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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development Case Western Reserve University |
|---|---|
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004424 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiration Disorders |
Drug: fentanyl Drug: Midazolam Drug: propofol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind |
| Estimated Enrollment: | 120 |
| Study Start Date: | July 1996 |
| Estimated Study Completion Date: | March 2000 |
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations More Information
| Study ID Numbers: | 199/13353, CWRU-FDR000852 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004424 History of Changes |
| Health Authority: | United States: Federal Government |
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disease-related problem/condition oncologic disorders pulmonary complications rare disease Respiration, Artificial |
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Anesthetics, Intravenous Neurotransmitter Agents Fentanyl Tranquilizing Agents Respiration Disorders Rare Diseases Adjuvants, Immunologic Psychotropic Drugs Anesthetics Central Nervous System Depressants |
Narcotics Midazolam Respiratory Tract Diseases Anesthetics, General Hypnotics and Sedatives Anti-Anxiety Agents Peripheral Nervous System Agents Analgesics Propofol Analgesics, Opioid |
|
Fentanyl Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Respiratory Tract Diseases Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Propofol Analgesics, Opioid |
Anesthetics, Intravenous Tranquilizing Agents Respiration Disorders Central Nervous System Depressants Narcotics Midazolam Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |
