A multiple-day regimen of parecoxib sodium 20 mg twice daily provides pain relief after total hip arthroplasty

BACKGROUND: This multicenter, multiple-dose, randomized, double-blind, parallel-group study compared the analgesic efficacy and safety of two dosing regimens of parecoxib sodium (parecoxib) versus placebo after total hip arthroplasty. METHODS: On study Day 1, 490 patients received a postoperative initial loading dose of IV parecoxib 40 mg, followed by a re-dose of parecoxib 20 mg in 484 of 490 patients. Subsequently, 479 randomized patients received double-blind treatment with parecoxib 20 mg bid (n = 159), parecoxib 20 mg qd (n = 159) followed by placebo, or placebo (n = 161) on Day 2. RESULTS: Patients treated with parecoxib 20 mg bid reported significantly lower summed pain intensity over 24 h (SPI-24) scores and improved patients' global evaluation of study medication (PGESM) ratings compared with placebo-treated patients on Days 2 to 5 (P < 0.05). For patients treated with parecoxib 20 mg qd, SPI-24 scores were significantly lower on Days 3 and 4 (P < 0.05), and PGESM ratings significantly improved on Day 5 compared with placebo. The incidence of adverse events was similar in all treatment groups with the exception of fever, vomiting and impaired concentration, which were significantly more common in the placebo group compared with one or other of the parecoxib treatment groups (P < 0.05). CONCLUSION: Multiple-day administration of parecoxib 20 mg once or twice daily is effective and generally well tolerated after total hip arthroplasty.