A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery

Inclusion Criteria: * Provide written informed consent or consent be provided from parents/legal guardians and assent from participants (where appropriate). * Be males and females aged at least 12 years and less than 18 years old on both the day of consent and throughout the 24 hour study period. * Be undergoing planned orthopedic surgery which requires at least 24 hours of hospital inpatient stay. * Have a clinical indication of acute moderate or severe pain (at least ≥ 50 mm on the VAS scale\*) within 6 hours after the completion of surgery associated with orthopedic surgery. * using a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable, patients should have a resting VAS pain intensity score of ≥ 50 mm for inclusion. For this study, moderate pain is defined as ≥ 40 mm to ≤ 69 mm and severe pain is defined as a resting VAS of ≥ 70 mm to ≤ 100 mm. * Have negative HIV and hepatitis B \& C test results. Exclusion Criteria: * Has taken any NSAID or acetaminophen containing drug products within 5 half-lives prior to the initial dose of study drug. * Hypersensitivity to opioids, NSAIDs or acetaminophen or a history of severe/serious drug reaction to NSAIDs or acetaminophen. * Pregnant or lactating females Known to be pregnant or possibly pregnant. * Sexually active females of childbearing potential not using adequate contraception\* and sexually active males not using adequate contraception\*\* * Women of childbearing potential who are unwilling to take adequate c…