Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
|ClinicalTrials.gov Identifier: NCT00949780|
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : July 31, 2009
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.
To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use.
|Condition or disease||Intervention/treatment||Phase|
|Auditory Brainstem Response in Children Sedation With Chloral Hydrate||Drug: Chloral Hydrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||October 2008|
|Active Comparator: chloral hydrate , sedative||
Drug: Chloral Hydrate
- 36 patients slept [ Time Frame: one hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949780
|Mariana Lopes Favero|
|São Paulo, Brazil, 01327002|
|São Paulo, Brazil, 05015-001|