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Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

NCT ID: NCT00949780

Last Updated: 2009-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Auditory Brainstem Response in Children Sedation With Chloral Hydrate

Keywords

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ABR Chloral Hydrate Sedation Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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chloral hydrate , sedative

Group Type ACTIVE_COMPARATOR

Chloral Hydrate

Intervention Type DRUG

Interventions

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Chloral Hydrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* severe heart or lung disease
Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidade Catolica de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Pontificia Universidade Catolica de São Paulo

Locations

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Mariana Lopes Favero

São Paulo, São Paulo, Brazil

Site Status

Derdic-Pucsp

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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PUCSP-HC

Identifier Type: -

Identifier Source: org_study_id