Preemptive QP001 provides analgesia and reduces opioid consumption in subjects with moderate to severe pain following abdominal surgery: a randomized controlled trial

Abstract

Abstract Background QP001, a novel meloxicam formulation, has been developed to manage moderate to severe postoperative pain. This study aimed to evaluate the efficacy and safety of QP001 injections for moderate to severe pain following abdominal surgery. Method This prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial enlisted patients experiencing moderate to severe pain following abdominal surgery. These patients were randomized to receive either QP001 injections (30mg or 60mg) or a placebo pre-surgery. The primary efficacy endpoint was the total morphine consumption within 24 hours after the first administration. Results A total of 108 patients were enrolled, and 106 patients completed the study. The total morphine consumption in the QP001 30mg group and 60mg group were significantly lower than that in the placebo group within 24 hours after the first administration (mean [SD] 5.11[5.46] vs 8.86[7.67], P = 0.011; 3.11[3.08] vs 8.86[7.67], P < 0.001). Compared with the placebo group, the total morphine consumption in the QP001 30mg and 60mg groups significantly decreased within 48 hours and 24–48 hours after the first administration (P ≤ 0.001); the area under curve of pain intensity-time and the effective pressing times of analgesic pump within 24 h and 48 h after the first administration was significantly reduced (P < 0.05). The QP001 groups did not show more Adverse Events and Adverse Drug Reactions than the placebo group(P > 0.05). Conclusion Preemptive QP001 provides analgesia and reduces opioid consumption in subjects with moderate to severe pain following abdominal surgery, while maintaining a favorable safety profile.