NCT Number: NCT00949780
Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
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.
Looking for future studies?
Notify MeKey information
Age range
1 year–11 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Derdic-Pucsp, São Paulo, Brazil
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- no success in previous attempts to perform the test during natural sleep
Exclusion criteria
- severe heart or lung disease
Treatment and study plan
Primary outcomes
-
36 patients slept
Time frame: one hour
Sponsors and collaborators
Lead sponsor
Pontificia Universidade Catolica de Sao Paulo
Other
Registry information
Official study title
Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
Important dates
- Study start
- 2007
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jul 30, 2009
- Registry last updated
- Jul 31, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.