Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain score Change
研究概览
简要总结
The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.
详细描述
acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.
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
- •age > 18 years old
- •Presenting with acute non complicated renal colic
- •Baseline VAS score >/= 70
排除标准
- •complicated renal colic
- •VAS score < 70
- •Pain of traumatic origin
- •Coagulation abnormalities
- •Skin affections impairing the use of pre-specified insertion points
- •Enable to use the VAS
- •Patients who received analgesics less than 6 hours prior to enrollment
- •Patients refusing or enable to give written informed consent
- •Pregnant women
研究组 & 干预措施
Acupuncture
Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician.
干预措施: Traditional Acupuncture Session (Procedure)
Titrated Morphine
Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse.
干预措施: Morphine Titration (Drug)
结局指标
主要结局
Pain score Change
时间窗: at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention
Pain score is measured by a 100 millimeter visual analogue scale (VAS) and corresponds to the severity of the pain felt by the patient and varying from 0 (corresponding to no pain) to 100 (corresponding to the maximum imaginable pain).
次要结局
- Number of participants with treatment-related adverse events(during the 1 hour protocol and up to 2 hours after)
研究者
Pr. Semir Nouira
Clinical Professor
University of Monastir