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 range
1 Month – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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