Women (N = 486) with moderate-to-severe
pain after open abdominal
hysterectomy were enrolled in this multicenter, randomized, double-blind, placebo- and active-controlled trial. Subjects were randomized to receive a single dose of
meloxicam IV (5-60 mg), placebo, or
morphine (0.15 mg/kg) in ≤6 hours after
morphine dosing on postoperative day 1 and were evaluated for 24 hours. Rescue
morphine (≈0.15 mg/kg IV) was available if needed for
pain not relieved by the study medication. In an open-label extension (N = 295),
meloxicam IV was administered once daily for the remaining
hospital stay (or per the investigator's discretion). The coprimary efficacy end points were the summed
pain intensity difference (SPID24) and total
pain relief (TOTPAR24) from hour 0 to 24 hours after dosing. Effect size, the standardized difference between means reported in standard deviation (SD) units, was calculated to indicate the magnitude of the difference in the mean
analgesic effect measured for different intervention groups.
RESULTS: Subjects who received
morphine or
meloxicam IV had a median time to first perceptible
pain relief within 6-8 minutes.
Morphine and
meloxicam IV 5-60 mg produced statistically significant differences than placebo in SPID24 and TOTPAR24. SPID24 (standard error [SE]) for
meloxicam IV 5-60 mg ranged from -56276.8 (3926.46) to -33517.1 (3930.1; P < .001); SPID24 (SE) for
morphine and placebo were -29615.8 (3869.2; P < .001) and 4555.9 (3807.1), respectively. SPID24 effect sizes (95% confidence intervals) for the 60, 30, 15, 7.5, and 5 mg
meloxicam IV doses and
morphine were 1.93 (1.61-2.25), 2.00 (1.65-2.35), 1.70 (1.35-2.05), 1.28 (0.95-1.60), 1.25 (0.90-1.61), and 1.12 (0.77-1.45) SDs, respectively. TOTPAR24 (SE) for
meloxicam IV 5-60 mg ranged from 3104.5 (155.28) to 4130.4 (191.17; P < .001); TOTPAR24 (SE) for
morphine and placebo were 2723.3 (188.4; P < .001) and 1100.6 (185.4), respectively. TOTPAR24 effect sizes (95% confidence interval) for the 60, 30, 15, 7.5, and 5 mg
meloxicam IV doses and
morphine were 2.03 (1.70-2.35), 2.05 (1.70-2.40), 1.78 (1.43-2.13), 1.35 (1.03-1.67), 1.37 (1.01-1.72), and 1.10 (0.75-1.45) SDs, respectively. The mean total
opioid consumed (SD) during the double-blind phase was 4.6 (8.17), 5.3 (8.85), 5.9 (7.85), 8.5 (9.67), 9.3 (9.47), 9.6 (8.12), and 16.0 (10.15) mg for patients in the 60, 30, 15, 7.5, and 5 mg
meloxicam IV,
morphine, and placebo groups, respectively. Generally,
meloxicam IV was well tolerated, evidenced by the incidence of adverse events compared to placebo and lack of deaths and treatment-related serious adverse events.
CONCLUSIONS: