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Not yet recruitingPhase 3

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

Key facts

Who runs it
University Hospital, Tours
Where
France7 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 3
People taking part
266 people, planned
Started
15 Nov 2026
Expected to end
15 Aug 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Dexmedetomidine
  • Midazolam
Record updated
28 September 2026

Who can take part

Age
1 month to 18 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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 :

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• 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.

The 2 groups in the trial

  • dexmedetomidineTreatment being tested

    Participants with invasive ventilation will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours.

  • midazolamExisting treatment, for comparison

    In the control group, participants will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care: the PEDIADEX Randomized Controlled Trial
Record updated
28 September 2026