CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT01255904
NCT01255904Phase 4Completed

A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.

Baylor College of Medicine·interventional·Posted Dec 8, 2010·Updated May 16, 2016

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 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