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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.
Case Western Reserve University
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: April 2000


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.


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
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Please refer to this study by its identifier: 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 Identifier: NCT00004424     History of Changes
Other Study ID Numbers: 199/13353
Study First Received: October 18, 1999
Last Updated: March 24, 2015

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 processed this record on August 18, 2017