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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521039-35-00
Acronym
PEDIADEX
Enrollment
266
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impact on delirium of the use of DEXmedetomidine as first-line sedation in PEDIAtric intensive care:

Brief summary

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.

Detailed description

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, The daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group., Number of days exposed to sedatives and opioids, The incidence of iatrogenic withdrawal syndrome, The number of days with CAPD score higher than or equal to 9, The severity of delirium defined by the need for antipsychotic drugs, Hypotension/ bradycardia, needing an intervention, unplanned extubation, accidental removal of a central line, The mechanical ventilation time in hours, Need for re-intubation post extubation, Percentage of brain imaging , electroencephalogramm, Intensive care unit length of stay, in days, Hospital length of stay out of the intensive care unit, in days, In-hospital mortality, The incidence of iatrogenic withdrawal syndrome, Difference in the costs of sedative, analgesics and opioids consumed during the paediatric intensive care stay and valued from the hospital perspective;, 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.

Interventions

DRUGMidazolam Lek 1 mg/ml raztopina za injiciranje/infundiranje

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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, The daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group., Number of days exposed to sedatives and opioids, The incidence of iatrogenic withdrawal syndrome, The number of days with CAPD score higher than or equal to 9, The severity of delirium defined by the need for antipsychotic drugs, Hypotension/ bradycardia, needing an intervention, unplanned extubation, accidental removal of a central line, The mechanical ventilation time in hours, Need for re-intubation post extubation, Percentage of brain imaging , electroencephalogramm, Intensive care unit length of stay, in days, Hospital length of stay out of the intensive care u

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026