EUCTR2021-003427-14-NO进行中（未招募）1 期
A randomized controlled trial of subcutaneous versus intravenous morphine when switching from oral to parenteral route in palliative cancer patients
Akershus University Hospital0 个研究点目标入组 60 人开始时间: 2021年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
- •Unsatisfactory pain control despite titration of oral or transdermal opioids
- •Planned discharge to home or nursing home
- •The physician considers the appropriate starting dose to be either morphine 5 mg/ml with infusion rate 0.3 to 0.8 ml/h or morphine 10 mg/ml with infusion rate 0.3 to 0.8 ml/h.
- •Signed informed consent from the patient
- •Patient available for admission to Department of Palliative Medicine in time to start infusion between 9 am and 1 pm (Monday-Wednesday
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •A clear indication for either intravenous or subcutaneous administration (by consensus of two senior consultants in palliative medicine)
- •Patient unable to report patient reported outcomes needed in the study due to language barriers, cognitive impairment, or delirium.
- •Impossible to establish venous access
- •Allergy or previous serious adverse effects from morphine
- •Opioid treatments other than oral/parenteral morphine, oral/parenteral oxycodone and transdermal/transmucosal fentanyl.
- •Contraindications to use of morphine.
- •- Severe renal failure (estimated glomerular filtration rate < 30 based on kreatinin)
- •Strong indication for start of morphine infusion outside of the time interval of 9 am to 1 pm Monday to Wednesday.
- •Estimated survival time <2 weeks based on clinical judgement (by consensus of two senior consultants in palliative medicine)
- •Severe cachecia or peripheral edemas which are relative contraindications to the subcutaneous route of administration (clinical judgement by the responsible physician)
- •Patients with Hb <9 g/dL (7.0 – 9.9 g/dL is considered moderate anemia) will not be included in the pharmacokinetic analyses because it can not be ruled out that the loss of 100-150 ml blood might be harmful in some of these patients.
研究者
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