• Takahiro Mihara, Nobuhito Nakamura, Koui Ka, Mari S Oba, and Takahisa Goto.
• From the Department of Anaesthesiology, Kanagawa Children's Medical Centre (TM, NN), Department of Biostatistics and Epidemiology, Yokohama City University (MSO), and Department of Anaesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan (TG).
• Eur J Anaesthesiol. 2015 Dec 1; 32 (12): 862-71.

BackgroundEmergence agitation is a common phenomenon in children recovering from general anaesthesia. An emergence agitation reaction increases the risk of injuring the surgical repair, the patient and the caregivers.ObjectiveThe objective of this study is to examine the efficacy of melatonin premedication in emergence agitation prevention.DesignA systematic review and meta-analysis of randomised controlled trials (RCTs) with trial sequential analysis (TSA) and meta-regression analysis.Data SourcesWe searched MEDLINE, the Cochrane Central Register of Controlled Trials, Embase, Web of Science, clinicaltrials.gov and UMIN Clinical Trials Registry up to 4 April 2014.Eligibility CriteriaRCTs reporting effects of melatonin on the incidence of emergence agitation in children who underwent general anaesthesia were included.ResultsFour studies (358 participants) were analysed. A conventional random-effects meta-analysis showed that compared with placebo, melatonin premedication may be effective in emergence agitation prevention [risk ratio 0.31, 95% confidence interval (CI) 0.16 to 0.60; I2 = 0%]. However, TSA corrected the 95% CI to 0.07 to 1.47 and showed that 22.5% of the required information size (RIS) was achieved. The effect of melatonin compared with that of midazolam was not statistically significant (risk ratio 0.48, 95% CI 0.15 to 1.52) with significant heterogeneity (I2 = 36.8%). TSA-adjusted 95% CI could not be calculated because of the small information size (4% of RIS). Meta-regression showed that, compared with midazolam, melatonin dose was significantly correlated with the effect (P = 0.024). The risk ratios (95% CI) of low and high-dose melatonin were 1.02 (0.39 to 2.65) and 0.22 (0.08 to 0.58), respectively. There was no effect of melatonin compared with dexmedetomidine (risk ratio 1.0, 95% CI 0.15 to 6.55). TSA-adjusted 95% CI could not be calculated (0.9% of RIS).ConclusionCompared with placebo, melatonin premedication may be effective in preventing emergence agitation in children (GRADE: low). This TSA suggests that further studies are required to confirm the results. Compared with midazolam, high-dose melatonin might have a significant effect in preventing emergence agitation (GRADE: very low). The study protocol was registered in the UMIN Clinical Trials Registry (registration number: UMIN000011841).

This article appears in the collection: Avoiding post-anesthesia emergence delirium in children.

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