NCT00181012Unknown3 期
Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old)
研究概览
简要总结
This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.
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
- Double
入排标准
- 年龄范围
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy
- •Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)
- •Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis
- •Pain resistant to morphinic treatment
排除标准
- •Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months
- •Neurological: non-controlled epilepsy, encephalopathy, or dementia
- •Severe hepatic insufficiency
- •Severe renal insufficiency
- •Respiratory insufficiency
- •Patients having surgery or in postoperative period
- •Known deficit in G6PD, alanine exposure, or sulphamide treatment
- •Porphyria
- •Weight > 80 kg
结局指标
主要结局
To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old)
时间窗: continuous intravenous perfusion for 6 days
次要结局
- To confirm the tolerance of the lidocaine
研究者
研究点 (2)
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