Clinical trial NCT00225732: Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cooper Green Hospital / Jefferson Clinic
state: Alabama
city: Birmingham
country: United States
facility: Medical Center East / Alabama Clinical Therapeutics
state: Alabama
city: Mobile
country: United States
facility: Springhill Hospital / Wilmax Clinical Research, Inc.
state: Alabama
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.
state: Alabama
city: Montgomery
country: United States
facility: Jackson Hospital / Drug Research and Analysis Corporation
state: Alabama
city: Montgomery
country: United States
facility: Baptist Medical Center South / Drug Research and Analysis Corporation
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Colton
country: United States
facility: Valley OB/GYN
state: California
city: Wichita
country: United States
facility: Research Support Personnel LLC
state: Kansas
city: Lexington
country: United States
facility: Chandler Medical Center; Ken Muse Research
state: Kentucky
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists
state: Tennessee
city: Fort Worth
country: United States
facility: Health First Medical Group
state: Texas
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
Study officials:
References:
citation: Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.