Auditory Brainstem Response in ChildrenPhase 2NCT00949780
Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
A Phase 2 study testing Chloral Hydrate in people with Auditory Brainstem Response in Children and Sedation With Chloral Hydrate, run by Pontificia Universidade Catolica de Sao Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Auditory Brainstem Response in Children, Sedation With Chloral Hydrate
- What is being tested?
- Chloral Hydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- no success in previous attempts to perform the test during natural sleep
Who cannot join
- severe heart or lung disease
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Mariana Lopes Favero
São Paulo, São Paulo, 01327002
Derdic-Pucsp
São Paulo, São Paulo, 05015-001
About this study
Official title: 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.
Read more
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.
- Being tested
- Chloral Hydrate
- Keywords
- ABR, Chloral Hydrate, Sedation, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloral HydrateDrug
| Study group | Role | What they receive |
|---|---|---|
| chloral hydrate , sedative | Active comparator | Not described Receives: Drug: Chloral Hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
36 patients slept
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Brainstem Response in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Catolica de Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949780
- Sponsor's protocol ID
- PUCSP-HC
- Status last verified
- Jul 2009
- First submitted
- 28 Jul 2009
- Last updated
- 31 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
- ClinicalTrials.gov ID
- NCT00949780
- Acronym / sponsor ID
- PUCSP-HC
- Keywords
- ABR, Chloral Hydrate, Sedation, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pontificia Universidade Catolica de Sao PauloUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chloral hydrate , sedative | Active comparator | Drug: Chloral Hydrate |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- no success in previous attempts to perform the test during natural sleep
Key exclusion criteria (1 listed)
- severe heart or lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloral Hydrate | Drug | chloral hydrate , sedative |
Primary outcome
36 patients slept
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chloral Hydrate in people with Auditory Brainstem Response in Children and Sedation With Chloral Hydrate, run by Pontificia Universidade Catolica de Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
36 patients slept (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2009.