This randomized, multicenter, double-blind, placebo-controlled trial evaluated
meloxicam IV 30 mg or placebo (≤ 3 doses) in 219 subjects undergoing
abdominoplasty. The primary endpoint was the summed
pain intensity difference over 24 hours postdose (SPID24).
RESULTS:
Meloxicam IV-treated subjects had a statistically significant reduction in the least squares mean of SPID24 compared with placebo-treated subjects (-4,262.1 versus -3,535.7; P = 0.0145).
Meloxicam IV was associated with statistically significant differences over placebo on several other secondary endpoints, including other SPID intervals (ie, SPID12, SPID48, and SPID24-48), achievement of perceptible
pain relief, the proportion of subjects with a ≥ 30% improvement in the first 24 hours, and Patient Global Assessment of
pain at hour 48.
Meloxicam IV was also associated with a reduction in the number of subjects receiving
opioid rescue medication during hours 24-48 and the total number of doses of
opioid rescue
analgesia.
Meloxicam IV was generally well tolerated, with the numbers and frequencies of adverse events similar to that of the placebo group. There was no evidence of an increased risk of adverse events commonly associated with nonsteroidal anti-inflammatory drugs including
bleeding, thrombotic, cardiovascular, renal, hepatic, cardiovascular, injection site, and wound healing events.
CONCLUSION: