Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

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.
Adequate IV access
Anticipated hospital stay ≥ 28 hours

Exclusion Criteria:

Be unable to make a reliable self-report of pain intensity to pain relief
Less than 18 years of age
Greater than 80 years of age
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
Patients taking warfarin, lithium, combination of angiotension converting enzyme(ACE)-inhibitors and furosemide
Patients with anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
History of allergy or hypersensitivity to any component of Caldolor, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
Pregnant or nursing
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
Weigh less than 30 kilogram
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
Have gastrointestional (GI) bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
Have a platelet count less than 30,000 mm^3 determined within the 28 days prior to surgery
Pre-existing dependence on narcotics or known tolerance to opioids
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
Be on dialysis, have oliguria or creatinine greater than 3.0 milligram/deciliter.
Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge
Operative procedure includes organ transplant
Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)
Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)
Have received another investigational drug within the past 30 days
Be otherwise unsuitable for the study in the opinion of the investigator