"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dyspnea on a VAS scale
研究概览
简要总结
The purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.
详细描述
Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time.
Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Primary lung cancer or lung metastases and
- •Moderate to severe dyspnea at rest (VAS equal to or more than 30)
排除标准
- •Causal treatment of dyspnea possible and indicated
- •Not receiving opioids on a regular basis
- •Methadone treatment
- •Intolerance to morphine
- •Without understanding of patient information
- •Depressed consciousness
- •Oxygen treatment, if changed with-in 20 min before start
- •Short-acting opioids with-in 4 h before start
- •Inhalation therapy for bronchodilation with-in 20 min before start
研究组 & 干预措施
1
干预措施: Morphine p.o. (Drug)
2
干预措施: Morphine s.c. (Drug)
结局指标
主要结局
Dyspnea on a VAS scale
时间窗: 1 hour
次要结局
- Respiratory rate, pulse rate, oxygen saturation(1 hour)