A study comparing the effects of different paracetamol and ibuprofen combination doses and placebo

Exclusion Criteria19

• Study contra-indications
• 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 anesthetics from midnight the night prior to surgery, except for lidocaine with epinephrine, nitrous oxide, diazepam (Valium [Registered Trademark]), methohexitol (Brevital[Registered Trademark]).
• Hypersensitivity to opioids
• 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.
• 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 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.