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

Baylor College of Medicine

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Other: Intranasal placebo; Drug: Chloral Hydrate; Other: Oral placebo; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01255904

H-27453

Details and patient eligibility

About

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).

Enrollment: 90 patients

Sex: All

Ages: 6 months to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Arm 1

Experimental group

Description:

Oral Chloral and intranasal placebo

Treatment:

Drug: Chloral Hydrate

Other: Intranasal placebo

Arm 2

Experimental group

Description:

oral placebo and intranasal dexmedetomidine

Treatment:

Other: Oral placebo

Drug: Dexmedetomidine