Table 11Oral midazolam + nitrous oxide vs. nitrous oxide + placebo; Luhman 2001152

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

Settings: accidents and emergencies

Bibliography: Luhman 2001152 (suturing and laceration repairs)

Quality assessmentSummary of findingsImportance
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsoral midazolam plus nitrous oxide plus analgesianitrous oxide plus placebo plus analgesiaRelative (95% CI)Absolute
Completion of procedure
1randomised trialserious1no serious inconsistencyno serious indirectnessno serious imprecision2none52/52 (100%)51/51 (100%)RR=11000 fewer per 1000 (from 1000 fewer to 1000 fewer)MODERATE
0 fewer per 1,000
Adverse events: Aspiration
1randomised trialserious1no serious inconsistencyno serious indirectnessno serious imprecisionnone0/52 (0%)30/51 (0%)not pooled-MODERATE
Adverse events: Respiratory intervention
1randomised trialserious1no serious inconsistencyno serious indirectnessno serious imprecisionnone0/52 (0%)40/51 (0%)not pooled-MODERATE
Adverse events: Vomiting
1randomised trialserious1no serious inconsistencyno serious indirectnessserious5none1/52 (1.9%)5/51 (9.8%)RR 0.20 (0.02 to 1.62)678 fewer per 1000 (from 96 fewer to 61 more)LOW
0 fewer per 1,000
1

Luhman 2001152: adequate concealment and low loss of follow up; however single blind study (only assessors were blind) and ITT was not performed

2

Luhman 2001152: not estimable, all patients completed the procedure

3

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

4

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

5

Luhman 2001152: wide confidence intervals

6

Luhman 2001152: p=0.13

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.
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