Yaowalaorng Jarupa, Kunthasook Wiracha, Lokeskrawee Thanin, Patumanond Jayanton, Wongyikul Pakpoom, Lawanaskol Suppachai, Udornpim Narada
Department of Emergency Medicine, Lampang Hospital, Lampang, Thailand.
Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Emerg Med Australas. 2025 Feb;37(1):e14550. doi: 10.1111/1742-6723.14550.
The present study aimed to compare time to effective pain relief between diclofenac 75 mg intramuscular (IM) and tramadol 50 mg intravenous (IV) for ED patients with acute renal colic.
A randomised, double-blinded, sham-controlled, superiority trial was conducted. Patients diagnosed with acute renal colic (hydronephrosis and/or stone visualisation on point-of-care ultrasound) in the ED were randomly assigned to receive an IM injection of 75 mg of diclofenac or IV tramadol 50 mg. Pain relief was defined as a numerical rating scale reduction of two or more points (standard 0-10 scale) and a reduction of at least one level of pain transition question ('much better', 'little better', 'unchanged', 'little worse', 'much worse'). The primary outcome was the multivariable-adjusted subdistribution-hazard ratio (SHRs) within 120 min in the ED, estimated using the cumulative incidence function (CIF). The secondary outcome compared the average time to pain relief using the restricted mean survival time (RMST).
A total of 68 patients were randomised, with 34 patients allocated to each group. At the 120 min, pain relief was reported in diclofenac and tramadol, 32 (94%) and 22 (65%) patients respectively. SHR was 2.86 (95% CI: 1.80-4.55; P value <0.001). For diclofenac and tramadol, the RMSTs were 37.09 min (95% CI: 30.00, 44.15) and 78.74 min (95% CI: 66.49, 90.99) respectively, with the difference of 41.67 min (95% CI: 55.71, 27.62).
Diclofenac 75 mg IM provides faster effective pain relief compared with tramadol 50 mg IV.
本研究旨在比较双氯芬酸75毫克肌内注射（IM）和曲马多50毫克静脉注射（IV）对急诊科急性肾绞痛患者实现有效止痛的时间。
进行了一项随机、双盲、假对照的优效性试验。急诊科中被诊断为急性肾绞痛（即时超声检查显示肾积水和/或结石）的患者被随机分配接受75毫克双氯芬酸的肌内注射或50毫克曲马多的静脉注射。疼痛缓解定义为数字评分量表降低两分或更多分（标准0 - 10分制）以及疼痛转变问题的等级至少降低一级（“好多了”“稍好一点”“无变化”“稍差一点”“差得多”）。主要结局是急诊科120分钟内使用累积发病率函数（CIF）估计的多变量调整后亚分布风险比（SHRs）。次要结局使用受限平均生存时间（RMST）比较平均止痛时间。
共68例患者被随机分组，每组34例。在120分钟时，双氯芬酸组和曲马多组分别有32例（94%）和22例（65%）患者报告疼痛缓解。亚分布风险比为2.86（95%置信区间：1.80 - 4.55；P值<0.001）。双氯芬酸组和曲马多组的受限平均生存时间分别为37.09分钟（95%置信区间：30.00，44.15）和78.74分钟（95%置信区间：66.49，90.99），差值为41.67分钟（95%置信区间：55.71，27.62）。
与50毫克曲马多静脉注射相比，75毫克双氯芬酸肌内注射能更快实现有效止痛。
