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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01255904
First received: November 18, 2010
Last updated: December 7, 2010
Last verified: December 2010
History of Changes
  Purpose

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
Moderate Sedation
 Drug: Dexmedetomidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment: 90
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

  Eligibility

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

Inclusion Criteria:(1) Age greater than 6 months and less than 8 years. (2) Scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.

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Exclusion Criteria:(1) Patients younger than 6 months or older than 8 years (2) Previously failed sedation. (3) Weight greater than 25 kg. (4) Weight less than 5 kg (5) BMI above 30. (6) Diagnosis of ADHD. (7) Any patient deemed inappropriate for nurse administered sedation per TCH Policy (see attached screening criteria in addendum). (8) Patients with any cardiac disease. (9) Sleep apnea

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255904

Locations
United States, Texas
Texas Childrens Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jason Reynolds, MD     832-824-5800     jmreynol@bcm.edu    
Sponsors and Collaborators
Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Jason Reynolds / Assistant Professor of Pediatrics and Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01255904     History of Changes
Other Study ID Numbers: H-27453
Study First Received: November 18, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chloral Hydrate
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
 Analgesics
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

ClinicalTrials.gov processed this record on May 22, 2013