Table 3Oral midazolam vs. placebo; Fatovich 199563, Luhman 2001152

Question: Should oral midazolam vs. placebo (with local anaesthesia in both groups) be used in children and young people under 19 years of age undergoing diagnostic and therapeutic procedures?

Settings: A & E

Bibliography: Luhman 2001152 (suturing for laceration repair) Fatovich 199563 a) (suturing for laceration repair) Fatovich 199563 b) (suturing for laceration repair)

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsoral midazolamplaceboRelative (95% CI)Absolute
Completion of procedure (Luhman 2001152)
1randomised trialserious6no serious inconsistencyno serious indirectnessno serious imprecisionnone51/52 (98.1%)50/50 (100%)1RR 0.98 (0.93 to 1.04)20 fewer per 1000 (from 70 fewer to 40 more)MODERATE
Anxiety – child assessed by observers using a validated scale (Herbertt-Michaelinees-Venham scale) (Fatovich 199563)
1randomised trialno serious limitations2no serious inconsistencyno serious indirectnessserious3none33/57 (57.9%)32/50 (64%)4RR 0.89 (0.66 to 1.21)70 fewer per 1000 (from 218 fewer to 134 more)MODERATE
Distress – child assessed by parents using a validated scale (measured with: Visual Analogue Scale (VAS); Better indicated by less) (Fatovich 199563)
1randomised trialno serious limitations2no serious inconsistencyno serious indirectnessserious3none5750-MD -1.6 (-2.81 to -0.39)5MODERATE
Adverse events: Aspiration (Luhman 2001152)
1randomised trialserious6no serious inconsistencyno serious indirectnessno serious imprecision7none0/51 (0%)70/50 (0%)not pooled-MODERATE
Adverse events: Respiratory intervention (Luhman 2001152)
1randomised trialserious6no serious inconsistencyno serious indirectnessno serious imprecision8none0/51 (0%)80/50 (0%)not pooled-MODERATE
Adverse events: Vomiting (Luhman 2001152)
1randomised trialserious6no serious inconsistencyno serious indirectnessno serious imprecision9none0/51 (0%)90/52 (0%)not pooled-MODERATE
1

Luhman 2001152: p=0.49

2

Fatovich 199563: unclear ITT and unclear drop out rate; otherwise adequate allocation concealment and double blind

3

wide confidence intervals

4

Fatovich 199563: p=0.47

5

Fatovich 199563: p=0.009

6

Luhman 2001152: adequate concealment and low loss of follow up (1 patient in the midazolam group); however single blind study (only assessors were blind) and ITT was not performed - per protocol analysis instead

7

Luhman 2001152: stated that not clinically apparent aspiration occurred in any patient

8

Luhman 2001152: stated that no cardio respiratory adverse events occurred in any patient at any time

9

Luhman 2001152: no incidents of vomiting in any patient in either group were observed

From: 6, Drugs for sedation in infants, children and young people

Cover of Sedation in Children and Young People
Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet].
NICE Clinical Guidelines, No. 112.
National Clinical Guideline Centre (UK).
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