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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255904
First Posted: December 8, 2010
Last Update Posted: May 16, 2016
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.
Information provided by (Responsible Party):
Jason Reynolds, Baylor College of Medicine
  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
Sedation Drug: Chloral Hydrate Drug: Dexmedetomidine Other: Oral placebo Other: Intranasal placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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:


Further study details as provided by Jason Reynolds, Baylor College of Medicine:

Primary Outcome Measures:
  • Time to Complete Study [ Time Frame: 60-180 minutes ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01255904


Locations
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
ClinicalTrials.gov Identifier: NCT01255904     History of Changes
Other Study ID Numbers: H-27453
First Submitted: November 18, 2010
First Posted: December 8, 2010
Results First Submitted: January 25, 2016
Results First Posted: February 22, 2016
Last Update Posted: May 16, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Dexmedetomidine
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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


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