The efficacy of rofecoxib 50 mg and hydrocodone/acetamino­phen 7.5/750 mg in patients with post-arthroscopic pain

ABSTRACTObjective: To compare the efficacy and tolerability of rofecoxib, hydrocodone/acetaminophen 7.5 mg/750 mg (H/A) and placebo in treating pain after arthroscopy of the knee.Methods: A randomized, double-blind, placebo-controlled, single dose study enrolling patients experiencing moderate or severe pain after knee arthroscopy. Patients with moderate-to-severe postoperative pain received either rofecoxib 50 mg (n = 151), H/A (n = 145), or placebo (n = 147). Pain was measured over 24 h. The primary endpoint was total pain relief at 6 h for rofecoxib 50 mg compared with placebo.Results: H/A ( p = 0.003), but not rofecoxib ( p = 0.256) was significantly more effective than placebo for total pain relief at 6 h (TOPAR6). Although analgesic onset and peak were significantly better for H/A than for both rofecoxib ( p < 0.01, p < 0.05, respectively) and placebo ( p < 0.05, p < 0.001, respectively), rofecoxib patients used significantly less rescue analgesia ( p < 0.001) over 24 h. Rofecoxib also provided bett...