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

November 18, 2010
December 7, 2010
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Complete list of historical versions of study NCT01255904 on ClinicalTrials.gov Archive Site
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A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.

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).

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Moderate Sedation
Drug: Dexmedetomidine
Intranasal dexmedetomidine 3mcg/kg
  • Active Comparator: Arm 1
    Oral Chloral and intranasal placebo
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Arm 2
    oral placebo and intranasal dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Arm 3
    intranasal dexmedetomidine and oral placebo
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Arm 4
    intranasal placebo and oral chloral hydrate
    Intervention: Drug: Dexmedetomidine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
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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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Both
6 Months to 8 Years
No
United States
 
NCT01255904
H-27453
Yes
Jason Reynolds / Assistant Professor of Pediatrics and Anesthesiology, Baylor College of Medicine
Baylor College of Medicine
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Baylor College of Medicine
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP