Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
Condition: Pain
Intervention: Normal saline as placebo comparator; Intravenous ibuprofen
Intervention description: 250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5); 800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours.
Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
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: 319.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative
      hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of
      Caldolor compared to placebo for the treatment of post-operative pain as measured by
      reduction in the requirement for the narcotic analgesic, morphine, post surgery
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled for elective abdominal hysterectomy surgery with anticipated need for
             post-operative I.V. morphine analgesia with anticipated use of ≥ 24 hours.

          2. Adequate IV access

          3. Anticipated hospital stay ≥ 24 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 70 years of age

          4. Use of NSAIDs within 12 hours prior to dosing

          5. Use of analgesics, muscle relaxants and sedatives less than 24 hours prior to 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

          6. Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide

          7. Patients with anemia (active clinically significant) and/or a history or evidence of
             asthma or heart failure

          8. History of allergy or hypersensitivity to any component of Caldolor, aspirin (or
             aspirin related products), NSAIDs, or COX-2 inhibitors

          9. Pregnant or nursing

         10. 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

         11. Weigh less than 30kg

         12. Have a history of congenital bleeding diathesis (eg 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

         13. Have GI bleeding that required medical intervention within the previous 6 weeks
             (unless definitive surgery has been performed)

         14. Have a platelet count less than 30,000mm3 determined within the 28 days prior to
             surgery

         15. Pre-existing dependence on narcotics or known tolerance to opioids

         16. 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

         17. Refusal to provide written authorization for use and disclosure of protected health
             information

         18. Be on dialysis, have oliguria or calculated creatinine clearance of less than 60
             mL/min (calculated using the Cockcroft and Gault formula) determined within the 28
             days prior to surgery

         19. Inability to achieve hemostasis or inability to close surgical incision, prior to
             Operating Room discharge

         20. Operative procedure includes organ transplant

         21. Pre or intra-operative procedure utilized for the prevention of pre- or post-operative
             pain (i.e. epidural or nerve blocks)

         22. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours
             before dosing (Prophylaxis with subcutaneous heparin is acceptable)

         23. Have received another investigational drug within the past 30 days

         24. Be otherwise unsuitable for the study in the opinion of the investigator