Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures

Study Overview
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Brief Summary
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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.

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

Conditions
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Children Sedation

Intervention / Treatment
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* Drug: Chlorpromazine or Pentobarbital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Sedation for the purpose of imaging Sedation using chlorpromazine or pentobarbital Exclusion Criteria: Refusal to participate

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chlorpromazine<br> | Drug: Chlorpromazine or Pentobarbital<br>* Sedation<br>|
| Pentobarbital<br> | Drug: Chlorpromazine or Pentobarbital<br>* Sedation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction time | Length of time required after the administration to achieve adequate sedation | During the procedure | 
| Hospitalization duration | Length of time from planned time of admission to discharge | Through procedure completion | 
| Duration of the imaging procedure | Length of acquisition time from the first to the last images | During the procedure | 
| Secondary effects | Number of participant developing any secondary effects | 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. | 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 | 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 | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Medical imaging, Children, Pentobarbital, Chlorpromazine, Efficacy, Safety