Ignite Creation Date:
2024-05-05 @ 9:41 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00949780
Status:
COMPLETED
Last Update Posted:
2009-07-31
First Post:
2009-07-28
Brief Title:
Chloral Hydrate to Perform Auditory Brainstem Response ABR
Sponsor:
Pontificia Universidade Catolica de Sao Paulo
Organization:
Pontificia Universidade Catolica de Sao Paulo
Study Overview
Official Title:
Use of Chloral Hydrate to Perform Auditory Brainstem Response ABR
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg
Objective
To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use
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 mgkg
Objective
To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None