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Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Low Back Pain: An Emergency Department–based Randomized Study
Author(s) -
Friedman Benjamin W.,
Irizarry Eddie,
Chertoff Andrew,
Feliciano Carmen,
Solorzano Clemencia,
Zias Eleftheria,
Gallagher E. John
Publication year - 2020
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/acem.13898
Subject(s) - medicine , ibuprofen , acetaminophen , placebo , emergency department , randomized controlled trial , visual analogue scale , low back pain , anesthesia , physical therapy , clinical endpoint , alternative medicine , pathology , psychiatry , pharmacology
Objectives Patients with low back pain (LBP) are often treated with nonsteroidal anti‐inflammatory drugs (NSAIDs). NSAIDs are modestly effective for LBP, but many patients with LBP continue to suffer despite treatment with these medications. We compared pain and functional outcomes 1 week after emergency department (ED) discharge among patients randomized to a 1‐week course of ibuprofen plus acetaminophen versus ibuprofen plus placebo. Methods This was a randomized, double‐blind study conducted in two urban EDs. Patients presenting with acute, nontraumatic, nonradicular LBP of no more than 2 weeks’ duration were eligible for enrollment immediately prior to discharge from an ED if they had a score > 5 on the Roland Morris Disability Questionnaire (RMDQ), a 24‐item validated instrument, indicating more than minimal functional impairment. All patients were given a standardized 10‐minute LBP educational session prior to discharge. The primary outcome was improvement on the RMDQ between ED discharge and 1 week later. One secondary outcome was pain intensity, as measured on a 4‐point descriptive scale (severe, moderate, mild, none) at 1 week. Results Enrollment began in October 2018. A total of 120 patients met selection criteria and were randomized. Baseline demographic characteristics were comparable between the two groups. By 1 week after the ED visit, patients randomized to ibuprofen plus placebo reported a mean (±SD) improvement in the RMDQ of 11.9 (±9.7), while those randomized to ibuprofen plus acetaminophen reported a mean (±SD) improvement of 11.1 (±10.7). The 95% CI for the between‐group difference of 0.8 was −3.0 to 4.7. At 1 week, moderate or severe pain was reported by 15 of 53 (28%) patients in the ibuprofen plus placebo group and 16 of 57 (28%) patients in the ibuprofen plus acetaminophen group (95% CI for between‐group difference of 0% = −17% to 17%). Conclusion Among ED patients with acute, nontraumatic, nonradicular LBP, adding acetaminophen to ibuprofen does not improve outcomes within 1 week.