Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
NCT ID: NCT00004424
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
1996-07-31
2000-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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fentanyl
Midazolam
propofol
Eligibility Criteria
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Inclusion Criteria
* Mean COMFORT score must be greater than 26 after 3 consecutive scores are obtained at 2 minute intervals over 6 minutes
* No other concurrent sedative therapy
18 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
FDA Office of Orphan Products Development
FED
Principal Investigators
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Michael Deneal Reed
Role: STUDY_CHAIR
Case Western Reserve University
Other Identifiers
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CWRU-FDR000852
Identifier Type: -
Identifier Source: secondary_id
199/13353
Identifier Type: -
Identifier Source: org_study_id
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