A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain

Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069.


Objective: The relative efficacy of rofecoxib, diclofenac sodium, and placebo were compared in the treatment of acute pain after bunionectomy surgery.

Research design and methods: This was a double-blind, randomized, two-part study of 252 patients with moderate-to-severe pain the day after first metatarsal bunionectomy. Patients were treated with a single dose of rofecoxib 50 mg (N = 85), enteric-coated diclofenac sodium 100 mg (N = 85), or placebo (N = 82) on study Day 1 (Part I), and subsequently with daily rofecoxib 50 mg or placebo (diclofenac patients switched to placebo) over study Days 2-5 (Part II). Patients rated their pain at 16 time points over the first 24 h. Primary endpoint was total pain relief over 8 h (TOPAR8). Pre-specified secondary endpoints on Day 1 included onset of analgesia, peak pain relief, and duration of response. For Part II, supplemental analgesia use with rofecoxib compared to placebo was pre-specified for analysis over Days 2-5, with the focus on Days 2-3. Adverse experiences were recorded over Days 1-5.

Results: For TOPAR8 scores, rofecoxib 50 mg was significantly more effective than placebo (9.5 vs. 3.7, p < 0.001) and diclofenac (9.5 vs. 5.0, p < 0.001). Onset of analgesia was more rapid with rofecoxib than placebo (p = 0.003) and diclofenac (p = 0.019); proportion of patients achieving onset within 4 h with rofecoxib, diclofenac, and placebo was 46%, 27%, and 23%, respectively. Peak pain relief was greater with rofecoxib (1.8) than diclofenac (1.2, p = 0.004) and placebo (1.0, p < 0.001). Diclofenac and placebo patients required supplemental analgesia sooner than rofecoxib patients (2:03 h vs. 4:02 h, p < 0.001 and 1:41 h vs. 4:02 h, p < 0.001). Rofecoxib patients used significantly less (p < 0.001) supplemental analgesia than placebo patients over Days 2-3 (1.1 tablets/day vs. 2.1 tablets/day) and Days 2-5 (0.9 tablets/day vs. 1.8 tablets/day). No significant differences in adverse experiences between treatments were seen.

Conclusion: Rofecoxib 50 mg was significantly more effective than placebo on all measures of treatment of post-bunionectomy pain. Rofecoxib 50 mg was significantly more effective than diclofenac sodium 100 mg based on Day 1 endpoints of total pain relief, onset time, and duration of response. All study medications were generally well tolerated.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Diclofenac / therapeutic use*
  • Double-Blind Method
  • Female
  • Hallux Valgus / surgery*
  • Humans
  • Lactones / therapeutic use*
  • Male
  • Middle Aged
  • Orthopedic Procedures / adverse effects*
  • Pain Measurement
  • Pain, Postoperative / drug therapy*
  • Placebos
  • Sulfones / therapeutic use*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Lactones
  • Placebos
  • Sulfones
  • rofecoxib
  • Diclofenac