Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
Primary Purpose
Respiration Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fentanyl
Midazolam
propofol
Sponsored by

About this trial
This is an interventional treatment trial for Respiration Disorders focused on measuring disease-related problem/condition, oncologic disorders, pulmonary complications, rare disease, Respiration, Artificial
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004424
First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
Collaborators
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT00004424
Brief Title
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
FDA Office of Orphan Products Development
Collaborators
Case Western Reserve University
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Disorders
Keywords
disease-related problem/condition, oncologic disorders, pulmonary complications, rare disease, Respiration, Artificial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Type
Drug
Intervention Name(s)
propofol
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Deneal Reed
Organizational Affiliation
Case Western Reserve University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
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