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Chloral Hydrate to Perform Auditory Brainstem Response (ABR)

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00949780
Enrollment
41
Registered
2009-07-30
Start date
2007-10-31
Completion date
2008-10-31
Last updated
2009-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Brainstem Response in Children, Sedation With Chloral Hydrate

Keywords

ABR, Chloral Hydrate, Sedation, Children

Brief 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.

Interventions

Sponsors

Pontificia Universidade Catolica de Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* severe heart or lung disease

Design outcomes

Primary

MeasureTime frame
36 patients sleptone hour

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026