Effect of Triclofos versus Melatonin on sleep EEG recording- A Prospective Randomised controlled study

Objectives To compare the effect of triclofos versus melatonin on sleep EEG recording for children between 1 -10 years of age. Methods Hundred children (1-10 years) referred for sleep EEG and required medication for induction of sleep were enrolled and were randomly assigned in two groups of triclofos and melatonin for sedation using block randomisation. Parents were asked to awaken their children at 4.00 am and not to let them fall asleep until the time of EEG recording. Informed consent was obtained from the parents. Triclofos and melatonin in the dose of 50mg/kg/dose and 3–6 mg respectively were given orally 30 minutes before EEG performance and EEGs were recorded 0.5–1 h after the sedative administration immediately when the child fell asleep to provide a similar condition for both groups. Results Baseline characteristics were comparable in the two groups. A total of 100 children (male to female ratio of 1.9:1) were enrolled with 50 patients in each group of triclofos(mean age 4.92±2.17) and melatonin(mean age 5.87±1.77). The mean sleep onset latency(minutes) was 45.72±14.90 in triclofos group compared to 59.70±12.34 in melatonin groups (p<0.001). However, sleep duration and requirement of second dose were comparable in both the group. Abnormal EEG was seen in 46% in triclofos group compared to 54% in melatonin group.

Conclusion Both triclofos and melatonin were equally effective drugs for the recording of sleep EEGs in the pediatric population with no major adverse event with sleep onset latency better with triclofos.
Keywords: Triclofos, Melatonin, EEG, sleep