Efficacy and safety of a single dose of IV parecoxib sodium followed by up to 7 days of oral valdecoxib for pain following laparoscopic cholecystectomy

Objectives

To assess the efficacy and safety of a single dose of parecoxib sodium 40 mg IV given 30–45 min preoperatively, followed by oral valdecoxib 40 mg every day for pain given for up to 7 days postsurgery.

Methods

This was a multicenter, randomized, double-blind, parallel-group trial. All patients received standard of care (SOC) fentanyl on demand for pain during the immediate postoperative period and acetaminophen 500 mg/hydrocodone 5 mg PO every 4–6 hours as required (for pain) following discharge for up to day 7 postsurgery. The active arm received, in addition, parecoxib sodium 40 mg IV administered 30–45 min preoperatively and valdecoxib 40 mg every day initiated 6–12 hours after surgery and continued up to day 7 postsurgery. The comparator arm received placebo (SOC) matched for the parecoxib sodium and valdecoxib. Pain was evaluated daily using the modified Brief Pain Inventory (mBPI) with 'Worst Pain' assessed using a 0–10 numerical rating scale (NRS) where 10 = worst pain imaginable.

Results

In the cohort (n = 223) during the immediate postoperative period (4 hours), the parecoxib sodium group (n = 119) required significantly lower amounts of fentanyl (152.8 μg vs 192.9 μg: P = 0.011) than the comparator group (n = 104). Significantly fewer patients in the valdecoxib group required supplemental analgesia over days 1–5 postsurgery (P < 0.02). 'Worst Pain' scores were also statistically significantly improved in the valdecoxib-treated group compared with placebo (SOC). Percent of patients reporting worst pain as none or mild (NRS ≤ 4) in the valdecoxib and placebo (SOC) group on day 1 was 63.1% vs 29.2% (P < 0.001); day 2 69.2% vs 56.0%. The most common adverse events were nausea, headache, constipation, pain, fatigue and diarrhea, which were comparable between groups.

Conclusions

Preoperative administration of parecoxib sodium 40 mg IV resulted in significant opioid sparing immediately following laparoscopic cholecystectomy surgery. Valdecoxib 40 mg every day provided significant opioid-sparing effects and reduced 'Worst Pain' levels in these patients following discharge. Both parecoxib sodium and valdecoxib were well tolerated.