A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

Baylor College of Medicine90 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sedation

Interventions

Chloral HydrateDRUG

Oral chloral hydrate 50 mg/kg

DexmedetomidineDRUG

Intranasal dexmedetomidine 3 mcg/kg

Oral placeboOTHER

Oral saline administered

Intranasal placebo

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Texas Childrens Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Time to Complete Study

Time from medication administration to study completion.

Time frame: 60-180 minutes

Data from ClinicalTrials.gov

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