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

Starting soon · Phase 3

Conditions studied: Delirium in the Intensive Care Unit

In brief

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.

Key facts

Study ID

NCT07542990

Run by

University Hospital, Tours

People needed

266

Starts

2026-04-15

Expected to finish

2029-08-15

Last updated by the study team

2026-04-21

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children between 1month to 17 years and 6 months
• Sedation and analgesia for mechanical ventilation for more than 12 hours
• Participants covered by or entitled to French social security
• Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and/or able to consent, informed consent from the participant's legal representative(s)
• Ability for participant to comply with the requirements of the study
• Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion

You may not qualify if…

• Patients under guardianship, curatorship or legal protection
• Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)
• High-grade heart conduction disorder (Second or third-degree atrioventricular block)
• Status epilepticus
• Intracranial hypertension
• Sedation for more than 6 hours by benzodiazepines at the time of inclusion
• Need for paralytic medication (neuromuscular blocker) at admission to PICU
• Following cardiac surgery
• Palliative care on admission
• Significant bradycardia
• Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine
• Patient already enrolled in the study previously
• Expected duration of invasive mechanical ventilation inferior to 12 hours
• Hospitalized in a pediatric intensive care unit without computerized prescription software

Where it is running

• 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

Full record on ClinicalTrials.gov

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