Combination paracetamol and ibuprofen for pain relief after oral surgery: a dose ranging study
Abstract
PURPOSE: Combined paracetamol and ibuprofen has been shown to be more effective than either constituent alone for acute pain in adults, but the dose-response has not been confirmed. The aim of this study was to define the analgesic dose-response relationship of different potential doses of a fixed dose combination containing paracetamol and ibuprofen after third molar surgery.
METHODS: Patients aged 16 to 60 years with moderate or severe pain after the removal of at least two impacted third molars were randomised to receive double-blind study medication as two tablets every 6 h for 24 h of either of the following: two tablet, combination full dose (paracetamol 1000 mg and ibuprofen 300 mg); one tablet, combination half dose (paracetamol 500 mg and ibuprofen 150 mg); half a tablet, combination quarter dose (paracetamol 250 mg and ibuprofen 75 mg); or placebo. The primary outcome measure was the time-adjusted summed pain intensity difference over 24 h (SPID 24) calculated from the 100-mm VAS assessments collected over multiple time points for the study duration.
RESULTS: Data from 159 patients were included in the analysis. Mean (SD) time-adjusted SPID over 24 h were full-dose combination 20.1 (18.0), half dose combination 20.4 (20.8), quarter dose combination 19.3 (20.0) and placebo 6.6 (19.8). There was a significant overall effect of dose (p = 0.002) on the primary outcome. Planned pairwise comparisons showed that all combination dose groups were superior to placebo (full…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 159 participants or records.
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