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
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.
Pontificia Universidade Catolica de Sao Paulo is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Chloral Hydrate
36 patients slept
Time frame: one hour
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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Pontificia Universidade Catolica de Sao Paulo