A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Reduce pain during bone marrow biopsy with aspiration.
研究概览
简要总结
Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.
Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler
详细描述
The efficacy of an inhaled equimolar mixture of nitrous oxide and oxygen to prevent procedural pain during lumbar puncture in children has been demonstrated. In adults the use of an inhaled equimolar mixture could prevent pain.
Although nitrous oxide was initially considered innocuous, evidence began to be gathered later that it had potentially side effect. It has been demonstrated that nitrous oxide inactivates the vitamin B12-dependent enzyme methionine synthetase and impairs DNA synthesis in bone marrow cells.
Therefore this prospective, multicenter randomized placebo controlled, double-blind trial was design to determine whether an inhaled equimolar mixture of nitrous oxide and oxygen would significantly reduce pain during bone marrow biopsy with aspiration. In addition we performed a careful cytological examination of bone marrow samples in order to evaluate the quality of the picture sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •with a good clinical condition (score ECOG < 2)
- •without contra indication for the use of nitrous oxide or previous medical history of allergy to Xylocaïne.
- •Informed consent signed up.
排除标准
- •pregnancy,
- •prior exposure to nitrous oxide,
- •patients with neurological illness and those on anti depressant medications or with congestive heart failure or significant respiratory disease.
- •patients on analgesia for other medical conditions or whose with the inability to provided consent of an assessment of pain.
- •patients with platelet dysfunction or related coagulation disorders, aspirin or warfarin therapy
结局指标
主要结局
Reduce pain during bone marrow biopsy with aspiration.
次要结局
- Evaluation of the quality of the picture sample
- Tolerability