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: January 27, 2015
Last verified: January 2015

November 18, 2010
January 27, 2015
August 2011
November 2014   (final data collection date for primary outcome measure)
Time to complete study [ Time Frame: 60-180 minutes ] [ Designated as safety issue: No ]
Time from medication administration to study completion.
Not Provided
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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
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
Both
6 Months to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01255904
H-27453
Yes
Jason Reynolds, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Not Provided
Baylor College of Medicine
January 2015

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