• Otolaryngol Head Neck Surg · Dec 2015

    Randomized Controlled Trial Comparative Study

    A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children.

    • Marie Christy Sharafine Stephen, John Mathew, Ajoy Mathew Varghese, Mary Kurien, and George Ani Mathew.
    • Department of Otolaryngology, Speech, and Hearing, Christian Medical College, Vellore, India sharafine@gmail.com.
    • Otolaryngol Head Neck Surg. 2015 Dec 1; 153 (6): 1042-50.

    ObjectivesTo evaluate the efficacy and safety of intranasal midazolam and chloral hydrate syrup for procedural sedation in children.Study DesignProspective randomized placebo-controlled trial (double blind, double dummy).SettingTertiary care hospital over 18 months.Subjects And MethodsEighty-two children, 1 to 6 years old, undergoing auditory brainstem response testing were randomized to receive either intranasal midazolam with oral placebo or chloral hydrate syrup with placebo nasal spray. Intranasal midazolam was delivered at 0.5 mg/kg (100 mcg per spray) and oral syrup at 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, audiologist's satisfaction, time to recovery, and number of attempts.ResultsForty-one children were in each group, and no major adverse events were noted. The chloral hydrate group showed earlier onset of sedation (66%) compared with the intranasal midazolam group (33%). Significant difference in time to recovery was noted in the chloral hydrate group (78 minutes) versus the intranasal midazolam group (108 minutes). The parents' and audiologist's satisfaction was higher for chloral hydrate (95% and 75%) than for intranasal midazolam (49% and 29%, respectively). Overall, sedation was 95% with chloral hydrate versus 51% with intranasal midazolam. Both drugs maintained sedation.ConclusionsIntranasal midazolam and chloral hydrate are both 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 satisfaction among parents and the audiologist, and successful sedation.© American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

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