Comparison of Efficacy and Safety of Intranasal Midazolam with Syrup Chloral Hydrate for Procedural Sedation

Abstract

Objectives:

Evaluate the efficacy and safety of intranasal midazolam and syrup chloral hydrate for procedural sedation in children.

Methods:

A prospective, randomized, double-blinded placebo controlled trial, in a tertiary care hospital over 18 months. A total of 82 children, ages 1 to 6 years, undergoing auditory brainstem response testing, were randomized to receive either midazolam nasal spray with oral placebo or syrup chloral hydrate with placebo nasal spray. Midazolam at 0.5 mg/kg delivered as 100 mcg per spray and oral syrup at a dose of 50 mg/kg. Children not sedated at 30 minutes had a second dose at half the initial dose. The primary outcomes measured were safety and efficacy. Secondary outcomes were time to onset of sedation, parental separation, nature of parental separation, parental satisfaction, audiologists satisfaction, time to recovery, and number of attempts.

Results:

There were 41 children in each group. No major adverse events noted. The chloral hydrate group showed earlier onset of sedation (66%) compared with midazolam group (33%). A significant difference in the time to recovery in the chloral hydrate (78 min) group compared with the midazolam group (108 min). Parental and audiologist satisfaction was higher for chloral hydrate (95 % and 75%) than for midazolam (49% and 29%). Overall, sedation with chloral hydrate was 95% compared with 51% with midazolam. Both the drugs maintained sedation.

Conclusions:

Both intranasal midazolam and oral chloral hydrate are safe and efficacious for pediatric procedural sedation. Chloral hydrate was superior to intranasal midazolam with an earlier time to onset of sedation, a faster recovery, better parental and audiologist satisfaction, and successful sedation.