Efficacy of triclofos versus melatonin on sleep electroencephalography recording in children: a randomised controlled trial
Abstract
Background: EEG is an essential investigation for suspected epilepsy in children. As sleep EEG recordings are often difficult to obtain because of anxiety and poor cooperation, sedatives that safely induce physiological sleep without altering EEG findings are needed. The objective of this study was to compare the efficacy and safety of triclofos and melatonin for sleep induction during EEG recording in children aged 1-10 years.
Methods: In this randomized study, 100 children requiring medication for sleep EEG were assigned by block randomization to receive either oral triclofos (50 mg/kg) or melatonin (3-6 mg). Parents were instructed to wake their children at 4:00 a.m. and ensure at least 4 hours of sleep deprivation before EEG recording. The sedative was administered 30 minutes before the procedure, and EEG recording was initiated once the child fell asleep.
Results: Fifty children were enrolled in each group. Baseline characteristics were comparable, with mean ages of 4.92 ± 2.17 years in the triclofos group and 5.87 ± 1.77 years in the melatonin group. Mean sleep onset latency was significantly shorter with triclofos than melatonin (45.72 ± 14.90 vs. 59.70 ± 12.34 minutes; p < 0.001). Sleep duration and need for a second dose were similar between groups. Abnormal EEG findings were detected in 62% of children receiving triclofos and 54% receiving melatonin (p = 0.41). Excessive beta activity was more frequent with triclofos (62% vs. 24%). Adverse effects occurred in 16%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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