The combination of acetaminophen, codeine, and caffeine (Tylenol 3, T3) is a standard postoperative analgesia after breast surgery despite the adverse effects and variable efficacy of narcotics. This study compared the efficacy of a nonnarcotic approach (acetaminophen and ibuprofen; AcIBU) to T3 after outpatient breast surgery.
This double-blind randomized equivalence trial involved patients undergoing outpatient breast surgery. Patients were randomized (stratified by procedure type) to receive AcIBU or T3 four times daily for 7 days, or until free of pain. Pain intensity, measured four times daily by the visual analog scale, was the primary outcome; secondary outcomes were pain relief with analgesic, days until freedom from pain, adverse effects, discontinuation of drug as a result of adverse effects, and patient satisfaction.
There were 71 patients randomized to AcIBU and 70 patients to T3. Repeated measures analysis showed no significant difference in average pain intensity over 7 days (AcIBU 19.9 mm vs. T3 20.6 mm; P = 0.78). Similarly, there was no significant difference in pain relief with analgesic (P = 0.46). Although no difference in the incidence of adverse effects was observed (P = 0.94), discontinuation of the study drug as a result of adverse effects was more common with T3 (19 % vs. 6 %; P = 0.018). No significant differences were identified in days until freedom from pain or patient satisfaction; 92 % of AcIBU and 89 % of T3 patients were satisfied with their pain control (P = 0.55).
AcIBU is a safe, effective method of pain control after outpatient breast surgery. Compared to T3, it provides at least equivalent analgesia and has a more tolerable adverse effect profile.
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Funded by a Capital District Health Authority Research grant and the Ramia Chair in Surgical Oncology Research. Lucy Helyer, MD, FRCSC, Trevor Topp, MD, FRCSC, FACS, Virginia Calverly, MD, FRCSC, and Carmen Giacomantonio, MD, FRCSC, greatly contributed by recruiting their patients to this trial. We thank Kevin Druhan for his assistance in data entry and management; Hoan Linh Banh, PhD, for her assistance with the pharmacy; and the clinic and perioperative nursing staff at the Victoria General Hospital and IWK Hospital in Halifax, Nova Scotia, for their enthusiastic support of this study.
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Mitchell, A., McCrea, P., Inglis, K. et al. A Randomized, Controlled Trial Comparing Acetaminophen Plus Ibuprofen versus Acetaminophen Plus Codeine Plus Caffeine (Tylenol 3) after Outpatient Breast Surgery. Ann Surg Oncol 19, 3792–3800 (2012). https://doi.org/10.1245/s10434-012-2447-7
- Visual Analog Scale
- Visual Analog Scale Score