Journal Article

Randomised placebo-controlled trial of triclofos versus melatonin for sedating children undergoing sleep EEG

Kohli, Sarvesh, Adhikari, Krishna Moorthi, Jha, Ruchika, Badal, Sachendra, Sondhi, Vishal, Ahmad, Faiz MH, Mohanan, Priyamol T, Kurup, Arjun, Devgan, Amit

2025

Overview

ObjectiveTo determine the efficacy of addition of melatonin or triclofos to sleep deprivation as compared with sleep deprivation with placebo for conduct of successful sleep electroencephalogram (EEG) among children between 6 months and 12 years of age.Design, setting and Patients486 children aged between 6 months and 12 years who were uncooperative or referred for sleep EEG were enrolled for this double-blind, placebo-controlled randomised trial between 30 June 2022 and 31 March 2023.InterventionOn the day of sleep EEG, participants were sleep deprived by 25% of their regular sleep duration and then randomly assigned to receive either triclofos (50 mg/kg), melatonin (weight ≤15 kg=3 mg; weight >15 kg=6 mg) or placebo.OutcomePrimary outcome was the conduct of a successful sleep EEG.Results486 children were randomly assigned to intervention with triclofos (n=165), melatonin (n=161) or placebo (n=160). Sleep EEG success (p<0.001) with different interventions was: triclofos=145/165(88%); melatonin=123/161 (76%) and placebo=65/160 (41%). Sleep EEG’s success rate was better with triclofos than melatonin (OR=2.2; 95% CI 1.2 to 4.1) or placebo (OR=10.6; 95% CI 6.1 to 19.0). Melatonin was better than placebo in the rate of successful sleep EEG (OR=4.7; 95% CI 2.9 to 7.7). Beta artefacts were significantly more with triclofos (51/145) than melatonin (19/123) and placebo (12/65), but the readability of EEG was not impacted. Movement/unwanted arousal artefacts were significantly more with placebo (37/65) than with triclofos (37/145) and melatonin (34/123). Drug-related adverse events were comparable between triclofos and melatonin. Neither of the drugs was associated with any serious adverse events.ConclusionsBoth triclofos and melatonin are individually better than sleep deprivation alone for conducting successful sleep EEGs. Triclofos is significantly better than melatonin for conducting sleep EEGs, with no significant increase in adverse events.Trial registration numberCTRI/2022/05/042479; Clinical Trials Registry of India

• Publisher: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health,BMJ Publishing Group LTD
• Subject: Adverse events / Anesthesia / Armed forces / Arousal / Caregivers / Child / Child, Preschool / Children / Children & youth / Childrens health / Clinical trials / Computation / Double-Blind Method / Drug dosages / EEG / Electroencephalography / Electroencephalography - methods / Epilepsy / Female / Guidelines / Humans / Infant / International Organizations / Intervention / Male / Melatonin / Melatonin - administration & dosage / Melatonin - therapeutic use / Military Schools / Neurology / Original research / Outcomes of Treatment / Paediatrics / Patients / Pediatrics / Placebo effect / Placebos / Sample Size / Sleep / Sleep - drug effects / Sleep deprivation / Sleep Deprivation - drug therapy / Statistical Analysis / Treatment Outcome