Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
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 intensity difference (PID) at t=15 minutes
研究概览
简要总结
The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.
详细描述
Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate.
The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day
- •1-4 breakthrough pain episodes/day
- •Patients must be able, in the opinion of the investigator, to fully comply with trial requirements
- •Patients who have given written informed consent
排除标准
- •Uncontrolled pain
- •Women who are pregnant, lactating or intend to become pregnant
- •Cardiopulmonary disease that would increase the risk of opioids
- •Neurologic or psychiatric disease that would compromise data collection
- •Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain
结局指标
主要结局
Pain intensity difference (PID) at t=15 minutes
时间窗: t=15 minutes
次要结局
- PID 5'(5 min)
- PID 30'(30 min)
- PID 45'(45 min)
- PID 60'(60 minutes)
- time to onset of meaningful pain relief(time to onset)
- global efficacy rating at 60'(60 min)