Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain.
The objective of this double-masked, parallel-group, multicenter, inpatient study was to compare bromfenac with an acetaminophen/oxycodone combination and ibuprofen in patients who had pain due to abdominal gynecologic surgery. In the 8-hour, single-dose phase, 238 patients received single oral doses of bromfenac (50 or 100 mg), acetaminophen 650 mg/oxycodone 10 mg, ibuprofen 400 mg, or placebo. In the multiple-dose phase, 204 patients received bromfenac, acetaminophen/oxycodone, or ibuprofen for up to 5 days. In the single-dose phase, both bromfenac doses produced peak analgesic responses equivalent to acetaminophen/oxycodone, but the responses to bromfenac were longer lasting. Bromfenac produced significantly better overall (8-hour) analgesic summed scores than acetaminophen/oxycodone. Ibuprofen was less efficacious than the other analgesics. The remedication rate was lower in both bromfenac groups than in the other treatment groups. The acetaminophen/oxycodone group reported more somnolence and vomiting. Single doses of bromfenac provided analgesia at least equivalent to that of the acetaminophen/oxycodone combination, with a longer duration of action. Both doses of bromfenac and acetaminophen/oxycodone were superior to ibuprofen in this study.
Johnson
G H
GH
Latter Day Saints Hospital, Salt Lake City, USA.
Van Wagoner
J D
JD
Brown
J
J
Cooper
S A
SA
D000082:Acetaminophen / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D001577:Benzophenones / Q000627:therapeutic use*; D001969:Bromobenzenes / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005836:Genitalia, Female / Q000601:surgery; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008875:Middle Aged; D010098:Oxycodone / Q000627:therapeutic use*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D001577:Benzophenones; D001969:Bromobenzenes; D004338:Drug Combinations; D000082:Acetaminophen; C053083:bromfenac; D010098:Oxycodone; D007052:Ibuprofen