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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Reynolds, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01255904
First received: November 18, 2010
Last updated: April 12, 2016
Last verified: April 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 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

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years   (Child)
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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 
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:
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

ClinicalTrials.gov processed this record on September 29, 2016