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Hydrocodone/acetaminophen equivalent to codeine/acetaminophen for acute pain

Clinical Question:
Is hydrocodone/acetaminophen superior to codeine/acetaminophen for pain management in adult patients with acute extremity pain?

Bottom Line:
Pain improvement, side effects, and patient satisfaction were similar with hydrocodone/acetaminophen and codeine/acetaminophen in adults presenting to the emergency department with acute extremity pain. If hydrocodone/acetaminophen is reclassified as a Schedule II narcotic it may be less cumbersome for clinicians to prescribe the codeine/acetaminophen combination Schedule III narcotic. (LOE = 1b)

Chang AK, Bijur PE, Munjal KG, John Gallagher E. Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge. Acad Emerg Med 2014;21(3):228-235.  [PMID:24628747]

Study Design:
Randomized controlled trial (double-blinded)

Self-funded or unfunded


Emergency department

The Federal Drug Administration is likely to reclassify hydrocodone from a Schedule III narcotic to a Schedule II narcotic, while leaving codeine unchanged as a Schedule III narcotic. These investigators identified 240 adults, aged 21 to 64 years, presenting to the emergency department with acute extremity pain of less than 7 days duration distal to and including the shoulder or hip joint. Eligible patients randomly received (concealed allocation assignment) a 3-day course of hydrocodone/acetaminophen (5 mg/500 mg) or the identical-appearing codeine/acetaminophen (30 mg/300 mg) with instructions to take 2 tablets every 4 hours as needed for pain (daily maximum dose = 12 capsules). All study personnel, including the patients who self-assessed pain using daily dairies, remained masked to treatment group assignment. The first 35 patients randomized were not included in the results because of changes in the data collection instrument, and an additional 24 patients did not take any prescribed medications; thus, the final per-protocol sample consisted of 181 randomized patients. Complete follow-up occurred for a median time from emergency department discharge of 26 hours (range = 24 - 39 hours). No significant group differences were reported for pain improvement, side effects, or patient satisfaction. The study was 80% powered to detect a predetermined clinically significant difference in pain improvement. Note that this study focused on adults with acute extremity pain. There have been several safety concerns published regarding codeine for children and for other types of pain.


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