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Lookup NU author(s): Professor Chris VernazzaORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2023 The Author(s)Background: Child 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. Methods: This 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. Results: The 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. Conclusion: Melatonin 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 registration: ISRCTN registry: ISRCTN18296119.
Author(s): Bolt R, Hyslop MC, Herbert E, Papaioannou DE, Totton N, Wilson MJ, Clarkson J, Evans C, Ireland N, Kettle J, Marshman Z, Norrington AC, Paton RH, Vernazza C, Deery C, Albadri S, Armstrong L, Atkins S, Babb M, Biercamp C, Biggs K, Bradburn M, Buckley J, Child-Cavill J, Cope S, Crawley S, Dimairo M, Duro E, Eissa A, Flight L, Gath J, Gavel G, Geary T, Gilchrist F, Gopal P, Hall J, Hutchence K, Khandelwal P, Kukreja P, Leeuwenberg I, Limb J, Loban A, Mellor K, Masip N, Moores A, Oshan V, Pickles E, Ray J, Rodd H, Rolfe S, Sheldon E, Simmonds R, Smith R, Sundar A, Thomason A, Waterhouse S, Wilson G, Yates J, Young T
Publication type: Article
Publication status: Published
Journal: British Journal of Anaesthesia
Year: 2023
Volume: 132
Issue: 1
Pages: 76-85
Online publication date: 10/11/2023
Acceptance date: 11/10/2023
Date deposited: 28/11/2023
ISSN (print): 0007-0912
ISSN (electronic): 1471-6771
Publisher: Elsevier Ltd
URL: https://doi.org/10.1016/j.bja.2023.10.011
DOI: 10.1016/j.bja.2023.10.011
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