1. Cote,C,Charles,J,Helen,W,Notterman,DA,Daniel
A.,Weinberg JA,Mc CLoskey C. Adverse sedation
events in pediatrics ;analysis of medication used for
sedation.
Pediatrics 106:…..:2000.
118 cases from the adverse drug reporting
System of the FDA,US Pharmacopeia and a results of a survey of
pediatric specialists
not harmed(+
extra Hosp stay)
death
permanent
neurol injury
2. Allocation of medication related
adverse events
drug interaction
drug overdose
premature
discharge
prescr/transcripti
on error
idadeq
understanding of
adm.medications
adm by
unsupervised
3. Relationship of interest of negative
outcome
•
•
•
•
No with general category of drug
No with route of administration
Yes with 3 or > sedation medications
12 pts suffered at home or in auto;chloral
hydrate most frequently involved
• Dental specialists overrepresented:39%!
4. Sedation and general anaesthesia in children
undergoing MRI and CT: adverse events and
outcomes.
Malvija S. et al. Br. J. Anaesth. 84:743-8, 2000
• RCT
• MRI and CT (01/ ’97-01/ ’98 from 0 to 18 yr)
• University of Michigan Health Care Systems
• Sedation (922) / GA (140)
Sedation/Age
Not Adequate sedation/ASA
6
30%
4
20%
2
10%
0%
ASA 1-2
ASA 3-4
0
Adequate
Not Adequate
Sedation
6. Sedation procedures in MRI imaging: safety,
effectiveness, and nursing effect on
examinations.
Bluemke D. et al. Radiology 216:645-52, 2000
•
•
John Hopkins Hospital, Baltimore 1991-1998
6.093 patients, 4.761 (78,1%) received conscious
sedation by the MR conscious sedation service
• Complications: 20 patients of 4.761 (0,42%), no death.
Age
range
400
300
164
N° 200
195
183
84
125
84
Dose
Indication
0-3
325
Medication
Chloral Hydrate
80-100
mg/kg
Sedativehypnotic
Sedativehypnotic
3-7
Pentobarbital
4-6 mg/kg
7-18
Diazepam
0.2 mg/kg
Antianxietysedative
>18
Alprazolam
0.5 mg/23kg
Antianxietysedative
100
0
10-20
20-30
30-40
40-50
Age
50-60
60-70
70-100
7. Sedation procedures in MRI imaging: safety, effectiveness, and nursing effect on
examinations. Bluemke D. et al. Radiology 216:645-52, 2000
2500
CH: Chloral hydrate
4,8%
D: Diazepam
2000
P: Pentobarbital
4,9%
A: Alprazolam
1500
1000
O: Other
M: Midazolam
2081
13,1%
1498
500
0
6,2%
588
D i.v.
D os
16%
497
48
CH
Failed sedation
N° pts
9,4%
P
A
49
O
Adverse Event during Conscious Sedation
N° patients
6
Agitation
5
Bronchospasm
4
Congestion and
coughing
Hypotension
3
2
Desaturation
1
Seizure
0
CH
M
P
Vomiting
• Complete MR examination: 93,5%
• Mean time to sedate patients:
• 23,6 ± 15,2 min for
specialized MR nurses
• 26,8 ± 20,1 min for general
radiology nurses (p<0.001)
8. MacIntyre PA,Sury MRI.Is propofol infusion
better than inhalational anesthesia for
paediatric MRI?
