A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biomendi S.A.U.
• Collaborator: Pivotal S.L.
• Treatments: Ibuprofen; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Men or women between 18 and 80 years old.

2. Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)

3. Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.

4. Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).

5. Expected to stay at the hospital for at least 24 h.

6. Providing written informed consent for participating in this study.

Exclusion Criteria:

1. Use of NSAID within 12 hours prior to the first planned dose.

2. Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.

3. Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.

4. History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.

5. Pregnant or nursing.

6. Weight less than 40 kg.

7. History of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.

8. History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.

9. Gastrointestinal bleeding that required medical intervention.

10. Platelet count less than 80.000 determined within the 28 days prior to surgery.

11. Pre-existing dependence on narcotics or receiving chronic treatment with opioids.

12. Severe renal failure (calculated creatinine clearance < 60 ml/min).

13. Liver failure, ALAT or ASAT >3 times upper limit of normality, or bilirubin >2 g/dl.

14. Diagnosed of Bowel Inflammatory Disease.

15. Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.