Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Status:	Completed
Conditions:	Chronic Pain, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases, Musculoskeletal
Healthy:	No
Age Range:	18 - Any
Updated:	5/27/2013
Start Date:	June 2011
End Date:	April 2013

A Multi-Center, Open-Label, Surveillance Trial To Evaluate The Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen.

The primary objective of this study is to determine the safety of a single dose of
intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in
the hospital setting.

Inclusion Criteria:

- Pain: Patients with baseline VAS assessment >3, -and/or- Fever: Patients with
temperature >101°F.

Exclusion Criteria:

1. Patients with inadequate IV access

2. Patients <18 years of age

3. History or allergy or hypersensitivity to any component of intravenous ibuprofen,
aspirin (or aspirin related products) or NSAIDs

4. Active hemorrhage or clinically significant bleeding

5. Pregnant or nursing

6. Patients in the peri-operative period in the setting of coronary artery bypass graft
(CABG) surgery

7. Inability to understand the requirements of the study, be willing to provide written
informed consent (as evidenced by signature on an informed consent document approved
by an Institutional Review Board [IRB]), and agree to abide by the study restrictions

8. Refusal to provide written authorization for use and disclosure of protected health
information

We found this trial at

sites

Lankenau

Wynnewood, Pennsylvania 19096

from

Wynnewood, PA