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Clinical Question
In patients with an acute musculoskeletal injury that does not warrant parenteral analgesia, does adding ibuprofen and codeine to acetaminophen (paracetamol) increase pain relief?
Bottom line
In patients with moderate pain at rest due to an acute sprain, fracture, or contusion, adding ibuprofen and codeine to treatment with acetaminophen does not produce additional pain relief at 1 or 2 hours after a single dose. 2b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Foundation
Setting: Emergency department
Synopsis
These researchers recruited 119 patients who presented to an emergency department with an acute musculoskeletal injury (sprain, fracture, or contusion) with a pain score of at least 4 of a possible 10 (average 5.8) who were deemed by the treating physician not to require parenteral analgesia. The patients were randomly assigned to receive a single dose of 1000 mg acetaminophen, either with placebo or in combination with 400 mg ibuprofen and 60 mg codeine. Allocation to treatment was concealed from the clinician and researchers. Using intention-to-treat analysis, pain reduction at rest was similar in both groups after 1 hour: a decrease of 1.6 in the acetaminophen/placebo group and 2.0 in the combination analgesic group (difference = .4; P = .26). After 2 hours, pain reduction at rest was still similar with both treatments. Reduction in pain with activity was statistically greater with combination analgesia (3.0 vs 1.9; P = .04), but this difference, on average, did not meet the threshold for clinical relevance (a difference of 1.3). Almost 3 times as many (relative risk = 2.8) patients who received the combination reported a minor adverse effect than did patients who received acetaminophen alone. The study had a 90% power to find a difference at 60 minutes if one existed.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA