- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949780
Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
Use of 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil, 01327002
- Mariana Lopes Favero
-
São Paulo, Brazil, 05015-001
- Derdic-Pucsp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- no success in previous attempts to perform the test during natural sleep
Exclusion Criteria:
- severe heart or lung disease
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: chloral hydrate , sedative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
36 patients slept
Time Frame: one hour
|
one hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUCSP-HC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Auditory Brainstem Response in Children
-
Children's Hospital Medical Center, CincinnatiCompletedAuditory Brainstem ResponseUnited States
-
Fondation LenvalCompleted
-
Queen Fabiola Children's University HospitalBelgium Kid's FundRecruitingSex Differences in Immune Response | Acute Inflammatory Diseases in ChildrenBelgium
-
CHU de ReimsCompletedBrainstem ResponseFrance
-
The University of Texas Health Science Center,...WithdrawnHospitalism in ChildrenUnited States
-
Universitair Ziekenhuis BrusselCompletedHospitalization in ChildrenBelgium
-
Hacettepe UniversityCompleted
-
University Children's HospitalCompletedPropofol Anesthesia in ChildrenSerbia
-
University of British ColumbiaCompletedThreonine Requirements in ChildrenCanada
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedFiberoptic Intubation in ChildrenUnited States
Clinical Trials on Chloral Hydrate
-
Sun Yat-sen UniversityCompletedCongenital Cataract
-
University of FloridaNational Institutes of Health (NIH)Completed
-
Yonsei UniversityCompleted
-
PharmanoviaRecruitingInsomnia | Insomnia Chronic | Chloral HydrateUnited Kingdom
-
Wesley Medical CenterHospira, now a wholly owned subsidiary of PfizerWithdrawnProcedural SedationUnited States
-
Federal University of Minas GeraisSanta Casa de Misericórdia de Belo HorizonteCompletedOther Conditions of BrainBrazil
-
Guangzhou Women and Children's Medical CenterCompletedFailed Moderate Sedation During Procedure | Administration Related Reaction | Chloral Hydrate Adverse ReactionChina
-
Seoul National University HospitalRecruiting
-
University of Cape TownCompletedEpilepsy | Children | Sedation | ElectroencephalogramSouth Africa
-
Seoul National University HospitalNot yet recruiting