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OpenTrials
Completed

NCT Number: NCT01255904

A 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).

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Key information

Conditions

Sedation

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Texas Childrens Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloral Hydrate

Drug

Oral chloral hydrate 50 mg/kg

Dexmedetomidine

Drug

Intranasal dexmedetomidine 3 mcg/kg

Oral Placebo

Other

Oral saline administered

Intranasal Placebo

Other

Intranasal saline administered

Primary outcomes

  1. Time to Complete Study

    Time frame: 60-180 minutes

    Time from medication administration to study completion.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 8, 2010
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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