Anaesthesia 51;517,1996
43 children
6 difficult veins
3 intrascan airway manipulations
3 abandonement of technique
Haloth induction
SaO2 88-89% in 6
9 repetition of scan sequences
Induction with propofol 1-3 mg/kg
Maint:propofol 5 mg/kg/h
30 required additional boluses
of propofol 1 mg/kg;
In 5, 2-3 mg/kg
Recovery < 3 min,but in 9 >10 min
9. Vangerven M.,Van Hemelriick J,Wouters
P,Vandermeersch E,Van Aken,H.Light
anesthesia with propofol for paediatric MRI
Anaesthesia 47;706-7,1992
• 20 children,1 mo-12 years from
neuropediatrics
• Atropine syrup 0.02 mg/kg
• Propofol induct 1 + 8 mg/kg/hr
10. Vangerven M.,Van Hemelriick J,Wouters
P,Vandermeersch E,Van Aken,H.Light
anesthesia with propofol for paediatric MRI
Anaesthesia 47;706-7,1992
•
7
SaO2 99%
6
5
4
PECO2
additional boluses
mean tot prop dose
3
2
1
0
3
10
20
min
30
11. Initial experience with i.v. pentobarbital sedation for
children undergiong MRI at a tertiary care pediatric
hospital: the learning curve
Greenberg et al. Pediatr Radiol 30:689-691, 2000
•
•
•
100 children in MRI (ASA I-II); 2-15 ys with mean age of 6,8 ys
Weight from 11,4 to 70 kg with a mean of 28 kg
Max 6 mg/kg pentobarbital in 3 divided doses with total dose ≤
200 mg administrated by radiologists (PALS certificated)
100
8
80
3 > 12 y old*
60
40
92
3 > 50 kg*
(*p < 0.05)
20
0
Failed
Successful
Sedation
12. Initial experience with i.v. pentobarbital sedation for
children undergoing MRI at a tertiary care pediatric
hospital: the learning curve
Greenberg et al. Pediatr Radiol 30:689-691, 2000
Number of cases
Adverse reaction to Pentobarbital in 100 children
10
9
8
7
6
5
4
3
2
1
0
Hyperreaction
Desaturation
7
6
Cough
3
2
1
Adverse reaction
1
Prolonged
sedation
Nasal congestion
Vomiting
13. Intravenous sedation for MR Imaging of the brain and
spine in children: Pentobarbital vs Propofol
Bloomfield E.L. et al. Radiology 186:93-97, 1993
•
•
•
RCT from April 1991 to February 1992 (Cleveland Clinic Foundation)
30 pts received i.v. Pentobarbital 2,5 mg/kg (to a max of 7,5 mg/kg) by radiologists
31 pts received i.v. Propofol 1-2 mg/kg + 6-10 mg/kg/h (premed. 0.05/12 Kg
glycopyrrolate) first 10 by anesthesiologists then by radiologists (Control- A-Flow
Regulator Extension Set, Baxter)
Group
Data
Age (y) (mean/range)
Sex (M/F)
Weight (kg) (mean/range)
Original diagnoses:
• Seizures
• Neurofibromatosis I
• Developmental delay
• Cerebral palsy
• Dysmyelination syndrome
• Spinal dysraphism
• Chiari malformation
• Brain tumor
• Infarct
• Diskitis
• Headache
Propofol (n=31)
Pentobarbital (n=30)
5 / 2 – 11
15 / 16
20 / 11.5-34.0
4/2–8
18 / 12
17.9 / 9-50
10
2
3
4
0
0
2
9
0
0
1
11
4
3
2
2
2
2
1
1
1
1
14. Intravenous sedation for MR Imaging of the brain and
spine in children: Pentobarbital vs Propofol
Bloomfield E.L. et al. Radiology 186:93-97, 1993
120
p=0,05
100
80
Pulse
SpO2
MAP
RR
60
40
20
0
Mean t=0
% drop
% rise
Mean Mean
% drop % rise
Propofol
Mean t=0
% drop
% rise
Mean Mean
% drop % rise
Pentobarbital
15. Intravenous sedation for MR Imaging of the brain and
spine in children: Pentobarbital vs Propofol
Bloomfield E.L. et al. Radiology 186:93-97, 1993
50
45
Pentobarbital
Propofol
Time (min)
40
35
30
34
25
20
15
21,5
10
5
0
12,5
5
Arousal
Discharge
P=0.0005
P=0.0001
16. Anaesthesia for magnetic resonance imaging: a survey
of current practice in the UK and Ireland
McBrien M. E. et al. Anaesthesia 55:737-743, 2000
•
Postal questionnaire was sent to 120 MRI units in UK and 6 in Republic of
Ireland
100 (79%) responses:
•
– 46 units had an anaesthetic service (36 units on a regular basis, 10 on demand)
Sedation ever provided by nonanaesthetic personnel
Sedation provided by anaesthetic consultants
12
25
10
20
6
N° Units
N° Units
8
12
10
21
8
4
15
5
2
0
15
5
0
Radiologists
Paediatricians
Both
9
GAA
GPA
NAP
7
NA
GAA: General Adult Anaesthetist
GPA: General Paediatric Anaesthetist
NAP: Neuroanaesthetist with regular Paediatric practice
NA: Neuroanaesthetist with no regular paediatric practice
17. Patient demographics
Preoperative assesment
30
25
25
20
15
N° Units
N° Units
20
28
15
10
23
10
5
0
2
Only
Adults
9
Mainly
Adults
6
Only
Children
1
13
5
8
2
Mainly
Not
Children answered
0
A
B
C
D
A: Only at arrival on scan
B: On ward prior to scan
