Abstract

BACKGROUND
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
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.

Links

Publisher Full Text

Authors

Mitchell A, McCrea P, Inglis K, Porter G

Institution

Department of Surgery, Dalhousie University and Capital District Health Authority, Halifax, NS, Canada.

Source

Annals of surgical oncology 19:12 2012 Nov pg 3792-800

MeSH

Acetaminophen
Adult
Ambulatory Surgical Procedures
Analgesics, Non-Narcotic
Breast Neoplasms
Caffeine
Central Nervous System Stimulants
Codeine
Double-Blind Method
Drug Therapy, Combination
Female
Follow-Up Studies
Humans
Ibuprofen
Middle Aged
Narcotics
Neoplasm Staging
Pain, Postoperative
Postoperative Complications
Prognosis
Prospective Studies
Tertiary Care Centers

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22713999