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Impact on delirium of the use of DEXmedetomidine as first-line sedation in PEDIAtric intensive care: the PEDIADEX randomized controlled trial
EU CTIS ID: 2025-521039-35-00
What this study is testing
To assess if continuous intravenous infusion of dexmedetomidine is effective to reduce the prevalence of delirium in critically ill children, needing mechanical ventilation for more than 12 hours.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children between 1 month to 17 years and 6 months
- 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 likely can't join if
- Patients under guardianship, curatorship or legal protection
- Palliative care on admission
- Significant bradycardia (cf table)
- 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
See the full eligibility criteria
- Children between 1 month to 17 years and 6 months
- 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
- Patients under guardianship, curatorship or legal protection
- Palliative care on admission
- Significant bradycardia (cf table)
- 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
- Study interventions contraindications
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.