Phase 3 DEXmedetomidine vs Midazolam for Delirium in Critically Ill Children
Summary
NIH has registered a Phase 3 clinical trial (NCT07542990) evaluating dexmedetomidine as first-line sedation in critically ill children requiring mechanical ventilation for more than 12 hours. The trial will compare dexmedetomidine against midazolam, measuring whether it reduces the proportion of children experiencing at least one delirium episode during their ICU stay. Participants are randomized to receive sedation per study protocol.
“Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ?”
What changed
NIH has registered a new Phase 3 clinical trial (NCT07542990) titled 'Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care.' The trial will enroll pediatric patients requiring mechanical ventilation exceeding 12 hours and randomize participants to receive either dexmedetomidine or midazolam, with delirium incidence during ICU stay as the primary endpoint.
Healthcare providers and clinical investigators involved in pediatric critical care should be aware of this trial as it may inform future sedation protocols. Sites considering participation should review the ClinicalTrials.gov record for investigator requirements, enrollment criteria, and study locations.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Phase 3 NCT07542990 Kind: PHASE3 Apr 21, 2026
Abstract
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.
Conditions: Delirium in the Intensive Care Unit
Interventions: Dexmedetomidine, Midazolam
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