METHODS: Adults with CIBP and worst pain intensity ≥ 4/10 and/or opioid toxicity graded ≥ 2 on the Common Terminology Criteria for Adverse Events were randomised 1:1 to methadone or another opioid rotation. Standardised assessment tools were used at pre-defined study time points up to 14 days.
RESULTS: Of 51 eligible participants, 38 (74.5%) consented, and 29 (76.3%, MR: 14, OOR: 15) completed the fourteen days follow-up post-opioid rotation. Both groups displayed significant reduction in average (MR: d = - 1.2, p = 0.003, OOR: d = - 0.8, p = 0.015) and worst pain (MR: d = - 0.9, p = 0.042, OOR: d = - 0.6, p = 0.048) and total pain interference score (MR: d = - 1.1, p = 0.042, OOR: d = - 0.7, p = 0.007). Oral morphine equivalent daily dose was reduced significantly in MR compared to the OOR group (d = - 0.8, p = 0.05). The incidence of opioid-related adverse events following MR was unchanged but lower in the OOR group (d = 0.9, 95% CI 0.1,1.7, p = 0.022). There were no within-group or between-group differences in satisfaction with analgesia at the end of the study.
CONCLUSIONS: This pilot study demonstrated that MR and OOR in patients with refractory CIBP are feasible, safe and acceptable to patients. Appropriately powered multi-centre randomised controlled studies are needed to confirm the efficacy of MR and OOR in this cohort.
BACKGROUND: ACTRN12621000141842 registered 11 February 2021.
方法:在不良事件通用术语标准中,CI血压和最严重疼痛强度≥4/10和/或阿片类药物毒性分级≥2的成年人以1:1随机分配给美沙酮或另一种阿片类药物轮换。在长达14天的预定义研究时间点使用标准化评估工具。
结果:在51名符合条件的参与者中,38(74.5%)同意,和29(76.3%,MR:14,OOR:15)完成了阿片类药物旋转后14天的随访。两组均显示平均疼痛(MR:d=-1.2,p=0.003,OOR:d=-0.8,p=0.015)和最严重的疼痛(MR:d=-0.9,p=0.042,OOR:d=-0.6,p=0.048)和总疼痛干扰评分(MR:d=-1.1,p=0.042,OOR:d=-0.7,p=0.007)。与OOR组相比,MR中的口服吗啡等效日剂量显着减少(d=-0.8,p=0.05)。OOR组MR后阿片类药物相关不良事件的发生率没有变化,但较低(d=0.9,95%CI0.1,1.7,p=0.022)。在研究结束时,对镇痛的满意度没有组内或组间差异。
结论:这项初步研究表明,难治性CIBP患者的MR和OOR是可行的,患者安全且可接受。需要适当的多中心随机对照研究来确认该队列中MR和OOR的疗效。
背景:ACTRN12621000141842注册于2021年2月11日。