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**
Parallel
Combogesic® tablets
DrugThe active ingredients of Combogesic® tablets are acetaminophen 325 mg and ibuprofen 97.5 mg.
Acetaminophen 500mg
DrugEach tablet contains acetaminophen 500mg.
Placebo
DrugPlacebo tablets do not contain any active ingredients
Time-adjusted summed pain intensity difference (SPID) calculated from the visual analogue scale (VAS) pain intensity scores 6 hours after first dose of study medication
SPID will be derived from the 100 mm Visual Analogue Scale which is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable). The primary analysis will compare three tablets of Combogesic® against acetaminophen
Time-adjusted SPID0-6 (for 2 tablets of Combogesic vs. acetaminophen) and Time-adjusted SPID0-12, SPID0-18 and SPID0-24 for both doses.
The time to onset of pain relief after the first dose of study drug defined as (i) perceptible, (ii) meaningful and (iii) complete pain relief using the three stopwatch method.
The maximum VAS pain scores up to 24 hours after the first dose of study medication.
100 mm Visual Analogue Scale is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable)
The pain intensity (PI) and pain intensity difference (PID) at 6, 12, 18, and 24 hours after first dose.
100 mm Visual Analogue Scale which is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable). The PID will be measured by the difference between the baseline score and the score at 6, 12, 18, and 24 hours after first dose.
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