Children SedationPREIMAPEDNCT04350528
Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures
An observational study of Children Sedation, run by University Hospital, Brest at 1 site in France.
Trial summary
Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Children Sedation
- What is being tested?
- Chlorpromazine or Pentobarbital
- How many people
- 254 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to 30 Jun 2020
- Phase
- Observational
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing sedation for the purpose of imaging in the pediatric department of Brest hospital
Who may be able to join
- Children
- Sedation for the purpose of imaging
- Sedation using chlorpromazine or pentobarbital
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Brest
Brest, 29609
Juliette ROPARS, juliette.ropars@chu-brest.fr
About this study
Official title: Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study
Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.
- Conditions
- Children Sedation
- Being tested
- Chlorpromazine or Pentobarbital
- Keywords
- Sedation, Medical imaging, Children, Pentobarbital, Chlorpromazine, Efficacy, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorpromazine or PentobarbitalDrug
Sedation
| Study group | Role | What they receive |
|---|---|---|
| Chlorpromazine | Not described Receives: Drug: Chlorpromazine or Pentobarbital | |
| Pentobarbital | Not described Receives: Drug: Chlorpromazine or Pentobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation success
Imaging purpose is answered
Measured: During the procedure
Secondary outcomes (7)
Induction time
Length of time required after the administration to achieve adequate sedation
Measured: During the procedure
Hospitalization duration
Length of time from planned time of admission to discharge
Measured: Through procedure completion
Duration of the imaging procedure
Length of acquisition time from the first to the last images
Measured: During the procedure
Secondary effects
Number of participant developing any secondary effects
Measured: From Procedure until 2 days after
Failure of pentobarbital sedation in children older than 5 years
Comparison of the rate of failure of pentobarbital sedation in children older than 5 years compared to those younger.
Measured: During the procedure
Failure of pentobarbital sedation in children with a behavioral disorder
Comparison of the rate of failure of pentobarbital sedation in children with a behavioral disorder compared to those without
Measured: During the procedure
Failure of pentobarbital sedation in children under chronic antiepileptic treatment
Comparison of the rate of failure of pentobarbital sedation in children under chronic antiepileptic treatment compared to those without
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children SedationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Ropars, MD, Study director, Brest University Hospital in France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350528
- Sponsor's protocol ID
- PREIMAPED (29BRC19.0309)
- Acronym
- PREIMAPED
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study
- ClinicalTrials.gov ID
- NCT04350528
- Acronym / sponsor ID
- PREIMAPED / PREIMAPED (29BRC19.0309)
- Conditions
- Children Sedation
- Keywords
- Sedation, Medical imaging, Children, Pentobarbital, Chlorpromazine, Efficacy, Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 Apr 2020 (actual)
- 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.
Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorpromazine | – | Drug: Chlorpromazine or Pentobarbital |
| Pentobarbital | – | Drug: Chlorpromazine or Pentobarbital |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing sedation for the purpose of imaging in the pediatric department of Brest hospital
Key inclusion criteria (3 listed)
- Children
- Sedation for the purpose of imaging
- Sedation using chlorpromazine or pentobarbital
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Chlorpromazine or PentobarbitalSedation | Drug | Chlorpromazine, Pentobarbital |
Primary outcome
Sedation success
Time frame: During the procedure
Imaging purpose is answered
7 secondary outcomes
Induction time
Time frame: During the procedure
Hospitalization duration
Time frame: Through procedure completion
Duration of the imaging procedure
Time frame: During the procedure
Secondary effects
Time frame: From Procedure until 2 days after
Failure of pentobarbital sedation in children older than 5 years
Time frame: During the procedure
Failure of pentobarbital sedation in children with a behavioral disorder
Time frame: During the procedure
Failure of pentobarbital sedation in children under chronic antiepileptic treatment
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Juliette Ropars, MD study director
Brest University Hospital in France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Sedation, run by University Hospital, Brest at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliette ROPARS, MD (02 98 22 33 89 ext. +33, juliette.ropars@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation success (time frame: During the procedure). 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 17 Apr 2020.