A randomized, controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine (Tylenol 3) after outpatient breast surgery.
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.
Department of Surgery, Dalhousie University and Capital District Health Authority, Halifax, NS, Canada.
Alex
A
Mitchell
Patrick
P
McCrea
Karen
K
Inglis
Geoffrey
G
Porter
D000082:Acetaminophen / Q000008:administration & dosage*; D000328:Adult; D000556:Ambulatory Surgical Procedures / Q000009:adverse effects; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy / Q000601:surgery*; D002110:Caffeine / Q000008:administration & dosage*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage; D003061:Codeine / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008875:Middle Aged; D009294:Narcotics / Q000008:administration & dosage; D009367:Neoplasm Staging; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D062606:Tertiary Care Centers
D018712:Analgesics, Non-Narcotic; D000697:Central Nervous System Stimulants; D009294:Narcotics; D000082:Acetaminophen; D002110:Caffeine; D003061:Codeine; D007052:Ibuprofen