Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare the effectiveness and of perioperative use of Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.

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

Details

• Lead Sponsor: Anita Gupta
• Collaborator: Cumberland Pharmaceuticals
• Treatments: Acetaminophen; Anesthetics; Ibuprofen

Criteria

Inclusion Criteria:

• Adult patients age 18-70 scheduled for total knee or hip arthroplasty surgery

• American Society of Anesthesiology physical status I, II, III

Exclusion Criteria:

• Impaired liver function

• History of substance abuse or chronic pain

• Patients known to be hypersensitive to any of the components of Caldolor or Ofirmev

• Patients less than 18 years of age.

• Inability to understand the requirements of the study or be unwilling 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.

• Be pregnant or nursing

• Be otherwise unsuitable for the study, in the opinion of the Investigator.