Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Department (ED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- analgisia effect of acupuncture
研究概览
简要总结
Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED.
In 1998, a United States National Institute of Health Consensus Conference Panel reviewed the status of acupuncture and concluded that: "There is sufficient evidence of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value." Similarly, in 2002, the World Health Organisation (WHO) stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness as analgesia has been established in controlled clinical studies.
Notwithstanding these difficulties, it has been shown that acupuncture analgesia in the treatment of chronic pain is comparable to morphine and that its better safety profile and lack of dependence makes it the preferred method of choice for these conditions.
There are very few clinical trials of acupuncture for acute pain to inform clinical practice; that's why we have the idea to do this study in our emergency department.
详细描述
The objective is to evaluate the efficacy and the tolerance of acupuncture compared to intravenous morphine in the management of acute pain.
The results will also identify the impact that acupuncture treatment may have upon health resource utilization in the ED setting.
It is a randomized, prospective, controlled, conducted into emergency department. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).
In all included we recorded at baseline :
Age, sex, job, comorbidity, hour of beginning of pain. Injury nature and severity assessed by the Injury Severity Score (ISS) Mechanism of the injury and radiologic findings. VAPS : 0-100%
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
- •Traumatic and non traumatic acute (<72 hours) musculoskeletal pain with visual analog pain scale ( VAS or NRS ) > 40 (on a scale 0-100)
- •Age ≥18 years
- •Presigned consentement to participate in the study.
- •no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity); shoulder and elbow tendonitis; upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit; acute abdominal pain with no urgent surgical intervention including renal colic and dysmenorrhea; and acute headache .
排除标准
- •Temperature > 37.7° C,
- •Anticoagulation medication use or the presence of a mechanical heart valve,
- •Skin infections that would preclude certain acupuncture points being used,
- •Refusal, inability to consent or communication difficulties,
- •Acute major trauma,
- •Any form of analgesia up to 60 minutes prior to study start,
- •An initial pain score ≤ 40 on the pain scale (score range 0-100),
- •Opiate contraindication,
- •Pregnancy,
- •Presentation to the ED > 4 times in the previous 3 months with the same condition.
结局指标
主要结局
analgisia effect of acupuncture
时间窗: one year
subjuctive outcome
次要结局
- use of acupuncture in emergency departement(one year)
研究者
Pr. Semir Nouira
professor
University of Monastir