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Intranasal Midazolam
1.
2. THE MINIMUM DOSAGE & TIME
REQUIRED FOR SMOOTH
SEPARATION FROM PARENTS
PRE-OPERATIVELY
THE TITLE
INTRANASAL
MIDAZOLAM
PREMEDICATION IN
CHILDREN
3. Worker group
Guide: Professor Dr. Kazi M. Iqbal
MBBS, DA(London), FFARCS(I), FRCA(E), FCPS;
BSMMU, Dhaka.
Co-guide: Dr. Moinul Hossain
MBBS, FCPS; Assistant Professor, BSMMU, Dhaka.
Principal Investigator: Dr. (Maj) Md Rabiul Alam
MBBS, MCPS, FCPS; AFMC, Dhaka
Cantonment, Dhaka.
4. Introduction
• The anaesthesiologists face
the excited child as one of
the most common problems
in everyday experience
• This problem can be
handled with least success.
Ref: Smith RM. Anaesthesia for infants and children.
3rd Ed.: The CV Mosby Company, 1968: 5–31.
5. Introduction (Continued)
• Children admitted to hospital face a
new environment & separation from
their parents before induction further
upset them.
• Separation is an important cause of
neurotic anxiety.
• Separation anxiety is experienced
most intensely around the age of 4 yrs.
• Also cause often a noisy & unpleasant
situation in the OT.
Ref: Levy D. Psychic trauma of operations in children.
Am J Disabled Child 1945; 69: 7.
6. Introduction (Continued)
• Parental presence may not
always be beneficial.
• The unmotivated mothers may
further deteriorate the situation
Ref: Bevan JC, Johnston C, and Haig HJ: Pre-operative
parental anxiety predicts behavioural and emotional
responses to Induction of Anaesthesia in Children. Can J
Anaesth 37: 177–82.
7. Introduction (Continued)
• Anxiolysis & sedation by premedication is still
a common practice in paediatric anaesthesia.
• Key features of good premedication are:
• easy application
• rapid onset
• short duration
• lack of significant side effects
Ref: Meursing AEE. Psycological efffects of anaesthesia in
children. Curr Opin Anesthesiol 1989; 2: 335-8
8. Introduction (Continued)
• Midazolam meets these criteria with its :
• Multiple routes of administration (oral, nasal,
rectal)
• An onset time: 10-20 min
• Duration of action: approximately 30 min
• No interference with vital signs at doses < 0.5
mg.kg–1.
• Most widely used paediatric premedication in
Europe & the USA.
MIDAZOLAM
Ref: McMillan et al. Premedication of children with oral midazolam. Can J
Anaesth 1992; 39: 545-50.
9. Introduction (Continued)
• Advantages of intra-nasal route:
• Bypasses the first-pass effect
• Quick achievement of desired
serum level (even just slower
than the i. v. route)
• Good patients’ compliance (no
prick, no needle, nothing to
swallow, – specially in case of
children).
Ref: Henderson JM. Pre-induction of Anaesthesia in Paediatric patients
with nasally administered sufentanil. Anesthesiology, 1988. 68: 671-675.
10. Introduction (Continued)
• The therapeutic plasma concentration for
‘sedation’ with midazolam is 40 ng.ml–1.
• A mean peak of 72.2 ng.ml–1 can be achieved
within 10 minutes of intra-nasal midazolam at a
dose of 0.1 mg.kg–1.
• Parenteral formulation (15 mg in 3 ml) containing
0.33 mg/drop has been used for intra-nasal
administration.
Ref: Louon A, Reddy VG. Nasal midazolam and ketamine for paediatric
sedation during computerized tomography. Acta Anaesthesiol Scand
1994; 38(3): 259–61.
11. Objectives
To determine the minimum dosage &
time interval required for smooth
separation of children from their
parents at a plane of ‘conscious
sedation’ by intra-nasal instillation of
midazolam pre-operatively.
12. Methods
Forty children were assigned
randomly to one of two groups of
twenties in BSMMU, Dhaka during
the tenure of Sep ’02 - Feb ’03.
ASA- I & II
Age: 1- 6 years
13. STUDY SUB-GROUPS
10 minutes
(Random)
Sub-group: Ia
20 minutes
(Random)
Sub-group: Ib
Random 20s
0.025 mg/kg
Group: I
10 minutes
(Random)
Sub-group: IIa
20 minutes
(Random)
Sub-group: IIb
Random 20s
0.05 mg/kg
Group: II
TOTAL: 40 CHILDREN
14. Methods(continued)
HR, SBP, sedation & anxiolysis scores
were assessed:
before premedication (baseline)
at separation from parents
at application of a facemask for
induction.
Parental comments were also assessed
at the time of separation.
16. Anxiolysis levels Score
Tearful / combative 1
Anxious, but can be easily reassured 2
Calm 3
Asleep 4
Anxiolysis score levels
Score 2 & 3 were considered as ‘conscious sedation’Scores 2 & 3 were considered as ‘conscious sedation’
17. 1. Did you feel that your child was
adequately relaxed while waiting for
surgery?
2. Did you feel that your child was
adequately relaxed at the time
of separation from you to enter the
operation theatre?
PARENTAL
QUESTIONNAIRE
18. RESULTS
HR & SBP were slightly increased during
application of facemask in all four sub-
groups.
Sedation & Anxiolysis scores at separation &
induction were significantly higher in the
particular dosage-group of 0.05 mg.kg–1.
No significant differences between the interval-
subgroups of 10 & 20 minutes of the 0.05
mg.kg–1 dosage group.
Parental comments of those sub-groups were
satisfactory.
19. Report
4.000 14.100 1.30
10 10 10
1.700 4.280 .48
3.950 16.500 1.40
10 10 10
1.301 3.923 .52
4.400 14.500 1.10
10 10 10
1.468 4.410 .32
3.700 15.150 1.60
10 10 10
1.183 4.177 .52
4.012 15.063 1.35
40 40 40
1.394 4.140 .48
Mean
N
Std. Deviation
Mean
N
Std. Deviation
Mean
N
Std. Deviation
Mean
N
Std. Deviation
Mean
N
Std. Deviation
Sub-group
Ia
Ib
IIa
IIb
Total
Age (years)
Body
weight (kg) Sex
DEMOGRAPHIC DATA
Mean Age:
4.012 years
Mean Body
weight:
15.062 kg
Required mean
dose:
3 drops /case
42. CONCLUSION
So, we conclude that:
Children may be separated from their
parents smoothly & safely without exactly
inducing them asleep rather keeping them
at a plane of ‘conscious sedation’
within 10 minutes after administering
intra-nasal midazolam at a dose of
0.05 mg.kg–1.