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Randomised placebo-controlled trial of triclofos versus melatonin for sedating children undergoing sleep EEG
Priyamol T Mohanan1, Ruchika Jha1, Arjun Kurup1
1Pediatrics, Armed Forces Medical College, Pune, Maharashtra, India.
Insights
Triclofos and melatonin improve sleep electroencephalogram (EEG) success rates in children compared to placebo after sleep deprivation. Triclofos demonstrated superior efficacy over melatonin for successful sleep EEG conduct.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Clinical Trials
Background:
- Conducting successful sleep electroencephalograms (EEGs) in children can be challenging.
- Sleep deprivation is often used to facilitate sleep EEGs but may require adjuncts.
- Evaluating the efficacy of pharmacological agents to improve sleep EEG success is crucial.
Purpose of the Study:
- To compare the efficacy of melatonin and triclofos, when added to sleep deprivation, versus placebo for successful sleep EEG in children.
- To assess the success rates of sleep EEGs under different intervention conditions.
Main Methods:
- A double-blind, placebo-controlled randomized trial was conducted with 486 children aged 6 months to 12 years.
- Participants underwent 25% sleep deprivation before receiving triclofos, melatonin, or placebo.
- The primary outcome was the successful conduct of a sleep EEG.
Main Results:
- Sleep EEG success rates were significantly higher with triclofos (88%) and melatonin (76%) compared to placebo (41%).
- Triclofos showed significantly better success rates than melatonin (OR=2.2) and placebo (OR=10.6).
- Adverse events were comparable between triclofos and melatonin, with no serious events reported.
Conclusions:
- Both triclofos and melatonin are effective adjuncts to sleep deprivation for achieving successful sleep EEGs in children.
- Triclofos is more effective than melatonin for sleep EEG success without increasing adverse events.
- These findings support the use of triclofos and melatonin in pediatric sleep studies.
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.
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