0.2mg/kg)
Radiographs
Enrollment
Midazolam (2mg)
and
Ketamine (1 mg/kg)
Nitrous Oxide (50%)
& Hematoma Block
(2.5 mg/kg 1% lidocaine)
Luhmann, APA, SAEM 2004
K/M vs N2O/HB
Efficacy: PBCL Scores
Ketamine
Nitrous Oxide
15
14
PBCL 13
Score
p = 0.3
( mean) 12
Recovery time:
/ M = 83  32 min
N2O/HB = 16  10 min
K
p = 0.2
p = 0.4
(p< 0.0001)
11
10
Baseline
PBCL muscle tension
restraint used
verbal stalling
Fracture
Reduction
Recovery
pain verbalized
cry
anxiety verbalized scream
physical resistance
Luhmann, APA, SAEM 2004
15 years later....
Medication Regimens:
Pentobarbital
• Long track record of safety and efficacy
• However, prolonged recovery and dysphoria
• New ultra-fast CT scans dramatically reduce
need for sedation
15 years later....
Medication Regimens:
Propofol
Propofol

Sedative anesthetic with no analgesic but some
anti-emetic and amnestic effects.
– Used for painless diagnostic procedures,
e.g., MRI or CT scans.
– For painful procedures, frequently combined with
an opioid, e.g., fentanyl, morphine
– Rapid and gentle recovery makes it an attractive
agent for brief procedures.
Propofol

For I.V. induction of general anesthesia:
1-3 mg/kg then continuous infusion
of 75-300 mcg/kg/min.

For I.V. induction of deep sedation:
1-2 mg/kg, repeated prn and/or continuous
infusion of 60-100 mcg/kg/min.
• Rapid onset: 0.5-1 minute,
• Short duration of sedation: 5-10 minutes
• Elimination half-life: 6-7 hours
Propofol

89 ASA I and II fasted children 2-18 years old
Undergoing fracture reduction
Morphine (0.24 mg/kg)
Propofol
Midazolam
(1 mg/kg/2 min) +
67-100 mcg/kg/min*
(0.16 mg/kg)
* Additional 1 mg/kg bolus in 81%
Ramsey
(mean)
Amnesia
(%)
Recovery
(min)
Hypoxemia (%)
Midazolam
4/6
91
76
11.6
Propofol
5/6
80
15
10.9
Results
(< 93% on RA)
Havel, Acad Emerg Med, 1999
Propofol

113 children ASA-PS Class I or II, 3-18 years
old, undergoing fracture reduction
Propofol
Ketamine
0.5-1 mg/kg
(mean 4.6 mg/kg)
+
1-2 mg/kg
(mean 2 mg/kg)
+
Fentanyl
Midazolam
1-2 mcg/kg
(mean 1.2 mcg/kg)
(0.05 mg/kg, max 2 mg)
Results
OSBD-r Recovery time Hypoxia
(mean) (mean) (min) (%<90%)
Emesis
Propofol / Fentanyl
0.278
21
31
0
Midazolam / Ketamine
0.084
54
7
2
Godambe, Peds, 2003
Propofol

393 sedations in children, ASA-PS I/II,
94% with fractures
• Fasted minimum of 3 hrs
• Pre-emptive oxygenation
• 3-member sedation team, in addition to
procedure team:
1. Emergency physician
2. RN documenter
3. ED technician to assist with airway mgt
Bassett, Ann Emerg Med, 2003
Propofol
Medication protocol
• Morphine 0.1mg/kg if initially in pain,
 11% of pts, mean dose 0.08
• Fentanyl 1-2 mcg/kg prior to procedure
 72% of pts, mean dose 1.2 mcg/kg
• Propofol 1 mg/kg+ 0.5 mg/kg prn
mean dose 2.7 mg/kg


92% with hypotension, usually transient
5% with hypoxia (< 90% sat), despite supplemental O2
–


