Five trials with 336 children were included in the oral midazolam versus chloral hydrate comparison. There was no difference in discomfort (RR 0.51 95% CI 0.25 to 1.04 I 2 = 0% 2 studies 190 adults). Risk of difficulty performing procedures was lower in the midazolam group (RR 0.5 95% CI 0.29 to 0.86 I 2 = 45% 3 studies 191 adults and 32 children). There was no difference in anxiety (RR 0.43, 95% CI 0.09 to 1.99 I 2 = 75% 2 studies 123 adults). Midazolam resulted in a higher level of sedation than placebo (mean difference (MD) 1.05 95% confidence interval (95% CI) 0.69 to 1.41 1 study 100 adults). Effect estimates for all outcomes within the intravenous midazolam versus placebo (7 trials 633 adults and 32 children) are uncertain due to concerns about imprecision and risk of bias.
ResultsĮight new trials were included in this update, which resulted in changed conclusions for the intravenous midazolam versus placebo, oral midazolam versus chloral hydrate and oral midazolam versus placebo comparisons. Two authors independently extracted data and assessed risk of bias for each included study. Randomized controlled trials of midazolam in comparison with placebo or other medications used for sedation were included. We searched CENTRAL, MEDLINE, Embase and two trials registers up to May 2020 together with reference checking to identify additional studies.
This is an update of a Cochrane review published in 2016, which aimed to determine the evidence on the effectiveness of midazolam for sedation when administered before a diagnostic or therapeutic procedure in adults and children. Midazolam is used for sedation before diagnostic and therapeutic medical procedures by several routes including oral, intravenous, intranasal and intramuscular.
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