STUDY OBJECTIVE We wished to determine whether the addition of magnesium sulfate (MgSO4) or lidocaine to diclofenac could improve the analgesic efficacy in emergency department (ED) patients with acute renal colic. METHODS In this prospective, double-blinded, randomized controlled trial of patients aged 18 to 65 years with suspected acute renal colic, we randomized them to receive 75 mg intramuscular (IM) diclofenac and then intravenous (IV) MgSO4, lidocaine, or saline solution control. Subjects reported their pain using a numerical rating scale (NRS) before drug administration and then 5, 10, 20, 30, 60, and 90 minutes afterwards. Our primary outcome was the proportion of participants achieving at least a 50% reduction in the NRS score 30 minutes after drug administration. RESULTS We enrolled 280 patients in each group. A 50% or greater reduction in the NRS score at 30 minutes occurred in 227 (81.7%) patients in the MgSO4 group, 204 (72.9%) in the lidocaine group, and 201 (71.8%) in the control group, with significant differences between MgSO4 and lidocaine (8.8%, 95% confidence interval [CI] [1.89 to 15.7], P=.013) and between MgSO4 and control (9.9%, 95% CI [2.95 to 16.84], P=.004). Despite this, differences between all groups at every time point were below the accepted 1.3 threshold for clinical importance. There were no observed differences between groups in the frequency of rescue analgesics and return visits to the ED for renal colic. There were more adverse events, although minor, in the MgSO4 group. CONCLUSION Adding intravenous MgSO4, but not lidocaine, to IM diclofenac offered superior pain relief but at levels below accepted thresholds for clinical importance.

中文翻译：

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硫酸镁与利多卡因作为急诊室肾绞痛的辅助药物：一项随机、双盲对照试验。


研究目的 我们希望确定双氯芬酸中添加硫酸镁 (MgSO4) 或利多卡因是否可以提高急诊 (ED) 急性肾绞痛患者的镇痛效果。方法 在这项针对 18 至 65 岁疑似急性肾绞痛患者的前瞻性、双盲、随机对照试验中，我们将他们随机分配接受 75 mg 肌肉注射 (IM) 双氯芬酸，然后静脉注射 (IV) MgSO4、利多卡因或盐水溶液控制。受试者在给药前以及给药后 5、10、20、30、60 和 90 分钟后使用数字评定量表 (NRS) 报告他们的疼痛。我们的主要结果是给药 30 分钟后 NRS 评分至少降低 50% 的参与者比例。结果 我们每组招募了 280 名患者。 30 分钟时，MgSO4 组有 227 例 (81.7%) 患者、利多卡因组有 204 例 (72.9%) 患者和对照组 201 例 (71.8%) 患者 NRS 评分下降 50% 或以上，差异显着MgSO4 和利多卡因之间（8.8%，95% 置信区间 [CI] [1.89 至 15.7]，P=.013）以及 MgSO4 和对照之间（9.9%，95% CI [2.95 至 16.84]，P=.004）。尽管如此，每个时间点所有组之间的差异均低于公认的临床重要性阈值 1.3。在抢救镇痛药和因肾绞痛而回急诊室就诊的频率方面，各组之间没有观察到差异。 MgSO4 组的不良事件较多，尽管较小。结论 在肌内注射双氯芬酸中添加静脉注射 MgSO4（而非利多卡因）可有效缓解疼痛，但其水平低于临床重要性可接受的阈值。