C: Seen at assesment clinic prior to scan
D: Questionnaire returned by referring clinician
•
•
•
Written consent for anaesthesia was obtained in 40 units but only 20 units had
written information about anaesthesia
44 of 46 units providing anaesthesia always had anaesthetic assistance, 2
had occasional assistance
Remote monitoring in 35 units
McBrien M. E. et al. Anaesthesia 55:737-743, 2000
18. Ventilator
Anaesthetic machine
2
2
2
15
27
A
B
C
D
A: MR-compatible anaesthetic machine inside the scanning room
B: Long breathing system tubing fed into the scanning room from a
remote anaesthetic machine
C: Non compatible gas delivery system bolted to the wall inside
D: Nothing (only sedation and never GA)
Ventilation
12
15
A
B
C
A: remote ventilator in the control room with circuit tubing fed into SR
B: Non compatible ventilator attached to the wall inside
C: Ambu bags attached to an oxygen supply if ventilator was required
• 15 units had not scavenging of gases
in the induction area
1
16
• 13 units had not scavenging of gases
in the scanning room
29
SB
IPPV
Both
• 18 units had a separate recovery room
equipped with NIBP, SpO2, ECG
McBrien M. E. et al. Anaesthesia 55:737-743, 2000
19. Adverse events and factor associated with the sedation
of children by nonanesthesiologists
Shobha Malviya et al. Anaesth Analg 85:1207-13,1997
•
•
•
•
•
•
•
•
•
•
•
University of Michigan Hospital, october 1995-1996
1.140 children
mean age (2,96±3,7)
ASA I-II 848 (81%)
ASA III-IV 199 (19%)
MRI 48%
TC 27%
Cardiac catheterization 2%
Echocardiogram 20%
Other 3%
Conscious sedation 604, deep sedation 294
21. Relationship of age to the incidence of adverse events
in sedated children. *P<0.05
100
% Children
80
All events
Respiratory events
60
*
40
20
0
ASA I-II
*
ASA III-IV
Shobha Malviya et al. Anaesth Analg 85:1207-13,1997
22. Relationship of age to the incidence of adverse events
in sedated children. *P<0.05 **P<0.0001
100
All events
Respiratory events
% Children
80
60
40
20
0
*
<1 mo
**
1-12 mo
13-24 mo
25 mo-12 yr
>12-18 yr
Shobha Malviya et al. Anaesth Analg 85:1207-13,1997
23. Summary
• Respiratory depression:
– 5,5% experienced hypoxemia, 2 became apneic and
required resuscitation.
– Several reports of mild hypoxemia and airway
obstruction requiring IOT in children who received
chloral hydrate as a sole sedative for CT scan.
– Chloral hydrate may selectively depress genioglossus
activity >>>> airway obstruction
– In this study, chloral hydrate in recommended doses
(38-83 mg/kg) as a sole drug is associated with a
significant risk of oxygen desaturation
24. Concluding
• Importance of diligent monitoring throughout the
sedation experience until the child has met discharge
criteria, regardless of the sedative administered or its
route of administration >>>> early detection and early
intervention
• Cotè reported an anecdotal incident of death from the
practice of administering chloral hydrate to an infant at
home before arrival in the hospital
• Inadequate sedation with chloral hydrate (5-15%)
resulted in either a prolonged or a failed procedure.
• A larger portion of children who had received
combinations of sedatives that included chloral hydrate
experienced inadequate sedation compared with those
who had received chloral hydrate alone.
• The individual response to chloral hydrate is varied and
unpredictable.
25. • Older children had a greater failure rate (15%)
compared with younger children (5%) for chloral
hydrate sedation.
• In older children, it may be preferable to
consider alternative sedation regimens that
combine chloral hydrate with another sedative.
• Prolonged or aborted procedures may be costly
to the institution, as well as inconvenient for the
patient, who may be required to return for a
repeated procedure with general anesthesia.
• Neonates and infants less than one year old,
and ASA III-IV all age, are at greater risk of
adverse events related to sedation.
26. Chloral hydrate toxicity
• Chloral hydrate is a reactive metabolite of
trichloroethylene, an industrial solvent. Is it
responsible for the carcinogenicity of
trichloroethylene?
• The carcinogenicity of richloroethylene is due to a
reactive intermediate epoxide metabolite.
