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NCT01255904 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01255904
Other study ID # H-27453
Secondary ID
Status Completed
Phase Phase 4
First received November 18, 2010
Last updated January 25, 2016
Start date August 2011
Est. completion date November 2014

Study information
Verified date January 2016
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 8 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
Intranasal dexmedetomidine 3mcg/kg

Locations
Country Name City State
United States Texas Childrens Hospital Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Complete Study Time from medication administration to study completion. 60-180 minutes No
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