OBJECTIVE: To compare the success rate of auditory brainstem response (ABR) testing after the application of melatonin niosome gel (MNG) versus chloral hydrate in children aged 1 to 6 years.

METHODS: A double-blinded, randomized, controlled trial was conducted. Participants in the MNG group were given 250 mg of MNG (5 mg melatonin) for sedation prior to the ABR test, and those in the chloral hydrate group were given chloral hydrate syrup, 50 mg/kg with an additional dose of 25 mg/kg if they didn’t fall asleep within 30 min. The study was conducted in the morning; all the participants were prepared in accordance with protocols similar to the regular ABR protocols.

RESULTS: Twenty-four children were enrolled, and 16 participants passed the screening and were randomized into 2 groups. The success rate of ABR in the MNG group was 25.0% compared to 100.0% in the chloral hydrate group (p-value = 0.01). Twenty-five percent of the subjects in the chloral hydrate group required a second dose of choral hydrate. The average sleep onset latency of the chloral hydrate group was 25.1 min, which was approximately the same as the MNG group (25.4 min). The average sleep duration of the chloral hydrate group was 89.3 min, which was significantly longer than the MNG group (45.6 min), with a mean difference of 43.6 min (p-value = 0.01). There were minor adverse events in both groups, including vomiting (12.5 – 25.0%) and irritability (25.0%), without any serious adverse events reported.

CONCLUSION: The sedative effect of trans-mucosal MNG was unfavorable comparing with the chloral hydrate. The sublingual delivery was intolerance for uncooperative children and sedation for neurodevelopment disordered children were challenging. However, the sleep onset latency by behavioral observation induced by MNG tended to be comparable to chloral hydrate. Further adjustment of trans-mucosal administration and dosage could provide adequate pediatric sedation.