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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: April 12, 2016
Last verified: April 2016
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: Chloral Hydrate
Drug: Dexmedetomidine
Other: Oral placebo
Other: Intranasal placebo
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
Experimental: Arm 1
Oral Chloral and intranasal placebo
Drug: Chloral Hydrate
Oral chloral hydrate 50 mg/kg
Other: Intranasal placebo
Intranasal saline administered
Experimental: Arm 2
oral placebo and intranasal dexmedetomidine
Drug: Dexmedetomidine
Intranasal dexmedetomidine 3 mcg/kg
Other: Oral placebo
Oral saline administered


Ages Eligible for Study:   6 Months to 8 Years   (Child)
Genders Eligible for Study:   All
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
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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

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
Results First Received: January 25, 2016
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on January 14, 2017