OBJECTIVE: To determine the analgesic efficacy of 1-day and multiple-day dosing regimens of parecoxib sodium (parecoxib) after bunionectomy in 2 randomized placebo-controlled studies. METHODS: The first double-blind study assessed the efficacy of intravenous parecoxib 40 mg followed by an additional dose of parecoxib 20 mg, parecoxib 40 mg followed by placebo, or 2 placebo doses over 1 day. In the second study, all patients received parecoxib 40 mg and a second dose of 20 mg on day 1. On days 2 and 3, patients were randomized to parecoxib 20 mg once daily and placebo once daily, parecoxib 20 mg twice daily, or placebo twice daily. Rescue medication (hydrocodone 5 mg/acetaminophen 500 mg) was available throughout both studies. RESULTS: In the single-day study, patients receiving parecoxib had significantly improved summed pain intensity difference through 24 hours, time-weighted sum of total pain relief through 24 hours, and Patient's Global Evaluation of Study Medication (PGESM) scores compared with those given placebo. In the multiday study, patients given parecoxib had significantly improved summed pain intensity through 24 hours and PGESM scores compared with patients receiving placebo. The incidence of adverse events was lower in the parecoxib groups than in the placebo group on days 2 and 3. CONCLUSIONS:Parecoxib treatment, in conjunction with supplemental analgesia given as needed, provided effective pain relief over 1 to 3 days in the bunionectomy model of postoperative analgesia. Bunionectomy is a useful model for testing multiple-day analgesic therapy.
RCT Entities:
OBJECTIVE: To determine the analgesic efficacy of 1-day and multiple-day dosing regimens of parecoxib sodium (parecoxib) after bunionectomy in 2 randomized placebo-controlled studies. METHODS: The first double-blind study assessed the efficacy of intravenous parecoxib 40 mg followed by an additional dose of parecoxib 20 mg, parecoxib 40 mg followed by placebo, or 2 placebo doses over 1 day. In the second study, all patients received parecoxib 40 mg and a second dose of 20 mg on day 1. On days 2 and 3, patients were randomized to parecoxib 20 mg once daily and placebo once daily, parecoxib 20 mg twice daily, or placebo twice daily. Rescue medication (hydrocodone 5 mg/acetaminophen 500 mg) was available throughout both studies. RESULTS: In the single-day study, patients receiving parecoxib had significantly improved summed pain intensity difference through 24 hours, time-weighted sum of total pain relief through 24 hours, and Patient's Global Evaluation of Study Medication (PGESM) scores compared with those given placebo. In the multiday study, patients given parecoxib had significantly improved summed pain intensity through 24 hours and PGESM scores compared with patients receiving placebo. The incidence of adverse events was lower in the parecoxib groups than in the placebo group on days 2 and 3. CONCLUSIONS:Parecoxib treatment, in conjunction with supplemental analgesia given as needed, provided effective pain relief over 1 to 3 days in the bunionectomy model of postoperative analgesia. Bunionectomy is a useful model for testing multiple-day analgesic therapy.
Authors: Ira J Gottlieb; Deborah R Tunick; Randall J Mack; Stewart W McCallum; Campbell P Howard; Alex Freyer; Wei Du Journal: J Pain Res Date: 2018-02-16 Impact factor: 3.133