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

Name: Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care — clinical trial record (NCT07542990)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: PEDIADEX

StatusNot Yet Recruiting

PhasePhase 3

SponsorUniversity Hospital, Tours

Started2026-11-15

View on ClinicalTrials.gov ↗

University Hospital, Tours

120 trials monitored

See 2 trials at risk

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.

Trial Details

NCT Number	NCT07542990
Lead Sponsor	University Hospital, Tours Collaborators: University Hospital, Angers, University Hospital, Lille, Nantes University Hospital, University Hospital, Strasbourg, France, University Hospital, Marseille, University Hospital, Caen
Conditions	Delirium in the Intensive Care Unit
Enrollment	266 participants
Start Date	2026-11-15
Primary Completion	2029-04-15 (estimated)
Study Completion	2029-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-09-28