Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of postoperative pain: a double-blind, placebo- and active-controlled parallel-group study.
OBJECTIVE
This study compared the efficacy and safety of a single dose of oxycodone 5 mg/ibuprofen 400 mg versus its individual components and placebo in a third-molar extraction model.


METHODS
In this multicenter, double-blind, double-dummy, parallel-group investigation, subjects with moderate to severe pain within 5 hours after extraction of > or =2 ipsilateral bony impacted third molars were randomized to single doses of oxycodone 5 mg/ibuprofen 400 mg, ibuprofen 400 mg, oxycodone 5 mg, or placebo. Primary efficacy variables were the sum of pain intensity difference over 6 hours (SP1D6) and total pain relief through 6 hours (TOTPAR6). The pharmacokinetics of oxycodone and ibuprofen, alone and in combination, were also determined in a subset of patients.


RESULTS
A total of 498 subjects were randomized to treatment (187 to oxycodone 5 mg/ibuprofen 400 mg, 186 to ibuprofen 400 mg, 63 to oxycodone 5 mg, and 62 to placebo). Baseline demographics were generally similar among treatment groups, despite differences in sex (P = 0.041) and race (P = 0.023). Combination therapy was associated with greater analgesia than ibuprofen alone, oxycodone alone, or placebo (mean [SE] TOTPAR6: 13.3 [0.52], 12.2 [0.52], 4.3 [0.82], and 4.2 [0.83], respectively [P < 0.001 vs oxycodone or placebo, P = 0.012 vs ibuprofen]; mean [SE] SP1D6: 6.54 [0.42], 5.41 [0.44], 0.14 [0.60], and 0.32 [0.59], respectively [P < 0.001 vs oxycodone or placebo, P = 0.002 vs ibuprofen]). Combination therapy was well tolerated. Pharmacokinetic results implied no interaction between oxycodone and ibuprofen.


CONCLUSIONS
In this study, a single dose of oxycodone 5 mg/ibuprofen 400 mg was fast-acting, effective, and well tolerated in subjects with moderate to severe pain after dental surgery. Oxycodone 5 mg alone did not provide an efficacy benefit over placebo in this study.
Van Dyke
Thomas
T
Goldman School of Dental Medicine, Boston University, 100 East Newton Street, Rm. 107, Boston, MA 02118, USA. tvandyke@bu.edu
Litkowski
Leonard J
LJ
Kiersch
Theodore A
TA
Zarringhalam
Nooshin Majd
NM
Zheng
Hongjie
H
Newman
Kenneth
K
D000328:Adult; D000701:Analgesics, Opioid / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006207:Half-Life; D006801:Humans; D007052:Ibuprofen / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008964:Molar, Third; D010098:Oxycodone / Q000493:pharmacokinetics / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000145:classification / Q000188:drug therapy*; D014081:Tooth Extraction
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D010098:Oxycodone; D007052:Ibuprofen