Overview

Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

Status:
Completed

Trial end date:
2011-01-01

Target enrollment:

Participant gender:

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

Phase:

Phase 3

Details

Lead Sponsor:

Hospira, Inc.
Hospira, now a wholly owned subsidiary of Pfizer

Treatments:

Dexmedetomidine
Fentanyl
Midazolam
Morphine