Context The literature on melatonin as a sedative agent in children is limited.
Objective To conduct a systematic review of studies assessing the efficacy and safety of melatonin for non-operating room sedation in children.
Methods Medline, Embase, Cochrane Library and Cumulative Index to Nursing and Allied Health were searched until 9 April 2020 for studies using melatonin and reporting one of the prespecified outcomes of this review. Two authors independently assessed the eligibility, risk of bias and extracted the data. Studies with a similar study design, comparator and procedure were pooled using the fixed-effect model.
Results 25 studies (clinical trials=3, observational studies=9, descriptive studies=13) were included. Melatonin was used for electroencephalogram (EEG) (n=12), brainstem evoked response audiometry (n=8) and magnetic resonance imaging (MRI) (n=5). No significant differences were noted on meta-analysis of EEG studies comparing melatonin with sleep deprivation (SD) (relative risk (RR) 1.06 (95% CI 0.99 to 1.12)), melatonin with chloral hydrate (RR 0.97 (95% CI 0.89 to 1.05)) and melatonin alone with melatonin and SD combined (RR 1.03 (95% CI 0.97 to 1.10)) for successful procedure completion. However, significantly higher sedation failure was noted in melatonin alone compared with melatonin and SD combined (RR 1.55 (95% CI 1.02 to 2.33)) for EEG. Additionally, meta-analysis showed lower sleep latency for melatonin compared with SD (mean difference −10.21 (95% CI −11.53 to −8.89) for EEG. No major adverse events were reported with melatonin.
Conclusion Although several studies were identified, and no serious safety concerns were noted, the evidence was not of high quality to establish melatonin’s efficacy for non-operating room sedation in children.
Data availability statement
All data relevant to the study are included in the article or uploaded as supplemental information.
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JA, WP and AR are joint first authors.
JA, WP and AR contributed equally.
Contributors JA conceptualised and designed the study, performed the initial screening of the articles, abstracted the data, performed meta-analyses including the risk of bias assessment, drafted the manuscript and approved the final version. WP co-conceptualised the study, double checked the initial screening of articles and double-checked all the data extraction from included studies, reviewed the study protocol and helped revise the manuscript and approved the final version. AKP co-conceptualised the study, performed the literature search, reviewed the study protocol and helped revise the manuscript and approved the final version. AR co-conceptualised and co-designed the study, supervised the co-investigators throughout the study, provided intellectual content, reviewed the study protocol and helped revise the manuscript and approved the final version. JA, WP and AR are joint first authors.
Funding This research was funded by the Deanship of Scientific Research at Princess Nourah Bint Abdulrahman University through the Fast track Research Funding Programme. The funder had no role in conceiving the study design, collection, analysis and interpretation of the data, and decision to publish the study.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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