Tramadol/acetaminophen tablets in the treatment of postsurgical orthopedic pain.
Tramadol/acetaminophen (APAP) combination tablets were shown effective and safe for postsurgical orthopedic pain in a 6-day, multicenter, randomized, double-blind, active- and placebo-controlled study. Of 305 intent-to-treat (ITT) postsurgical patients, 153 patients undergoing arthroscopy who had at least moderate pain were randomized to receive either tramadol 37.5 mg/APAP 325 mg (mean, 4.3 tablets), or codeine 30 mg/APAP 300 mg (mean, 4.6 tablets), or placebo. Tramadol/APAP was superior to placebo for the following outcome variables: total pain relief (TOTPAR, P = .013), sum of pain intensity differences (SPID, P = .049), sum of total pain relief and sum of pain intensity differences (SPRID, P = .018), and average daily pain relief (P = .031). Similar incidence of adverse events for tramadol/APAP and codeine/APAP was found, except for constipation (0% vs 10.9%) and vomiting (8.2% vs 16.4%).
Bourne
Michael H
MH
Division of Orthopedic Surgery, St. Mark's Hospital, Salt Lake City, Utah, USA. mhbourne@msn.com
Rosenthal
Norman R
NR
Xiang
Jim
J
Jordan
Donna
D
Kamin
Marc
M
D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000704:Analysis of Variance; D003061:Codeine / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009985:Orthopedics; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D014147:Tramadol / Q000627:therapeutic use*; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D000082:Acetaminophen; D014147:Tramadol; D003061:Codeine