A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: Chloral Hydrate; Drug: Dexmedetomidine; Other: Intranasal placebo; Other: Oral placebo

• Registration Number: NCT01255904
• Lead Sponsor: Baylor College of Medicine

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Study Start: 2011-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-01-25
• Results First Submitted QC: 2016-01-25
• Results First Posted: 2016-02-22
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.

Exclusion Criteria

• Patients younger than 6 months or older than 8 years
• Previously failed sedation
• Weight greater than 25 kg
• Weight less than 5 kg
• BMI above 30
• Diagnosis of ADHD
• Any patient deemed inappropriate for nurse administered sedation
• Patients with any cardiac disease
• Obstructive sleep apnea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Intranasal placebo	Oral Chloral and intranasal placebo
Arm 1	Chloral Hydrate	Oral Chloral and intranasal placebo
Arm 2	Oral placebo	oral placebo and intranasal dexmedetomidine
Arm 2	Dexmedetomidine	oral placebo and intranasal dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Time to Complete Study	60-180 minutes	Time from medication administration to study completion.

Trial Locations

Locations (1)

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States