NCT00004424

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. Sedative doses may be reduced if necessary. Treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced. Patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.

Conditions

• Respiration Disorders

Interventions

Type	Name	Description
DRUG	fentanyl
DRUG	Midazolam
DRUG	propofol

Timeline

• Start date: 1996-07-01
• Completion: 2000-03-01
• First posted: 1999-10-19
• Last updated: 2015-03-25