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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004424
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Case Western Reserve University
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 1996
Study Completion Date : March 2000

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Patients admitted to the Rainbow Babies and Children's Hospital Pediatric Intensive Care Unit who require mechanical ventilation and sedation therapy
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004424

Sponsors and Collaborators
FDA Office of Orphan Products Development
Case Western Reserve University
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Study Chair: Michael Deneal Reed Case Western Reserve University
Layout table for additonal information Identifier: NCT00004424    
Other Study ID Numbers: 199/13353
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: April 2000
Keywords provided by FDA Office of Orphan Products Development:
disease-related problem/condition
oncologic disorders
pulmonary complications
rare disease
Respiration, Artificial
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action