A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Ibuprofen; Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Patients scheduled for knee arthroscopy

Exclusion Criteria:

• Inadequate intravenous (IV) access.

• History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.

• Less than 18 years of age.

• Use of analgesics less than 8 hours prior to surgery.

• Patients with active, clinically significant anemia.

• History or evidence of asthma or heart failure.

• Pregnant.

• Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.

• 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 and to return for the required assessments.

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