Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- total duration of treatment in days with strong opioids from day of inclusion
研究概览
简要总结
The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient hospitalized in the rheumatology department
- •Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology
- •Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion
排除标准
- •Patient with cancer or fibromyalgia already diagnosed at inclusion
- •Patient with poor French language skills
- •Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion
- •Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment
- •Patient already included in the study
研究组 & 干预措施
interventional group
benefiting from a multi-professional intervention around the strong opioid treatment with the aim of setting up a personalized pharmaceutical plan
干预措施: personalized pharmaceutical plan (Other)
control group
routine management, including medication reconciliation at entry and exit and pharmaceutical analysis of prescriptions
结局指标
主要结局
total duration of treatment in days with strong opioids from day of inclusion
时间窗: 6 months
次要结局
- pain assessment (numerical scale) at first patient call after stopping strong opioids(6 months)
- number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months)(3 months)
- number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days)(28 days)