Comparison of Two Antalgic Strategies: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Departement. A Randomized Trial of Efficacy and Safety
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- pain relief by VAS
研究概览
简要总结
Renal colics are a common cause af acute intense pain in medical emergency settings requiring often the use of high level antalgics (opioid) to relief the patient.
In the other hand, Acupuncture is well known widely for its therapeutic characteristics, especially in relieving pain.
the aim of these study is to compare this two pain relieving techniques in patients consulting the emergency departement (ED) for acute onset renal colics.
详细描述
acute onset pain is a frequent cause for consulting the ED (2/3 of patients). renal colics are a common cause for severe acute onset pain, we think approximatively 20% of patients consulting the ED for severe (VAS > 70) acute onset pain have renal colics (RC).
the guidelines for the treatment of severe RC recommend the association of two drugs: a nonsteroidal anti-inflammatory agent (NSAI) typically the Ketoprofen and an antalgic typically opioid (Morphine).
but this one face many critics regarding its safety and tolerance, that's why we investigated other pain relief strategies such as acupuncture.
acupuncture is one of the five branches of the traditional chinese medicine, it has proven its efficacity and safety in many conditions and in RC.
the aim of these study is to assess the feasibility, the safety, and the tolerance of an acupuncture pain-relief strategy compared to the conventional one (intravenous opioids) in the treatment of severe acute onset RC in emergency departement settings.
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
- 是
入选标准
- •age over 18 years
- •has a renal colic
- •VAS over 70
- •has not got another analgesic drug before coming to emergency departement
排除标准
- •age under 18 years
- •has not renal colic
- •VAS under 70
- •has got another analgesic treatment before coming to emergency departement
- •fever (T° > 38.5°c)
- •cutaneous infection in the punction sites
- •anuric patient
- •contre indication of morphine
研究组 & 干预措施
acupuncture group
The patient receives acupuncture session lasts between 20 to 30 minutes. Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA).
干预措施: acupuncture (Device)
Morphine group
Each patient must receive a bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement (VAS> 30).
干预措施: Morphine (Drug)
结局指标
主要结局
pain relief by VAS
时间窗: at baseline, 10, 20, 30, 45 and 60 minutes
the primary outcome is to assess the efficacity of acupuncture versus IV morphine expressed in VAS reduction during treatment. if there is a reduction of more than 50% of the baseline VAS, than the treatment is considered efficient.
次要结局
- side effects(during the 60 minutes of the treatment)
- number of patients completing the treatment(at baseline)
研究者
Pr. Semir Nouira
professor
University of Monastir