Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in adolescents between the ages of 12 and \<18 years.
What will the study involve for participants?
* Participants will be randomly allocated to one of 3 treatment groups:
* 3 tablets of Combogesic® 325, * 2 tablets of Combogesic® 325 and 1 tablet of placebo or * 2 tablets of acetaminophen1000mg and 1 tablet of placebo * Participants will take 3 tablets every 6 hours with a maximum of 4 doses in 24 hours * Participants and study doctor will be blinded to the treatment group * If pain is not sufficiently controlled, opioids may be used as supplementary pain relief at the discretion of the study doctor. * Participants will complete a patient diary to assess their pain * Participants will rate the study drug at the end of the treatment.
It is expected that Combogesic® tablets (either 2 or 3 tablets per dose) will provide a greater reduction in pain compared to acetaminophen (1000 mg) treatment.
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.
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**