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Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Sponsor: University Hospital, Tours
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.
Official title: Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care: the PEDIADEX Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2026-04-15
Completion Date
2029-08-15
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
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
Locations (7)
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