The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MaineHealth
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Rate of spontaneous ureteral stone expulsion
研究概览
简要总结
The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.
详细描述
This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •able to read, write, and speak English;
- •able to use the NRS pain scale; and
- •computed tomography diagnosed single lower ureteral calculus
排除标准
- •allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]);
- •sulfa/sulfonamide allergy;
- •inability to provide informed consent;
- •lithiasis of the ureteral intramural tract;
- •acute or chronic renal failure;
- •presence of multiple ureteral stones;
- •peptic ulcer disease;
- •liver failure;
- •concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
- •pregnancy;
- •breastfeeding; or
- •a history of urinary surgery or endoscopic treatment.
研究组 & 干预措施
I
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
干预措施: tamsulosin (Drug)
II
Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
干预措施: Standard therapy with ibuprofen and oxycodone. (Drug)
结局指标
主要结局
Rate of spontaneous ureteral stone expulsion
时间窗: 48, 120, 336 hours
次要结局
- Time to spontaneous ureteral stone expulsion.(48, 120, 336 hours)
- Self-reported NRS-11 pain scores.(48, 120, 336 hours)
- Number of colicky pain episodes.(48, 120, 336 hours)
- Number of days missed work or usual functional ability.(48, 120, 336 hours)
- Adverse medication-related events.(48, 120, 336 hours)
- Number of return ED visits or unscheduled PCP visits for continued pain.(48, 120, 336 hours)
- Amount of narcotic pain medication used.(48, 120, 336 hours)