Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Jason Reynolds, Baylor College of Medicine Identifier:
First received: November 18, 2010
Last updated: January 27, 2015
Last verified: January 2015

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).

Condition Intervention Phase
Drug: Dexmedetomidine
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Time to complete study [ Time Frame: 60-180 minutes ] [ Designated as safety issue: No ]
    Time from medication administration to study completion.

Enrollment: 90
Study Start Date: August 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Oral Chloral and intranasal placebo
Drug: Dexmedetomidine
Intranasal dexmedetomidine 3mcg/kg
Active Comparator: Arm 2
oral placebo and intranasal dexmedetomidine
Drug: Dexmedetomidine
Intranasal dexmedetomidine 3mcg/kg
Active Comparator: Arm 3
intranasal dexmedetomidine and oral placebo
Drug: Dexmedetomidine
Intranasal dexmedetomidine 3mcg/kg
Active Comparator: Arm 4
intranasal placebo and oral chloral hydrate
Drug: Dexmedetomidine
Intranasal dexmedetomidine 3mcg/kg


Ages Eligible for Study:   6 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01255904

United States, Texas
Texas Childrens Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Jason Reynolds, Assistant Professor of Pediatrics, Baylor College of Medicine Identifier: NCT01255904     History of Changes
Other Study ID Numbers: H-27453
Study First Received: November 18, 2010
Last Updated: January 27, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chloral Hydrate
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 01, 2015