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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
November 18, 2010
December 8, 2010
January 25, 2016
February 22, 2016
May 16, 2016
August 2011
November 2014   (Final data collection date for primary outcome measure)
Time to Complete Study [ Time Frame: 60-180 minutes ]
Time from medication administration to study completion.
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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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Sedation
  • Drug: Chloral Hydrate
    Oral chloral hydrate 50 mg/kg
  • Drug: Dexmedetomidine
    Intranasal dexmedetomidine 3 mcg/kg
  • Other: Oral placebo
    Oral saline administered
  • Other: Intranasal placebo
    Intranasal saline administered
  • Experimental: Arm 1
    Oral Chloral and intranasal placebo
    Interventions:
    • Drug: Chloral Hydrate
    • Other: Intranasal placebo
  • Experimental: Arm 2
    oral placebo and intranasal dexmedetomidine
    Interventions:
    • Drug: Dexmedetomidine
    • Other: Oral placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 8 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01255904
H-27453
Yes
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Jason Reynolds, Baylor College of Medicine
Baylor College of Medicine
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Not Provided
Baylor College of Medicine
April 2016

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