Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Condition(s) studied
Investigational drug(s) / intervention(s)
Dexmedetomidine: Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm
Midazolam: participant will receive midazolam as the comparator group
Study summary
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is :
• Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ? Researchers will compare dexmetomidine to midazolam, to see if the use of dexmedetomidine reduces the prevalence of delirium.
Participants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.
Eligibility
Primary outcome measure(s)
- Proportion of children with at least one episode of delirium during the ICU stay. — From enrollment to the end of ICU stay, up to 90 days
Surveillance of delirium is part of the routine neurological monitoring in pediatric ICU. CAPD score is an 8-items scale. A score of 9 points or higher indicates the presence of delirium. We will evaluate the proportion of children with at least one CAPD score higher than 9.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU d'Angers | Angers | France | |
| CHU de Caen | Caen | France | |
| CHU de Lille | Lille | France | |
| CHU de Marseille | Marseille | France | |
| CHU de Nantes | Nantes | France | |
| CHU de Strasbourg | Strasbourg | France | |
| CHU de Tours | Tours | France |
More University Hospital, Tours trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07542990 on ClinicalTrials.gov ↗ ← All trials in France