Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures (PREIMAPED)

April 16, 2020 updated by: University Hospital, Brest

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing sedation for the purpose of imaging in the pediatric department of Brest hospital

Description

Inclusion Criteria:

  • Children
  • Sedation for the purpose of imaging
  • Sedation using chlorpromazine or pentobarbital

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chlorpromazine
Drug: Chlorpromazine or Pentobarbital
Sedation
Pentobarbital
Drug: Chlorpromazine or Pentobarbital
Sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation success
Time Frame: During the procedure
Imaging purpose is answered
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction time
Time Frame: During the procedure
Length of time required after the administration to achieve adequate sedation
During the procedure
Hospitalization duration
Time Frame: Through procedure completion
Length of time from planned time of admission to discharge
Through procedure completion
Duration of the imaging procedure
Time Frame: During the procedure
Length of acquisition time from the first to the last images
During the procedure
Secondary effects
Time Frame: From Procedure until 2 days after
Number of participant developing any secondary effects
From Procedure until 2 days after
Failure of pentobarbital sedation in children older than 5 years
Time Frame: During the procedure
Comparison of the rate of failure of pentobarbital sedation in children older than 5 years compared to those younger.
During the procedure
Failure of pentobarbital sedation in children with a behavioral disorder
Time Frame: During the procedure
Comparison of the rate of failure of pentobarbital sedation in children with a behavioral disorder compared to those without
During the procedure
Failure of pentobarbital sedation in children under chronic antiepileptic treatment
Time Frame: During the procedure
Comparison of the rate of failure of pentobarbital sedation in children under chronic antiepileptic treatment compared to those without
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Juliette Ropars, MD, Brest University Hospital in France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 30, 2020

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (ACTUAL)

April 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREIMAPED (29BRC19.0309)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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