A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Moderate Sedation
Intervention: Dexmedetomidine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Baylor College of Medicine
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).
Official title: A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Minimum age: 6 Months.
Maximum age: 8 Years.
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.
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
Locations and Contacts
Texas Childrens Hospital, Houston, Texas 77030, United States; Not yet recruiting
Jason Reynolds, MD, Phone: 832-824-5800, Email: email@example.com
Last updated: December 7, 2010