International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- pain measurement with visual analogue scale
研究概览
简要总结
In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 year
- •OMS between 0 to 3
- •Patient who has to undergo an invasive gesture or a painful care
- •Absence of contra-indication to the administration of the product
排除标准
- •Patient already included in another incompatible study with this protocol
- •Patient incapable of self-assessment by the EVA
- •Confusional syndrome
- •Patient already included in this protocol
- •Exclusion criteria linked to the product
研究组 & 干预措施
A
50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar)
干预措施: 50% Oxygen/50% Nitrous oxide premix (Kalinox 170 bar) (Drug)
B
50% oxygen/50% Nitrogen premix
干预措施: 50% Oxygen/50% Nitrogen premix (Drug)
结局指标
主要结局
pain measurement with visual analogue scale
时间窗: EVA
次要结局
- feasibility of the kalinox 170 bar in invasives gestures in oncology(opinion of the patent and the caregiver)
- surveillance of the appearance of secondary effects(examination by the investigator)