Comparative Study of Oral Midazolam vs. Oral Melatonin for Pre-Operative Anxiolysis in Paediatric Patients

Abstract

Dr. Raghunath S. S

BACKGROUND Clinical trials with melatonin as a pre-medication agent in anxious children under nitrous oxide oxygen sedation for dental treatment have shown good results; but so far, only limited data is available. Midazolam is a benzodiazepine which produces anxiolytic, amnestic, hypnotic and skeletal muscle relaxant effects. We wanted to compare oral midazolam (0.5 mg/Kg) versus oral melatonin (0.5 mg/Kg) as a premedication in paediatric patients aged 1-6 years with regard to sedation and anxiolysis. METHODS This is a prospective, randomised double blind clinical study in which sixty children of ASA I and II in the age group 1-6 years, scheduled for elective general surgeries were included who were randomly allocated to two groups that would receive either 0.5 mg/Kg of oral midazolam or 0.5 mg/Kg of oral melatonin. The children were evaluated for sedation, anxiolysis, parental separation anxiety and acceptance of mask at induction. RESULTS Midazolam and melatonin were well accepted by the children. The quality and onset of sedation were similar in both the groups. The quality of anxiolysis is significantly better in the midazolam group, and the onset is earlier which is statistically significant. Melatonin group had a delayed onset and quality of anxiolysis was satisfactory and comparable to midazolam. The quality of parental separation and quality of mask acceptance was statistically insignificant in both the groups. CONCLUSIONS Oral melatonin can be an alternative premedication for sedation-anxiolysis in children. Oral midazolam had earlier onset and superior quality of sedation-anxiolysis compared to oral melatonin in the doses compared.

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