• Lily Singla, Preethy J Mathew, Aditi Jain, Sandhya Yaddanapudi, and Nitin J Peters.
• From the Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Punjab, India (LS, PJM, AJ, SY, NJP).
• Eur J Anaesthesiol. 2021 Nov 1; 38 (11): 1130-1137.

BackgroundPre-operative anxiety is a risk factor for emergence delirium in children and a multimodal approach including sedatives and nonpharmacological measures is the current strategy to tackle this anxiety. The efficacy of oral melatonin as a component of multimodal anxiolytic strategy to decrease emergence delirium is not well studied.ObjectiveThe aim of this study was to evaluate the efficacy of a multimodal anxiolytic strategy including oral melatonin or midazolam to decrease emergence delirium after sevoflurane anaesthesia.DesignA randomised, double-blind, parallel arm, placebo-controlled trial.SettingTertiary care teaching hospital from July 2019 till January 2020.ParticipantsChildren in the age group of 3 to 8 years who received sevoflurane anaesthesia for elective ambulatory procedures.InterventionsChildren were randomised to receive oral premedication with either melatonin 0.3 mg kg-1, midazolam 0.3 mg kg-1 or honey as placebo. All the children received standardised nonpharmacological measures involving multiple techniques to allay anxiety. The anaesthetic plan was also standardised.Main Outcome MeasuresThe primary outcome was the incidence of emergence delirium as assessed by the Watcha scale in the postanaesthesia care unit. The secondary outcomes were pre-operative anxiety assessed using a modified Yale Preoperative Anxiety scale, patient compliance with mask induction using the Induction Compliance Checklist and postoperative sedation.ResultsData from 132 children were analysed. Melatonin significantly reduced the incidence of emergence delirium compared to placebo: 27 vs. 50%, respectively, an absolute risk reduction of 23.3 [95% confidence interval 3.7 to 42.9), P = 0.03]. Melatonin also significantly reduced the risk of emergence delirium compared with midazolam: 27 vs. 56%, respectively, an absolute risk reduction of 29.2 (95% CI 9.5 to 48.8). The midazolam group had a similar incidence of emergence delirium as placebo. Sedation scores were similar in the three groups postoperatively. The incidence and score of pre-operative anxiety as well as the compliance with mask induction were similar in the three groups.ConclusionsA multimodal anxiolytic approach including oral melatonin, as opposed to oral midazolam, significantly reduced emergence delirium after sevoflurane anaesthesia.Trial RegistrationCTRI/2019/06/019850 in Clinical Trial Registry of India (www.ctri.nic.in).Copyright © 2021 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.

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