• Br J Anaesth · Jan 2024

    Randomized Controlled Trial Multicenter Study

    The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia.

    • Robert Bolt, Marie C Hyslop, Esther Herbert, Diana E Papaioannou, Nikki Totton, Matthew J Wilson, Janet Clarkson, Christopher Evans, Nicholas Ireland, Jennifer Kettle, Zoe Marshman, Amy C Norrington, Robert H Paton, Christopher Vernazza, Christopher Deery, and MAGIC collaborative.
    • School of Clinical Dentistry, University of Sheffield, Sheffield, UK.
    • Br J Anaesth. 2024 Jan 1; 132 (1): 768576-85.

    BackgroundChild anxiety before general anaesthesia and surgery is common. Midazolam is a commonly used premedication to address this. Melatonin is an alternative anxiolytic, however trials evaluating its efficacy in children have delivered conflicting results.MethodsThis multicentre, double-blind randomised trial was performed in 20 UK NHS Trusts. A sample size of 624 was required to declare noninferiority of melatonin. Anxious children, awaiting day case elective surgery under general anaesthesia, were randomly assigned 1:1 to midazolam or melatonin premedication (0.5 mg kg-1, maximum 20 mg) 30 min before transfer to the operating room. The primary outcome was the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Secondary outcomes included safety. Results are presented as n (%) and adjusted mean differences with 95% confidence intervals.ResultsThe trial was stopped prematurely (n=110; 55 per group) because of recruitment futility. Participants had a median age of 7 (6-10) yr, and 57 (52%) were female. Intention-to-treat and per-protocol modified Yale Preoperative Anxiety Scale-Short Form analyses showed adjusted mean differences of 13.1 (3.7-22.4) and 12.9 (3.1-22.6), respectively, in favour of midazolam. The upper 95% confidence interval limits exceeded the predefined margin of 4.3 in both cases, whereas the lower 95% confidence interval excluded zero, indicating that melatonin was inferior to midazolam, with a difference considered to be clinically relevant. No serious adverse events were seen in either arm.ConclusionMelatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias.Clinical Trial RegistrationISRCTN registry: ISRCTN18296119.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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