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A prospective, randomized, double‐blind trial of intranasal dexmedetomidine and oral chloral hydrate for sedated auditory brainstem response ( ABR ) testing
Author(s) -
Reynolds Jason,
Rogers Amber,
Medellin Eduardo,
Guzman Jonathan A.,
Watcha Mehernoor F.
Publication year - 2016
Publication title -
pediatric anesthesia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.704
H-Index - 82
eISSN - 1460-9592
pISSN - 1155-5645
DOI - 10.1111/pan.12854
Subject(s) - medicine , dexmedetomidine , anesthesia , chloral hydrate , sedation , placebo , randomized controlled trial , sedative , adverse effect , auditory brainstem response , surgery , hearing loss , alternative medicine , pathology , audiology
Summary Background Dexmedetomidine is increasingly used by various routes for pediatric sedation. However, there are few randomized controlled trials comparing the efficacy of dexmedetomidine to other commonly used sedatives. Aim To compare the efficacy of sedation with intranasal dexmedetomidine to oral chloral hydrate for auditory brainstem response ( ABR ) testing. Methods In this double‐blind, double‐dummy study, children undergoing ABR testing were randomized to receive intranasal dexmedetomidine 3 mcg·kg −1 plus oral placebo (Group IN DEX ) or oral chloral hydrate 50 mg·kg −1 plus intranasal saline placebo (Group CH ). We recorded demographic data, times from sedative administration to start and completion of testing, quality of sedation, occurrence of predefined adverse events, discharge times, and return to baseline activity on the day of testing. Results Testing completion rates with a single dose of medication were higher in the IN DEX group (89% vs 66% for CH , odds ratio with 95% confidence intervals 4.04 [1.3–12.6], P = 0.018). The median [95% CI )] time to successful testing start was shorter (25 [20–29] min vs 30 [20–49] min for IN DEX and CH , respectively, log rank test P = 0.02) and the proportion of children whose parents reported a return to baseline activity on the day of testing was greater for the IN DEX than the CH group (89% vs 64%, OR [95% CI ] 4.71 [1.34–16.6], P = 0.02). There were no major adverse events in either group and no significant differences in the incidence of minor events. Conclusion Intranasal dexmedetomidine is an effective alternative to oral chloral hydrate sedation for ABR testing, with the advantages of a higher incidence of testing completion with a single dose, shorter time to desired sedation level, and with significantly more patients reported to return to baseline activity on the same day.