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

Inclusion Criteria:

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

2. Being scheduled for elective single surgical site orthopaedic surgery (hip or kneejoint 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 regionalanalgesia after surgery.

4. Having anticipated need for postoperative narcotic analgesia administered by patientcontrolled 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 oraspirin.

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 oraspirin 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 orstroke within the previous 30 days, or any history of intracerebral arteriovenousmalformation, cerebral aneurism or CNS mass lesion.

8. History of congenital bleeding diathesis or any active clinically significant bleedingor 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 studyrestrictions or to return for the required assessments.