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

Respiration Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004424
• Other study ID #: 199/13353
• Secondary ID: CWRU-FDR000852
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: July 1996
• Est. completion date: March 2000

Study information

• Verified date: April 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiration Disorders

Intervention

Drug:
• fentanyl

• Midazolam

• propofol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development	Case Western Reserve University