Cognitive Study on the Use of Central Analgesic Drugs in the Management of Chronic Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- adherence to therapy
研究概览
简要总结
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain .
However, pain management is mostly inadequate. This study aims to assess the Italian clinical practice in reference to the pharmacological management of chronic pain by health professionals involved in the treatment of pain in some centers belonging to the Italian network of pain therapy.
详细描述
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
In fact, the Ministry of Health, first in Europe, introduced a law in 2010 (March 15, 2010, No. 38) to provide for the sick, cancer or not, easy access to the necessary care and to provide specialists a specific training course.
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain (Marcus 2011).
The "pain disease" is one of the most common causes of access to medical care so it should be recognized as a complex health and research problem, being one of the most expensive and investigated conditions in our society (Pizzo and Clark, 2012; Gupta et al. , 2010; Dagenais et al., 2008).
It has a significant impact on the subjective perception of health status, influence daily activities and is associated with symptoms of depression and other psychological problems that affect the quality of life of the patient (end of 2011 Gureje et al., 1998; Bair et al., 2003, Portenoy, 1996).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males and females over the age of 18 years
- •Chronic neuropathic and / or nociceptive and / or mixed pain, whereby clinicians considers necessary to start opioid therapy
- •Signed informed consent
排除标准
- •Males and females aged under 18 years
- •Patients already receiving opioid analgesic drugs or drugs of the class MOR-NRI.
- •Taking abuse drugs or alcohol abuse
- •Patients with contraindications to the use of central analgesic drugs
- •Patients who refuse participation
- •Prior cognitive impairment or mental retardation
- •Severe immunodeficiency (WBC <4,000)
- •Severe renal impairment (serum creatinine > 2g/dl or Creatinine clearance <30 ml / h)
- •Hepatic impairment (Cholinesterase <2.000UI or INR> 2)
结局指标
主要结局
adherence to therapy
时间窗: 18 months
to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment
次要结局
- adherence at 6 months(18 months)
- side effects(18 months)
- quality of life(18 months)
研究者
Christian Compagnone
MD
University of Parma