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Starting soon Phase 3

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

NCT07542990 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-11-15
Last updated
2026-09-28

Condition(s) studied

Delirium in the Intensive Care Unit

Investigational drug(s) / intervention(s)

Dexmedetomidine →Midazolam →

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

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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)

FacilityCityRegionStatus
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
Official registry record

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