At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Double-blind, Dose-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Dexmedetomidine in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit Subjects
In Brief
A Phase 3 clinical trial evaluating Dexmedetomidine, Midazolam, and 2 other interventions for Sedation. Completed, enrolled 175 participants across 37 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are: * To characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects * To evaluate the safety and efficacy of loading and maintenance infusions for sedation in initially intubated and mechanically ventilated PICU subjects * To explore the exposure-response relationship between dose of DEX and clinical measures of sedation and safety
Study Details
Timeline
Interventions
Study drug titrated up or down to maintain target UMSS range.
Rescue medication for sedation according to UMSS scores
Rescue medication for pain based on UMSS scores
Rescue medication for pain based on UMSS scores.