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NOT YET RECRUITING
NCT07542990
PHASE3

Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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

Interventions

DRUG

Dexmedetomidine

Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm

DRUG

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