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

NCT00004424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Respiration Disorders

Interventions

DRUG

fentanyl

DRUG

Midazolam

DRUG

propofol

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Michael Deneal Reed · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-07-31
Completion
2000-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004424 on ClinicalTrials.gov