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.
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)
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
Parallel
Dexmedetomidine
DrugParticipants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm
Midazolam
Drugparticipant will receive midazolam as the comparator group
Proportion of children with at least one episode of delirium during the ICU stay.
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.
Sedation efficacy
Investigators will assess: * The percentage of sedation scores in the target sedation range evaluated with COMFORT B scale every 4 hours, in each group * Percentage of under-sedation, and adverse events (such as unplanned extubation with reintubation, accidental removal of a central line) * Percentage of over-sedation
Duration of delirium
Investigators will assess the number of days with CAPD score higher than or equal to 9
Adverse events and serious adverse events
Investigators will record: * Hypotension and/or bradycardia needing an intervention, unplanned extubation * accidental removal of a central line
Mechanical ventilation
Investigators will report the mechanical ventilation time in hours
Click on the lead sponsor to view all of their trials.
University Hospital, Tours
Lead sponsor
University Hospital, Angers
Collaborator
University Hospital, Lille
Collaborator
Nantes University Hospital
Collaborator
University Hospital, Strasbourg, France
Collaborator
University Hospital, Marseille
Collaborator
University Hospital, Caen
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
