Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
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|ClinicalTrials.gov Identifier: NCT00004424|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiration Disorders||Drug: fentanyl Drug: Midazolam Drug: propofol||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Study Start Date :||July 1996|
|Study Completion Date :||March 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004424
|Study Chair:||Michael Deneal Reed||Case Western Reserve University|