A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

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

Details

• Lead Sponsor: Culpeper Surgery Center
• Collaborator: Cumberland Pharmaceuticals
• Treatments: Analgesics; Ibuprofen; Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery

Exclusion Criteria:

• Inadequate IV access.

• History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.

• Less than 18 years of age or Greater than 65 years of age.

• Use of analgesics, including NSAIDs, less than 12 hours prior to surgery.

• Patients with active, clinically significant anemia.

• History or evidence of asthma or heart failure.

• Pregnant.

• 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.

• Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.

• Patients with known OSA