Status:
COMPLETED
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Lead Sponsor:
Baylor College of Medicine
Conditions:
Sedation
Eligibility:
All Genders
6-8 years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01255904
Start Date
August 1 2011
End Date
November 1 2014
Last Update
May 16 2016
Active Locations (1)
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1
Texas Childrens Hospital
Houston, Texas, United States, 77030