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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
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.
Case Western Reserve University
Information provided by:
FDA Office of Orphan Products Development


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: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 120
Study Start Date: July 1996
Estimated Study Completion Date: March 2000
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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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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00004424

Sponsors and Collaborators
FDA Office of Orphan Products Development
Case Western Reserve University
Study Chair: Michael Deneal Reed Case Western Reserve University
  More Information

ClinicalTrials.gov Identifier: NCT00004424     History of Changes
Other Study ID Numbers: 199/13353
First Submitted: October 18, 1999
First Posted: October 19, 1999
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:
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