Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care (NCT07542990) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
France266 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range1 Month – 18 Years
SexALL
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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…
What they're measuring
1
Proportion of children with at least one episode of delirium during the ICU stay.
Timeframe: From enrollment to the end of ICU stay, up to 90 days