title: A prospective, randomized, double-blind trial of intranasal dexmedetomidine and oral chloral hydrate for sedated auditory brainstem response (ABR) testing.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatrics, Section of Hospital Medicine, Baylor College of Medicine, Houston, TX, USA.|Department of Medicine, Section of Pediatric Hospital Medicine, Children's Hospital of San Antonio, San Antonio, TX, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Reynolds
authors.affiliation: Department of Pediatrics, Section of Hospital Medicine, Baylor College of Medicine, Houston, TX, USA.|Department of Pediatric Anesthesiology, Texas Children's Hospital, Houston, TX, USA.
authors.forename: Amber
authors.initials: A
authors.lastname: Rogers
authors.affiliation: Department of Pediatric Anesthesiology, Texas Children's Hospital, Houston, TX, USA.|Department of Anesthesiology, Section of Pediatric Anesthesiology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Medellin
authors.affiliation: Department of Pediatric Anesthesiology, Texas Children's Hospital, Houston, TX, USA.|Department of Anesthesiology, Section of Pediatric Anesthesiology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Guzman
authors.affiliation: Department of Pediatric Anesthesiology, Texas Children's Hospital, Houston, TX, USA.|Department of Anesthesiology, Section of Pediatric Anesthesiology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Mehernoor F
authors.initials: MF
authors.lastname: Watcha
mesh_terms: D000281:Administration, Intranasal; D000284:Administration, Oral; D002675:Child, Preschool; D002697:Chloral Hydrate / Q000008:administration & dosage / Q000494:pharmacology*; D020927:Dexmedetomidine / Q000008:administration & dosage / Q000494:pharmacology*; D004311:Double-Blind Method; D016057:Evoked Potentials, Auditory, Brain Stem / Q000187:drug effects*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000494:pharmacology*; D007223:Infant; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D006993:Hypnotics and Sedatives; D002697:Chloral Hydrate; D020927:Dexmedetomidine
keywords: administration; auditory; brainstem; chloral hydrate; dexmedetomidine; evoked potentials; hypnotics and sedatives; intranasal