drugset / Trial / NCT00004424
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
Completed
120 enrolled
FDA Office of Orphan Products Development
Case Western Reserve University · collab
RandomizedDouble-blindTreatment
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.
Timeline
- Start
- 1996-07
- Primary completion
- —
- Completion
- 2000-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fentanyl | Other / unclassified | — | — |
| Subject | Midazolam | Small molecule | — | — |
| Subject | Propofol | Small molecule | — | — |