A multicenter, randomized, double-blind, placebo-controlled, double-dummy, parallel-group study was carried out to investigate the efficacy and tolerability of nimesulide in alleviating postoperative pain after orthopedic knee surgery in comparison with naproxen and placebo.
In patients undergoing arthroscopic knee
surgery, nimesulide is an effective, fast-acting agent with a better analgesic
effect compared to naproxen. It was found to be well-tolerated with no
gastrointestinal side effects.
A
multicenter, randomized, double-blind, placebo-controlled, double-dummy,
parallel-group study was carried out to investigate the efficacy and
tolerability of nimesulide in alleviating postoperative pain after orthopedic
knee surgery in comparison with naproxen and placebo.
The
study recruited 94 patients having at least moderate postoperative pain after
meniscectomy and arthroscopy. Participants were randomly assigned to receive
100 mg nimesulide twice daily (n = 29), 500 mg naproxen twice daily (n = 34),
or placebo (n=31) for a maximum of three days. Utilizing a 5-point verbal scale
and a 100 mm visual analog scale (VAS), the pain intensity was determined. The
summed pain intensity difference (SPID) within 6 hours after the first
treatment was the primary endpoint.
Compared to placebo, nimesulide showed superior efficacy for combating postoperative pain within the first six hours of treatment (mean SPID: 10.91 for nimesulide and 6.29 for placebo). Nimesulide was considerably more effective than naproxen and placebo in minimizing pain intensity as shown in the following figure:
Fig: Mean SPID for the 0 to 6 hour period after first intake of study medications. Each bar depicts means+Standard Deviation
For the secondary efficacy variables, nimesulide depicted a better analgesic effect in comparison with placebo and naproxen. All three therapies were found to be well-tolerated, with only a few patients witnessing adverse effects in the nimesulide group.
No gastrointestinal adverse effects were reported in patients treated with nimesulide. The treatment-emergent gastrointestinal adverse events are summarized in the table below:
Table:
Nimesulide is an effective,
fast-acting and well-tolerated oral anti-inflammatory drug with a distinct
analgesic activity after out-patient orthopedic surgery.
The Clinical Journal of Pain
Nimesulide in the treatment of postoperative pain: a double-blind, comparative study in patients undergoing arthroscopic knee surgery
Alexander Binning
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