ANALGESIC EFFICACY OF CONTROLLED-RELEASE OXYCODONE IN POSTOPERATIVE PAIN

The efficacy and safety of graded doses (10, 20, and 30 mg) of control led-release (CR) oxycodone was compared with that of immediate-release (IR) oxycodone (15 mg), immediate-release oxycodone 10 mg in combinat ion with acetaminophen 650 mg (APAP), and placebo in a single-dose, do uble-blind, randomized, parallel-group study. The participants, 182 in patients experiencing moderate to severe pain after abdominal or gynec ologic surgery, provided hourly ratings of pain intensity and relief f or 12 hours after administration. All active treatments were significa ntly superior to placebo for many hourly measurements and for the sum of pain intensity differences (SPID) and total pain relief (TOTPAR). A dose response was found among the three levels of CR oxycodone for pa in relief and peak pain intensity difference (PID), with the 20- and 3 0-mg doses being significantly better than the 10-mg dose. For all act ive treatments, peak PID and peak pain relief occurred approximately 2 to 4 hours after administration. The median time to onset of relief w as 32 minutes for oxycodone plus APAP, 41 minutes for IR oxycodone, an d 46 minutes for CR oxycodone 30 mg. Duration of pain relief showed th at the 10-, 20-, and 30-mg doses of CR oxycodone had durations of acti on of 10 to 12 hours compared with IR oxycodone and oxycodone plus APA P (both approximately 7 hours). Typical adverse events, particularly s omnolence, occurred in all active treatment groups. Treatment with CR oxycodone was safe and effective in this study, and its characteristic s will be beneficial in the treatment of pain.