Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Time of Stone Passage
研究概览
简要总结
Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.
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
- Double (Participant, Care Provider)
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 y.o. or older
- •diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
- •physician has made the decision that you will be discharged to home
- •must be able to take study medication for up to 10 days and strain your urine
- •must be able to keep a record of pain medication taken and complete a pain scale rating
排除标准
- •patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
- •patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
- •patient known to have hypersensitivity to Tamsulosin
- •patient history of cataract surgery
- •inability of patient to perform visual pain scale
- •allergy or intolerance to acetaminophen/oxycodone
- •patient is unable to understand informed consent
- •prisoners
研究组 & 干预措施
Tamsulosin
干预措施: Flowmax (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Time of Stone Passage
时间窗: 10 Days
Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.
次要结局
未报告次要终点