Efficacy of Tramadol Hcl in the Treatment of Renal Colic
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
研究概览
简要总结
The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.
详细描述
Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical diagnosis of acute renal colic (Stage I)
- •Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II)
排除标准
- •Patients with known hypersensitivity to the study drugs
- •Pregnancy or lactation
- •Known renal failure or hepatic disease
- •Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)
结局指标
主要结局
Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
时间窗: 30, 60, 120 minutes
Need for rescue medication at 30 minutes (Stage I)
时间窗: 30 minutes
Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
时间窗: 24 and 48 hrs
次要结局
未报告次要终点