Duration 1-3 minutes
Capnography not measured
No measure of procedure-related distress
Bassett, Ann Emerg Med, 2003
Propofol for ED PSA
Concerns
• Difficult to titrate to desired sedation endpoints
without overshooting to apnea and hypotension.
• Loss of protective airway reflexes during apneic
periods likely places patients at increased risk of
pulmonary aspiration, especially if positive pressure
ventilation administered. Gastric insufflation likely
induces passive regurgitation.
Propofol for ED PSA
Concerns (cont.)
• Patients must be carefully screened for “full
stomachs” and difficult airways.
• Propofol should only be used by providers with indepth knowledge of its adverse effects and skilled in
airway assessments and positive pressure ventilation.
• When propofol is administered, an experienced
provider must be dedicated to administering the
sedation and managing the airway and
cardiorespiratory status of the patient and not
involved with the procedure being performed.
Propofol for ED PSA
Needed
Large, thorough studies of patients
undergoing procedural sedation with
propofol in the ED to better clarify:
1. Risks of adverse events,
1. Effectiveness of distress reduction,
amnesia, and
1. Recovery and post-recovery experiences.
15 years later....
Medication Regimens:
Etomidate
Etomidate
• Hypnotic anesthetic- no analgesia
• Little hemodynamic effect
• Frequently used in the emergency setting to induce
unconsciousness during endotracheal intubation (RSI)
When using a dose of 0.2-0.3 mg/kg
• Onset of sedation:
15-45 seconds
• Duration of sedation: 3-12 minutes
• Rapid recovery of consciousness due to redistribution
• Clearance half-life of 1-3 hours
 Rapid administration may result in transient apnea.
Etomidate

[3 reports on non-RSI ED use]
53 children (mean age 9.7 years, range 2-17 years)
retrospective series, fracture reduction
– Mean initial dose 0.2 mg/kg (range 0.1-0.4 mg/kg)
• 17% required second dose
– Morphine (mean 0.21 mg/kg) as adjunct
– 83% procedural success rate

Adverse Effects / Events
– No desaturation below 94% on supplemental O2
(End-tidal CO2 not measured)
– No apnea, or positive pressure ventilation
– No vomiting
– Transient hypotension in 1 pt
Dickinson: Acad Emerg Med,2001
Etomidate

51 sedations in 48 patients - 18 were 1-25 years old
(most children underwent fracture reduction)
–
–
–
–

• prospective feasibility study of adverse events
Dose 0.1 mg/kg, repeated in 60%
Morphine or Fentanyl as adjuncts
“Adequate” sedation in 98%, Procedural success in 94%
Amnesia in 69%
Adverse Effects / Events
– Face mask O2 needed in 10% (max desaturation 31%)
– Bradycardia for < 30 seconds in 1 pt
– Mean drop in B.P. 12 mm (max. 48 mm in 6 yr old)
– Myoclonus in 8%
– vomiting in 2%
Ruth: Acad Emerg Med, 2001
Etomidate

150 procedures, 15 in patients 6 to 17 years of age
• retrospective, observational
– Mean initial dose 0.2 mg/kg, 2nd dose in 9%
– Adjunctive meds (opiates, benzodiazepines) in 23%
– Sedation (Aldrete Recovery Score)
• Moderate 32%,
• Deep 68%

Adverse Effects / Events
– O2 desaturation in 5 adults-- 4 received BVM (3%)
– Emesis in 2 (1.3%)
Vinson, Ann Emerg Med. 2002
Etomidate

101 patients < 19 yrs old, undergoing oncological
procedures
• Retrospective chart review
– Etomidate 0.3 mg/kg
– Fentanyl 1 mcg/kg as adjunct

Adverse events/effects
– Myoclonus in 18%
– Vomiting in 10%,
– Agitation in 4%
– Hypoxemia in 2%.
McDowell: J Clin Anesth. 1995
Etomidate
Needed
Prospective study of use in ED in Children
• Standardized protocol
– Dose (titrated to effect?)
– Analgesic adjunct
– Procedure specific
– Impact of myoclonus on CT scans, suturing?
Elucidation of risk of apnea, aspiration
Next steps......
• Comparative trials to determine safety and
efficacy of procedure specific sedation
techniques
• Use of regional anesthesia
– Fracture HB blocks
• Forearm, Ankle
– Regional Blocks
• FNB
• Personalization of sedation techniques
– Preferences: some don’t want to be ‘put to sleep’
Non-pharmacological strategies:
Positions of Comfort
SAFETY
Next steps
Building Bridges
Collaborative multidisciplinary studies
– EM Physicians and Nurses
– Anesthesiologists
– Psychologists / Psychiatrists
– Pharmacists
– Child Life Specialists