OBJECTIVES : To explore the efficacy and safety of midazolam oral solution for sedation and hypnosis in children.

METHODS : Relevant studies were identified through searches of PubMed, Embase (Ovid), Cochrane Library, CINAHL, International Pharmaceuticals, and four Chinese electronic databases. Two reviewers independently selected trials, assessed trial quality, and extracted the data.

RESULTS : Eighty-nine RCTs comparing midazolam oral solution with placebo or blank (n =33), dexmedetomidine (n = 15), ketamine (n = 11), different midazolam doses (n = 10), midazolam injection (n = 8), chloral hydrate (n = 7), diazepam (n = 5), N₂O (n = 5), triclofos (n = 4), butorphanol (n = 2), fentanyl (n = 2), hydroxyzine (n = 1), and thiopental (n = 1) were identified. Meta-analysis showed no significant difference in the success rate and duration of sedation and hypnosis between midazolam oral and injectable solution (P＞0.05). No significant difference was found in the success rate of sedation and hypnosis, mask acceptance and parental separation between midazolam oral solution and dexmedetomidine (P＞0.05), and the result of one cohort study was consistent. The results of RCTs and prospective cohort study showed the incidence of ADR was 19.57% (189/966). Incidence of ADR between (0.25, 0.5] mg/kg and (0.5, 1.0] mg/kg dose groups were similar [Pf (95% CI) =0.10(0.04, 0.24) and Pf (95% CI) =0.09(0.02, 0.39) respectively], higher than that of (0, 0.25] mg/kg dose group [Pf (95% CI) =0.01(0.00, 0.19)].

CONCLUSIONS : Available evidence suggests that midazolam oral solution is as good as midazolam injection and dexmedetomidine, and is better than ketamine. Based on efficacy and safety results, the dose of oral midazolam solution is recommended 0.5-1 mg/kg for children.