OBJECTIVE: 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 better Brief Pain Inventory Severity (p = 0.008) and Interference Domain (p = 0.045) scores at 24 h compared to placebo and had lower 24-h Pain Severity scores than H/A (p < 0.05). Treatments were generally well tolerated, with no significant difference in the frequency of patient-reported adverse events between groups. CONCLUSIONS:Rofecoxib 50 mg did not provide significantly different pain relief than placebo at 6 h, and the primary endpoint TOPAR was not attained, although it did show several efficacy benefits at 24 h, including a significant opioid-sparing effect. All treatments were well tolerated, with no significant differences observed. The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model.
RCT Entities:
OBJECTIVE: 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), rofecoxibpatients used significantly less rescue analgesia (p < 0.001) over 24 h. Rofecoxib also provided better Brief Pain Inventory Severity (p = 0.008) and Interference Domain (p = 0.045) scores at 24 h compared to placebo and had lower 24-h Pain Severity scores than H/A (p < 0.05). Treatments were generally well tolerated, with no significant difference in the frequency of patient-reported adverse events between groups. CONCLUSIONS:Rofecoxib 50 mg did not provide significantly different pain relief than placebo at 6 h, and the primary endpoint TOPAR was not attained, although it did show several efficacy benefits at 24 h, including a significant opioid-sparing effect. All treatments were well tolerated, with no significant differences observed. The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model.