Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures

Children Sedation Clinical Trial

— PREIMAPED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04350528
• Other study ID #: PREIMAPED (29BRC19.0309)
• Status: Not yet recruiting
• Start date: April 30, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Brest
• Contact: Juliette ROPARS, MD
• Phone: 02 98 22 33 89
• Email: juliette.ropars[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 254
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Children

• Sedation for the purpose of imaging

• Sedation using chlorpromazine or pentobarbital

Exclusion Criteria:

• Refusal to participate

Related Conditions & MeSH terms

• Children Sedation

Intervention

Drug:
• Chlorpromazine or Pentobarbital
Sedation

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation success	Imaging purpose is answered	During the procedure
Secondary	Induction time	Length of time required after the administration to achieve adequate sedation	During the procedure
Secondary	Hospitalization duration	Length of time from planned time of admission to discharge	Through procedure completion
Secondary	Duration of the imaging procedure	Length of acquisition time from the first to the last images	During the procedure
Secondary	Secondary effects	Number of participant developing any secondary effects	From Procedure until 2 days after
Secondary	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.	During the procedure
Secondary	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	During the procedure
Secondary	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	During the procedure