Overview

Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
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 preemptive treatment of postoperative pain.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cumberland Pharmaceuticals
Treatments:
Ibuprofen
Criteria
Inclusion Criteria:

- Patients scheduled for surgery with anticipated need for postoperative analgesia

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 non-steroidal anti-inflammatory drug (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