ANALGESIC EFFICACY OF A HYDROCODONE WITH IBUPROFEN COMBINATION COMPARED WITH IBUPROFEN ALONE FOR THE TREATMENT OF ACUTE POSTOPERATIVE PAIN

Hydrocodone is a semisynthetic opioid with analgesic and antitussive p roperties qualitatively similar to other opioid agonists. Ibuprofen is a nonsteroidal antiinflammatory agent with analgesic and antipyretic activity and is an effective, primarily peripheral-acting antiinflamma tory analgesic. The objective of this clinical trial was to determine the additive analgesic effect of the combination of 15 mg hydrocodone bitartrate with 400 mg ibuprofen, relative to 400 mg ibuprofen alone a nd placebo, in the treatment of postoperative pain. The single-dose an algesic efficacy of the combination of hydrocodone bitartrate with ibu profen was compared with ibuprofen alone and placebo in 120 patients w ith moderate or severe postoperative pain after abdominal surgery. Ana lgesia was measured during the 6-hour period after dosing based on ons et of relief, hourly and summary variables, and duration of effect. A significantly greater proportion of patients treated with the hydrocod one/ibuprofen combination reported onset of relief compared with ibupr ofen or placebo; however, the distribution functions for time to onset of relief did not differ among treatments. Hydrocodone with ibuprofen and ibuprofen alone were significantly more effective than placebo fo r all measures of analgesia. The combination of hydrocodone with ibupr ofen was significantly superior to ibuprofen for all hourly analgesic evaluations, weighted sum of pain intensify differences (SPID), total pain relief (TOTPAR), and global rating of study medication, No patien ts in the hydrocodone with ibuprofen group required analgesic remedica tion during the 6-hour study period, compared with 25% and 82% in the ibuprofen and placebo groups, respectively. The analgesic superiority of 15 mg hydrocodone bitartrate combined with 400 mg ibuprofen compare d with 400 mg ibuprofen alone was demonstrated across many efficacy va riables.