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Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949780
First Posted: July 30, 2009
Last Update Posted: July 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pontificia Universidade Catolica de Sao Paulo
  Purpose

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.


Condition Intervention Phase
Auditory Brainstem Response in Children Sedation With Chloral Hydrate Drug: Chloral Hydrate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

Resource links provided by NLM:


Further study details as provided by Pontificia Universidade Catolica de Sao Paulo:

Primary Outcome Measures:
  • 36 patients slept [ Time Frame: one hour ]

Enrollment: 41
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chloral hydrate , sedative Drug: Chloral Hydrate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe heart or lung disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949780


Locations
Brazil
Mariana Lopes Favero
São Paulo, Brazil, 01327002
Derdic-Pucsp
São Paulo, Brazil, 05015-001
Sponsors and Collaborators
Pontificia Universidade Catolica de Sao Paulo
  More Information

Responsible Party: Mariana Lopes Favero, Pontificia Universidade Catolica de São Paulo
ClinicalTrials.gov Identifier: NCT00949780     History of Changes
Other Study ID Numbers: PUCSP-HC
First Submitted: July 28, 2009
First Posted: July 30, 2009
Last Update Posted: July 31, 2009
Last Verified: July 2009

Keywords provided by Pontificia Universidade Catolica de Sao Paulo:
ABR
Chloral Hydrate
Sedation
Children

Additional relevant MeSH terms:
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs