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

NCT ID: NCT00225732

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-01-31

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

intravenous ibuprofen

Group Type: ACTIVE_COMPARATOR

Intravenous ibuprofen

Intervention Type: DRUG

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)

normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline as placebo comparator

Intervention Type: OTHER

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)

Interventions

Normal saline as placebo comparator

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)

Intervention Type: OTHER

Intravenous ibuprofen

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 Type: DRUG

Other Intervention Names

NS; Caldolor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cooper Green Hospital / Jefferson Clinic

Birmingham, Alabama, United States

Medical Center East / Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Springhill Hospital / Wilmax Clinical Research, Inc.

Mobile, Alabama, United States

Mobile Infirmary Medical Center / Wilmax Clinical Research, Inc.

Mobile, Alabama, United States

Jackson Hospital / Drug Research and Analysis Corporation

Montgomery, Alabama, United States

Baptist Medical Center South / Drug Research and Analysis Corporation

Montgomery, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Valley OB/GYN

Colton, California, United States

Research Support Personnel LLC

Wichita, Kansas, United States

Chandler Medical Center; Ken Muse Research

Lexington, Kentucky, United States

Comprehensive Pain Specialists

Hendersonville, Tennessee, United States

Health First Medical Group

Fort Worth, Texas, United States

Royal Adelaide Hospital

Adelaide, , Australia

Countries

United States; Australia

References

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.

Reference Type: DERIVED

PMID: 19843482 (View on PubMed)

Other Identifiers

CPI-CL-008

Identifier Type: -

Identifier Source: org_study_id