NCT00949780

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 mg/kg. Objective: To assess the efficacy of CH as a sedative agent in performing ABR in children and to systematize its use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

July 28, 2009

Last Update Submit

July 30, 2009

Conditions

Auditory Brainstem Response in ChildrenSedation With Chloral Hydrate

Keywords

ABRChloral HydrateSedationChildren

Outcome Measures

Primary Outcomes (1)

  • 36 patients slept

    one hour

Study Arms (1)

chloral hydrate , sedative

ACTIVE COMPARATOR
Drug: Chloral Hydrate

Interventions

Chloral HydrateDRUG
chloral hydrate , sedative

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • no success in previous attempts to perform the test during natural sleep

You may not qualify if:

  • severe heart or lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mariana Lopes Favero

São Paulo, São Paulo, 01327002, Brazil

Location

Derdic-Pucsp

São Paulo, São Paulo, 05015-001, Brazil

Location

MeSH Terms

Interventions

Chloral Hydrate

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 30, 2009

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

October 1, 2008

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

BR(2)