NCT01546701已完成4 期
Buprenorphine in Acute Renal Colic Pain Management
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- change in pain score
研究概览
简要总结
The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.
排除标准
- •previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
- •febrile patients (T > 38°C);
- •hemodynamically unstable patients ( Systolic Blood Pressure < 90 mmHg);
- •pregnant patients;
- •patients with abdominal tenderness as a sign of peritoneal inflammation;
- •any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection;
- •patients with a history of drug addiction or known allergy to opioids;
- •patients who had used analgesics 6 hours before arriving.
研究组 & 干预措施
Buprenorphine
Experimental
Renal Colic Patients treated by 2 mg sublingual Buprenorphine.
干预措施: Buprenorphine (Drug)
Morphine
Active Comparator
Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.
干预措施: Morphine (Drug)
结局指标
主要结局
change in pain score
时间窗: 20 and 40 minutes
change in pain severity based on Numerical Rating Score
次要结局
- treatment side effects(40 minutes)
研究者
研究点 (1)
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