Phase 4
Completed N=90
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Sedation
Source: ClinicalTrials.gov NCT01255904 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Time to Complete Study — 85.5; 110 Minutes
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Complete Study |
85.5; 110 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01255904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.