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OpenTrials
Completed

NCT Number: NCT00949780

Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in pediatric and dental procedures owing to the low depressive effect it has over respiratory and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and sudden death in children, especially when using high doses, probably due to accumulation of serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the drug. A possible carcinogenic action observed in guinea pigs has also been reported, even though it has not been confirmed in human beings.

Among the least severe complications there are paradoxical agitation, nausea, vomiting and excessive sleepiness.

CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test (ABR), in which any movement or muscle contraction may generate artifacts that interfere in the analysis.

Profound sleep that lasts on average one hour is rapidly induced depending on the used dose, causing no residual sleepiness after this period; however, there is consensus in the literature about the best dose, which may range from 40 to 100 mg/kg.

Objective:

To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use.

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Key information

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Derdic-Pucsp, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • no success in previous attempts to perform the test during natural sleep

Exclusion criteria

  • severe heart or lung disease

Treatment and study plan

Chloral Hydrate

Drug

Primary outcomes

  1. 36 patients slept

    Time frame: one hour

Sponsors and collaborators

Lead sponsor

Pontificia Universidade Catolica de Sao Paulo

Other

Registry information

Official study title

Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 30, 2009
Registry last updated
Jul 31, 2009

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.