NCT00224692终止3 期
MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine
详细描述
Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful mucositis
- •Child from 5 to 18 years.
- •Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic.
- •A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h).
- •Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA.
- •First morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of Ketamine/placebo (EVA > 30 after stop morphine).
- •Assent signed by the parents and each time possible by the child.
排除标准
- •The child was already included in the study.
- •The age of psychomotor development is lower than 5 years
- •Presence of a depression or a major depressive episode according to definition DSM IV.
- •Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
- •Bilirubin>3N
- •Gamma WP>3N
- •SGOT or SGPT >5N
- •Creatinin>3N
结局指标
主要结局
Pain score
次要结局
未报告次要终点
研究者
研究点 (2)
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