Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain

Objective: The objective of this study was to compare the effectiveness of combination hydrocodone and ibuprofen with that of combination oxycodone an d acetaminophen in the treatment of moderate to severe postoperative obstet ric or gynecologic pain. Background: Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved f ixed-dose combination analgesic containing an opioid and ibuprofen. Methods: This randomized, double-blind, parallel-group, single-dose, active -comparator, placebo-controlled study compared the effects of a 2-tablet do se of hydrocodone 7.5 mg and ibuprofen 200 mg with those of a 2-tablet dose of oxycodone 5 mg and acetaminophen 325 mg and placebo. Analgesia was asse ssed over 8 hours. Results: Mean pain relief (PR) scores were similar for the hydrocodone with ibuprofen and oxycodone with acetaminophen groups (n = 61 and 59, respecti vely) at 0.5, 1, 1.5, 2, 2.5, 3, 4, and 7 hours and significantly greater f or the hydrocodone with ibuprofen group at 5, 6, and 8 hours (P less than o r equal to 0.05). Mean pain intensity difference (PID) scores were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours and significantly greater for hydrocodone with ibuprofen at 5, 6, 7, and 8 hours (P less than or equal to 0.05). Total PR scores were similar for hydrocodone with ibuprofen and oxycodone with aceta minophen for the 0- to 3- and 0- to 4-hour intervals and significantly grea ter for hydrocodone with ibuprofen for the 0- to 6- and 0- to 8-hour interv als (P < 0.05). The sum of the PID scores was similar for hydrocodone with ibuprofen and oxycodone with acetaminophen for the 0- to 3-, 0- to 3-, 0- t o 6-, and 0- to 8-hour intervals. The median estimated time to onset of ana lgesia, mean peak PR score, median time to remedication, and mean global as sessment score were similar for hydrocodone with ibuprofen and oxycodone wi th acetaminophen. Assay sensitivity was demonstrated by the presence of sta tistically significant differences between both active treatments and place bo (n = 60). The number of patients experiencing adverse events was similar for each of the 3 groups (11 [18.0%], hydrocodone with ibuprofen; 7 [11.9% ], oxycodone with acetaminophen; and 6 [10.0%], placebo). Conclusions: In this study, a 2-tablet dose of combination hydrocodone 7.5 mg and ibuprofen 200 mg was as effective as a 2-tablet dose of combination oxycodone 5 mg and acetaminophen 325 mg in the treatment of moderate to sev ere postoperative obstetric or gynecologic pain. Both treatments were super ior to placebo. The results of this study suggest that the combination of h ydrocodone 7.5 mg and ibuprofen 200 mg may offer prescribers an additional option in combination pain therapy.