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CompletedNCT00949780Updated Jul 31, 2009

Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

A Phase 2 interventional study of Chloral Hydrate in Auditory Brainstem Response in Children and Sedation With Chloral Hydrate, sponsored by Pontificia Universidade Catolica de Sao Paulo. Completed at 2 sites in Brazil. Open to participants aged 1 Year to 11 Years. Per ClinicalTrials.gov, last updated 2009-07-31.

Sponsored by Pontificia Universidade Catolica de Sao Paulo · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
1 Year to 11 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Auditory Brainstem Response in Children
  • Sedation With Chloral Hydrate

Keywords

  • ABR
  • Chloral Hydrate
  • Sedation
  • Children
03

In context

Lead sponsor

Pontificia Universidade Catolica de Sao Paulo is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe heart or lung disease
05

Study design

Phase
Phase 2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    chloral hydrate , sedative

    Drug: Chloral Hydrate

Interventions

  • DrugChloral Hydrate
06

What researchers measure

Primary outcomes

  1. 36 patients slept

    Time frame: one hour

07

Study locations

2 sites
  • Mariana Lopes Favero
    São Paulo, 01327002, Brazil
  • Derdic-Pucsp
    São Paulo, 05015-001, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00949780
Lead sponsor
Pontificia Universidade Catolica de Sao Paulo
First posted
Jul 30, 2009
Start date
Oct 2007
Primary completion
Mar 2008
Completion
Oct 2008
Last update
Jul 31, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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