Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures

• Conditions: Children Sedation
• Interventions: Drug: Chlorpromazine or Pentobarbital

• Registration Number: NCT04350528
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-17
• Study Start: 2020-04-30
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

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

Exclusion Criteria

• Refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chlorpromazine	Chlorpromazine or Pentobarbital	-
Pentobarbital	Chlorpromazine or Pentobarbital	-

Primary Outcome Measures

Name	Time	Method
Sedation success	During the procedure	Imaging purpose is answered

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France