Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients

Study Overview
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Brief Summary
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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

Official Title
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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients

Conditions
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Pain

Intervention / Treatment
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* Other: Normal saline as placebo comparator
* Drug: Intravenous ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective abdominal hysterectomy surgery with anticipated need for post-operative I.V. morphine analgesia with anticipated use of ≥ 24 hours. Adequate IV access Anticipated hospital stay ≥ 24 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 70 years of age Use of NSAIDs within 12 hours prior to dosing 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 Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide Patients with anemia (active clinically significant) 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 30kg 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 Have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed) Have a platelet count less than 30,000mm3 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 calculated creatinine clearance of less than 60 mL/min (calculated using the Cockcroft and Gault formula) determined within the 28 days prior to surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous ibuprofen<br> | Drug: Intravenous ibuprofen<br>* 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)<br>* Other names: Caldolor;|
| Placebo Comparator: normal saline<br> | Other: Normal saline as placebo comparator<br>* 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)<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery | 24 Hours |