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Abstract
Objective To 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 Patients 486 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.
Intervention On 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.
Outcome Primary outcome was the conduct of a successful sleep EEG.
Results 486 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.
Conclusions Both 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 number CTRI/2022/05/042479; Clinical Trials Registry of India
- Neurology
- Paediatrics
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. Not Applicable.
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Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. Not Applicable.
Footnotes
Contributors VS is the guarantor of this work and takes responsibility for the data’s integrity and the data analysis’s accuracy. VS conceptualised and designed the study. PTM, RJ, AK, SK SB, and FMHA researched data. PTM, RJ and VS wrote the first draft of the manuscript. KMA, FMHA and AD contributed to the discussion and reviewed and edited the manuscript. PTM and VS performed the statistical analysis. RJ and VS reviewed and edited the manuscript. All authors approved the final version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer-reviewed.
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