Dexmedetomidine for Delirium

Inclusion criteria

• {"criterion_text":"- Children between 1 month to 17 years and 6 months\n- Participants covered by or entitled to French social security\n- 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)\n- Ability for participant to comply with the requirements of the study\n- Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- The proportion of children with at least one episode of delirium during the pediatric intensive care stay, measured with CAPD scale. Delirium will be defined as CAPD higher or equal to 9.","definition_or_measurement_approach":"Measured with the CAPD (Cornell Assessment of Pediatric Delirium) scale. Delirium defined as CAPD score >= 9."}

Secondary endpoints

• {"endpoint_text":"- The percentage of sedation scores in the target sedation range evaluated with COMFORT B scale every 4 hours, in each group","definition_or_measurement_approach":"Evaluated with COMFORT B scale every 4 hours; percentage of scores within target range."}
• {"endpoint_text":"- Percentage of under-sedation, and adverse events (such as unplanned extubation with reintubation, accidental removal of a central line)","definition_or_measurement_approach":"Percentage of under-sedation and monitoring/reporting of adverse events including unplanned extubation with reintubation and accidental central line removal."}
• {"endpoint_text":"- Percentage of over-sedation","definition_or_measurement_approach":"Percentage of over-sedation as assessed by sedation scoring (e.g., COMFORT B)."}
• {"endpoint_text":"- The daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group.","definition_or_measurement_approach":"Daily cumulative weight-adjusted dose (per kg) of IV sedatives and opioids recorded for each group."}
• {"endpoint_text":"- Number of days exposed to sedatives and opioids","definition_or_measurement_approach":"Count of days of exposure to sedatives and opioids per participant."}
• {"endpoint_text":"- The incidence of iatrogenic withdrawal syndrome","definition_or_measurement_approach":"Incidence measured by standardized withdrawal assessment (WAT score referenced elsewhere); reported as incidence proportion."}
• {"endpoint_text":"- The number of days with CAPD score higher than or equal to 9","definition_or_measurement_approach":"Count of days with CAPD >= 9 per participant."}
• {"endpoint_text":"- The severity of delirium defined by the need for antipsychotic drugs","definition_or_measurement_approach":"Severity proxied by requirement for antipsychotic medication during PICU stay."}
• {"endpoint_text":"- Hypotension/ bradycardia, needing an intervention, unplanned extubation","definition_or_measurement_approach":"Recording of haemodynamic events (hypotension/bradycardia) requiring intervention and occurrences of unplanned extubation."}
• {"endpoint_text":"- accidental removal of a central line","definition_or_measurement_approach":"Record of accidental central line removals during PICU stay."}
• {"endpoint_text":"- The mechanical ventilation time in hours","definition_or_measurement_approach":"Total hours of invasive mechanical ventilation per participant."}
• {"endpoint_text":"- Need for re-intubation post extubation","definition_or_measurement_approach":"Occurrence of re-intubation after extubation recorded."}
• {"endpoint_text":"- Percentage of brain imaging , electroencephalogramm","definition_or_measurement_approach":"Percentage of participants undergoing brain imaging and EEG."}
• {"endpoint_text":"- Intensive care unit length of stay, in days","definition_or_measurement_approach":"Length of stay in ICU measured in days."}
• {"endpoint_text":"- Hospital length of stay out of the intensive care unit, in days","definition_or_measurement_approach":"Days of hospitalisation outside ICU measured in days."}
• {"endpoint_text":"- In-hospital mortality","definition_or_measurement_approach":"Mortality occurring during the hospital admission (in-hospital)."}
• {"endpoint_text":"- The incidence of iatrogenic withdrawal syndrome","definition_or_measurement_approach":"Incidence measured and reported (duplicate/also listed as endpoint 6)."}
• {"endpoint_text":"- Difference in the costs of sedative, analgesics and opioids consumed during the paediatric intensive care stay and valued from the hospital perspective;","definition_or_measurement_approach":"Cost difference analysis from hospital perspective for consumptions of sedatives, analgesics and opioids during PICU stay."}
• {"endpoint_text":"- Difference in the cost of inpatient stays and the cost of stays in intensive care units valued from the healthcare system perspective, over a three month time horizon.","definition_or_measurement_approach":"Health-economic analysis comparing inpatient and ICU stay costs from healthcare system perspective over a 3-month horizon."}

Methods

• Eligible patients' legal representative(s) will be approached within 24 hours of initiation of sedation and invasive ventilation at participating PICUs in France. If legal representative(s) are not present or contactable, an emergency inclusion (deferred consent) procedure may be used with information and consent obtained subsequently. Participants must be covered by or entitled to French social security (country-specific eligibility).

France

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

44

Number Of Sites

7

Number Of Participants

266

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France