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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255904
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : February 22, 2016
Last Update Posted : May 16, 2016
Information provided by (Responsible Party):
Jason Reynolds, Baylor College of Medicine

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).

Condition or disease Intervention/treatment Phase
Sedation Drug: Chloral Hydrate Drug: Dexmedetomidine Other: Oral placebo Other: Intranasal placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to Complete Study [ Time Frame: 60-180 minutes ]
    Time from medication administration to study completion.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255904

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

Responsible Party: Jason Reynolds, Assistant Professor of Pediatrics, Baylor College of Medicine Identifier: NCT01255904     History of Changes
Other Study ID Numbers: H-27453
First Posted: December 8, 2010    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: May 16, 2016
Last Verified: April 2016

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