• Trichloroethylene is carcinogenic in some laboratory
animal species but not in others.
• Multiple epidemiologic studies in humans have failed
to document an increase in cancer incidence.
27. Randomised double-blind clinical trial of intermediate
vs high-dose chloral hydrate for neuroimaging of
children
Martì-Bonmatì et al. Neuroradiology 1995;37:687-691
•
Background:
– Recommended paediatric dose is 50 mg/kg orally.
– Previous study shown a successfull of sedation in 90% of cases with
70 mg/kg orally.
– Higher doses did not seem justified (risk of prolonged sedation, rising of
adverse reaction)
– Some studies have concluded that 100 mg/kg provides effective and
safe sedation (Greenberg 1993).
28. Randomised double-blind clinical trial of intermediate
vs high-dose chloral hydrate for neuroimaging of
children
Martì-Bonmatì et al. Neuroradiology 1995;37:687-691
•
Materials and methods:
–
–
–
–
97 children undergoing MRI (Valencia University)
Mean age 38 ± 31 month
Mean weight 14,7 ± 6,4 kg
Randomized (double-blind) in two groups:
• A Group: 70 mg/kg of orally syrup 30 min before scanning
• B Group: 100 mg/kg of orally syrup 30 min before scanning
– O2 supplementation during exam
– Indications:
• Congenital craniocerebral abnormalities (33)
• Epilepsy (21)
• White matter disease (11)
• Development delay (11)
• Congenital spine disease (10)
• Cerebral-spinal tumor (11)
29. Percentage of effectiveness after the initial dose
and the total dose
Initial dose
Total dose
p < 0,05
% Successful examination
100
92
100
87
80
64
60
40
20
0
Group A
Group B
(70 mg/kg)
(100 mg/kg)
Martì-Bonmatì et al. Neuroradiology 1995;37:687-691
30. Degree of of acceptance of the two syrups
by the children
Bad
Medium
Good
Degree of acceptance %
60
Chi-squared: p < 0,05
55
50
43
40
30
28,5
28,5
30
20
15
10
0
70 mg/ml
100 mg/kg
Martì-Bonmatì et al. Neuroradiology 1995;37:687-691
31. Initial and the total dose in patients
with failed and successful axamination
Failure
Successful examination
90
p < 0,01
p < 0,05
Dose (mg/kg)
80
70
60
50
Initial dose
Total dose
Martì-Bonmatì et al. Neuroradiology 1995;37:687-691
32. Adverse reactions (21%) was similar in both groups A-B
Vomiting
Excitement
Nausea
Stomach pain
5% 5%
10%
80%
Martì-Bonmatì et al. Neuroradiology 1995;37:687-691
33. Anaesthesia with midazolam and S-(+)-ketamine in
spontaneously breathing paediatric patients during MRI
Haeseler G, et al. Paediatric Anaesthesia 2000;10:513-519
• RCT study
• Department of Anaesthesiology, Hannover Medical
School
• MRI from april 1998 to march 1999
Materials and methods:
•
Prospective study of 34 patients (8 months – 7 years) undergoing
MRI
– Randomized in two groups:
• 1st Group:
Premedication with 0,5 mg/kg of rectal midazolam
Induction with 3-5 mg/kg of methohexital, 0,5 mg/kg
atracurium
IOT and IPPV (FiO2 0,4, End tidal Isoflurane 1 ± 0,3%)
34. •2nd Group:
premedication with 0,5 mg/kg of rectal midazolam and 5 mg/kg of S-(+)ketamine
O2 supply 2-3 L/min by two nasal prongs
Continuous nasopharyngeal EtCO2 monitoring
0,05 mg/kg midazolam and 0,25 mg/kg S-(+)-ketamine until adequate
immobilization
All patients received 0,01 mg/kg atropine i.v. and 0,05% xylometazoline nasal
Standard operating room monitoring
Haeseler G, et al. Paediatric Anaesthesia 2000;10:513-519
37. S-(+)-ketamine
Clinical superiority in anaesthetic
potency compared to its optical
enantiomer R-(-)-ketamine
Superiority in recovery time
Superiority in neuroprotective effects
Shorter induction and discharge times
39. • D:Anesth outside OR Gurman
• D:bis e tci modena
• D:propofol tci e bis monitoring dentro bis monit
and consciousness
• RMN
• Propofol tci e anest reg modena;il + completo
per la metodica…………….
• Modena 12403komplet
• Macmida per le scale di sedaz