A study comparing the effects of a combination of paracetamol and ibuprofen with paracetamol alone or ibuprofen alone or placebo

Exclusion Criteria21

• Has taken any NSAID or paracetamol within 12 hours prior to the start of surgery other than aspirin less than or equal to 150mg/day.
• Subjects who have received any anaesthetics within 24 hours prior to surgery
• Hypersensitivity to oxycodone
• Administration of any intra-articular drug during the surgery including morphine, bupivacain, lidocaine or tramadol etc.
• Known hypersensitivity to oxycodone
• Known history of drug or alcohol abuse
• Known to be pregnant or possibly pregnant.
• Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the subject become sexually active, she must agree to use a double-barrier method of contraception). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral oophorectomy.
• Women of childbearing potential who are unwilling to undergo a urine pregnancy test
• Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective.
• In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
• Currently or in the last 30 days, has been in a clinical trial involving another study drug.
• Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator), cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations.
• Participant weight < 50kg or > 120 Kg.
• Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant’s best interests to participate in this study.
• NSAID and/or paracetamol contra-indications
• Hypersensitivity to aspirin or other NSAID.
• Hypersensitivity to paracetamol.
• Severe known haemopoetic, renal or hepatic disease, or immunosuppressed.
• History of gastric ulceration and bleeding or other GI disorders that, in the opinion of the investigator make the subject unsuitable (e.g., frequent treatment of GERD, inflammatory bowel disease, etc.).
• History of severe asthma defined as asthma requiring frequent or ongoing treatment to control symptoms. Exercise-induced asthma or mild asthma not requiring ongoing treatment may not be exclusionary at the discretion of the investigator.