Overview

Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy

Status:
Completed

Trial end date:
2000-03-01

Target enrollment:

Participant gender:

Summary

OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

Phase:

N/A

Details

Lead Sponsor:

FDA Office of Orphan Products Development

Collaborator:

Case Western Reserve University

Treatments:

Fentanyl
Midazolam
Propofol