Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
Condition: Pain
Intervention: Caldolor; Normal Saline
Intervention description: 800 milligrams intravenous; Placebo comparator
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative
      hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine
      the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of
      post-operative pain by patients self-assessment of pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled for elective hip or knee replacement, reconstruction or arthroplasty surgery
             with anticipated need for post-operative intravenous (IV) morphine analgesia with
             anticipated use of (greater than or equal to (≥) 28 hours.

          2. Adequate IV access

          3. Anticipated hospital stay ≥ 28 hours

        Exclusion Criteria:

          1. Be unable to make a reliable self-report of pain intensity to pain relief

          2. Less than 18 years of age

          3. Greater than 80 years of age

          4. Use of analgesics, muscle relaxants, NSAIDS and sedatives less than 12 hours prior to
             clinicaltrial material(CTM) administration with the following exceptions: paracetamol
             (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be
             administered until midnight the evening prior to surgery; muscle relaxants working at
             the neuromuscular junction used for intubation and/or anesthesia administration for
             the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam)
             used as a co-induction agent for the surgical procedure prior to CTM administration

          5. Patients taking warfarin, lithium, combination of angiotension converting
             enzyme(ACE)-inhibitors and furosemide

          6. Patients with anemia (active, clinically significant anemia) and/or a history or
             evidence of asthma or heart failure

          7. History of allergy or hypersensitivity to any component of Caldolor, aspirin (or
             aspirin related products), NSAIDs, or COX-2 inhibitors

          8. Pregnant or nursing

          9. History of severe head trauma that required current hospitalization, intracranial
             surgery or stroke within the previous 30 days, or any history of intracerebral
             arteriovenous malformation, cerebral aneurysm or CNS mass lesion

         10. Weigh less than 30 kilogram

         11. Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active
             clinically significant bleeding, or have underlying platelet dysfunction including
             (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular
             coagulation, or congenital platelet dysfunction

         12. Have gastrointestional (GI) bleeding that required medical intervention within the
             previous 6 weeks (unless definitive surgery has been performed)

         13. Have a platelet count less than 30,000 mm^3 determined within the 28 days prior to
             surgery

         14. Pre-existing dependence on narcotics or known tolerance to opioids

         15. 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

         16. Refusal to provide written authorization for use and disclosure of protected health
             information

         17. Be on dialysis, have oliguria or creatinine greater than 3.0 milligram/deciliter.

         18. Inability to achieve hemostasis or inability to close surgical incision, prior to
             Operating Room discharge

         19. Operative procedure includes organ transplant

         20. Pre or intra-operative procedure utilized for the prevention of pre- or post-operative
             pain (i.e. epidural or nerve blocks)

         21. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours
             before dosing (Prophylaxis with subcutaneous heparin is acceptable)

         22. Have received another investigational drug within the past 30 days

         23. Be otherwise unsuitable for the study in the opinion of the investigator