A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
February 22, 2016
CompletedMay 16, 2016
April 1, 2016
3.3 years
November 18, 2010
January 25, 2016
April 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Complete Study
Time from medication administration to study completion.
60-180 minutes
Study Arms (2)
Arm 1
EXPERIMENTALOral Chloral and intranasal placebo
Arm 2
EXPERIMENTALoral placebo and intranasal dexmedetomidine
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Childrens Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
PMID: 34397100DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was not designed to detect small differences in rare adverse and the overall safety of either medication cannot be assessed based on these results alone.
Results Point of Contact
- Title
- Jason Reynolds
- Organization
- Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
November 18, 2010
First Posted
December 8, 2010
Study Start
August 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 16, 2016
Results First Posted
February 22, 2016
Record last verified: 2016-04