At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 90 enrolled
Drug / intervention
Chloral Hydrate +3 moredrug
Likely dose
Chloral Hydrate 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.
In Brief
A Phase 4 clinical trial evaluating Chloral Hydrate, Dexmedetomidine, and 2 other interventions for Sedation. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartAug 2011
Primary CompletionNov 2014
TodayJul 2026
First PostedDec 8, 2010
Enrollment StartAug 1, 2011
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.6 years ago
Interventions
Chloral Hydratedrug
Oral chloral hydrate 50 mg/kg
Dexmedetomidinedrug
Intranasal dexmedetomidine 3 mcg/kg
Oral placeboother
Oral saline administered
Intranasal placeboother
Intranasal saline administered