Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004424
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Assess the degree of amnesia afforded by study sedatives relative to the patients 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
I Assess the degree of amnesia afforded by study sedatives relative to the patients 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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CWRU-FDR000852 | None | None | None |