Bektas Firat, Eken Cenker, Karadeniz Ozgur, Goksu Erkan, Cubuk Metin, Cete Yildiray
Department of Emergency Medicine, Akdeniz University Faculty of Medicine, Antalya, Turkey.
Ann Emerg Med. 2009 Oct;54(4):568-74. doi: 10.1016/j.annemergmed.2009.06.501. Epub 2009 Jul 31.
This randomized, placebo-controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol and morphine for the treatment of renal colic.
We conducted a randomized, double-blind, placebo-controlled clinical trial comparing single intravenous doses of paracetamol (1 g), morphine (0.1 mg/kg), and placebo (normal saline solution) for patients presenting to the emergency department (ED) with suspected renal colic. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain intensity 30 minutes after treatment among the 3 arms, as well as the need for rescue medication and the presence of adverse effects.
Six hundred forty-five consecutive patients were screened for study and 165 were entered. Eight subjects were subsequently excluded from analysis because of protocol violations and 11 were excluded because of uncertain diagnoses, leaving 146 subjects available for analysis. The mean reduction in visual analogue scale pain intensity scores at 30 minutes was 43 mm for paracetamol (95% confidence interval [CI] 35 to 51 mm), 40 mm for morphine (95% CI 29 to 52 mm), and 27 mm for placebo (95% CI 19 to 34 mm). Statistically significant mean differences in pain intensity reductions compared with those for placebo were observed for paracetamol (16; 95% CI 5 to 27; P=.005) and morphine (14; 95% CI 0.4 to 27; P=.05); however, no difference was found between paracetamol and morphine (2; 95% CI -13 to 16; P=.74). Rescue analgesics at 30 minutes were required by 21 subjects (45%) receiving paracetamol, 24 subjects (49%) receiving morphine, and 34 subjects (67%) receiving placebo (P=.08). At least 1 adverse effect was experienced by 11 (24%) receiving paracetamol, 16 (33%) receiving morphine, and 8 (16%) in the placebo group (P=.14). There were no serious adverse events.
Intravenous paracetamol is an efficacious and safe treatment for ED patients with renal colic.
本随机、安慰剂对照试验评估静脉注射单剂量对乙酰氨基酚和吗啡治疗肾绞痛的镇痛效果及安全性。
我们进行了一项随机、双盲、安慰剂对照临床试验，比较静脉注射单剂量对乙酰氨基酚（1克）、吗啡（0.1毫克/千克）和安慰剂（生理盐水溶液）对疑似肾绞痛而就诊于急诊科（ED）的患者的疗效。30分钟时疼痛缓解不充分的受试者接受挽救性芬太尼（0.75微克/千克）治疗。我们比较了三组治疗30分钟后疼痛强度的变化，以及挽救性药物治疗的需求和不良反应的发生情况。
连续筛查645例患者进行研究，165例纳入研究。随后，8例受试者因违反方案被排除在分析之外，11例因诊断不明确被排除，最终146例受试者可供分析。对乙酰氨基酚组30分钟时视觉模拟评分疼痛强度平均降低43毫米（95%置信区间[CI]35至51毫米），吗啡组为降低40毫米（95%CI29至52毫米），安慰剂组为降低27毫米（95%CI19至34毫米）。与安慰剂组相比，对乙酰氨基酚组（16；95%CI5至27；P = 0.005）和吗啡组（14；95%CI0.4至27；P = 0.05）疼痛强度降低有统计学显著差异；然而，对乙酰氨基酚组和吗啡组之间无差异（2；95%CI - 13至16；P = 0.74）。接受对乙酰氨基酚治疗的21例受试者（45%）、接受吗啡治疗的24例受试者（49%）和接受安慰剂治疗的34例受试者（67%）在30分钟时需要挽救性镇痛药（P = 0.08）。接受对乙酰氨基酚治疗的11例受试者（24%）、接受吗啡治疗的16例受试者（33%）和安慰剂组的8例受试者（16%）至少经历了1次不良反应（P = 0.14）。无严重不良事件发生。
静脉注射对乙酰氨基酚对急诊科肾绞痛患者是一种有效且安全的治疗方法。
