Trial record 1 of 5 for:    "Brainstem auditory evoked responses"
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Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

This study has been completed.
Sponsor:
Information provided by:
Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00949780
First received: July 28, 2009
Last updated: July 30, 2009
Last verified: July 2009
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mariana Lopes Favero, Pontificia Universidade Catolica de São Paulo
ClinicalTrials.gov Identifier: NCT00949780     History of Changes
Other Study ID Numbers: PUCSP-HC
Study First Received: July 28, 2009
Last Updated: July 30, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014