Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
Condition: Burns
MeSH terms: Burns
Intervention: Caldolor; Placebo
Intervention description: 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours; Placebo
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: 61.0
Sex: All
Healthy volunteers: No

Summary:

      The primary objective of this study of Caldolor administered to hospitalized adult and
      pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when
      compared to placebo when administered every 6 hours for at least 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with second and/or third degree thermal burns covering more than 10 percent
             total body surface area (including face) with anticipated hospital stay greater than
             72 hours.

          2. Adequate intravenous access

          3. Have fever, documented by temperature greater than or equal to 38.0 degree celsius
             (100.4 degree fahrenheit)

        Exclusion Criteria:

          1. Patients with electric burns

          2. Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever
             reducing medications within 4 hours prior to dosing

          3. Patients taking warfarin or lithium

          4. Active, clinically significant asthma

          5. History of allergy or hypersensitivity to any component of intravenous ibuprofen,
             NSAIDs, aspirin (or related products), or COX-2 inhibitors

          6. Pregnant or nursing

          7. 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 aneurism or central nervous system mass lesion

          8. 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

          9. Have gastrointestional bleeding that required medical intervention within the previous
             6 weeks (unless definitive surgery has been performed)

         10. Have a platelet count less than 20,000 mm^3

         11. Be on dialysis

         12. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours
             before dosing (clopidogrel, prophylaxis with enoxaparin or subcutaneous heparin is
             acceptable)

         13. 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
             (If the patient is incapacitated, informed consent will be sought from a legally
             acceptable representative.)

         14. Refusal to provide written authorization for use and disclosure of protected health
             information (If the patient is incapacitated, informed consent will be sought from a
             legally acceptable representative.)

         15. Have received another investigational drug within the past 30 days

         16. Be otherwise unsuitable for the study in the opinion of the investigator