Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures

Overview

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.

Full Title of Study: “Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 30, 2020

Interventions

  • Drug: Chlorpromazine or Pentobarbital
    • Sedation

Arms, Groups and Cohorts

  • Chlorpromazine
  • Pentobarbital

Clinical Trial Outcome Measures

Primary Measures

  • Sedation success
    • Time Frame: During the procedure
    • Imaging purpose is answered

Secondary Measures

  • Induction time
    • Time Frame: During the procedure
    • Length of time required after the administration to achieve adequate sedation
  • Hospitalization duration
    • Time Frame: Through procedure completion
    • Length of time from planned time of admission to discharge
  • Duration of the imaging procedure
    • Time Frame: During the procedure
    • Length of acquisition time from the first to the last images
  • Secondary effects
    • Time Frame: From Procedure until 2 days after
    • Number of participant developing any secondary effects
  • 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.
  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Children – Sedation for the purpose of imaging – Sedation using chlorpromazine or pentobarbital Exclusion Criteria:

  • Refusal to participate

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Brest
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juliette Ropars, MD, Study Director, Brest University Hospital in France
  • Overall Contact(s)
    • Juliette ROPARS, MD, 02 98 22 33 89, juliette.ropars@chu-brest.fr

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