The SIM-study: A Randomized Controlled Trial of Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time from initiation of i.v./s.c. morphine to stable infusion rate is reached
研究概览
简要总结
The investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.
Patients admitted to a Hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited.
The patients will have two similar infusion pumps with continuous infusion and bolus function. One infusion pump will be connected to an intravenous line, the other to a subcutaneous line. One pump contains morphine, one placebo. The primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached.
详细描述
Intravenous administration has theoretical advantages in more predictable pharmacokinetics and shorter time to maximum effect. Subcutaneous administration is less invasive, requires less specialized personnel and equipment, and probably poses a lower risk of complications than an intravenous line. Traditionally the subcutaneous route has been the recommended first choice for parenteral administration of opioids for palliative cancer patients.
The investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.
Patients admitted to a Hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited.
The patients will have two similar infusion pumps with continuous infusion and bolus function. One infusion pump will be connected to an intravenous line, the other to a subcutaneous line. One pump contains morphine, one placebo. The primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached. Secondary endpoints are time from bolus administration to pain relief, comparison of Tmax, Cmax, and size of AUC0-60 after bolus doses, the number of bolus doses first 24 and 48 hours, and the number of patients reaching acceptable pain relief within 48 hours.
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
- 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
- •Unsatisfactory pain control despite titration of oral or transdermal opioids
- •Planned discharge to home or nursing home
排除标准
- •Estimated survival time <2 weeks
- •A clear indication for either intravenous or subcutaneous administration
- •Patient unable to report patient reported outcomes needed in the study due to language barriers or cognitive impairment
- •Impossible to establish venous access
研究组 & 干预措施
Intravenous morphine infusion
Morphine 10 mg/ml or morphine 20 mg/ml will be diluted with normal saline to 5 mg/ml or 10 mg/ml. Both active study medication and placebo will be prepared in 100 ml drug containers suitable for the infusion pump.
The patient will have two similar infusion pumps. Morphine infusion connected to an i.v. line, placebo (normal saline) connected to a s.c line. Bolus dose will initially be equal to dose/hour. The nurse will administer bolus doses on both pumps (placebo and morphine pump) simultaneously. Patient reported pain intensity (NRS 0-10) and whether the bolus dose was initiated by the patient or the nurse will be recorded before each bolus dose. Bolus dose will be equally increased if/when the infusion rate is increased. If the bolus dose is ineffective, the bolus dose can be increased in steps of 0.1 ml until an effective dose is reached.
干预措施: Morphine (Drug)
Subcutaneous morphine infusion
Morphine 10mg/ml or morphine 20 mg/ml will be diluted with normal saline to 5 mg/ml or 10 mg/ml. Both active study medication and placebo will be prepared in 100 ml drug containers suitable for the infusion pump.
The patient will have two similar infusion pumps. Morphine infusion connected to a s.c. line, placebo (normal saline) connected to a i.v. line. Bolus dose will initially be equal to dose/hour. The nurse will administer bolus doses on both pumps (placebo and morphine pump) simultaneously. Patient reported pain intensity (NRS 0-10) and whether the bolus dose was initiated by the patient or the nurse will be recorded before each bolus dose. Bolus dose will be equally increased if/when the infusion rate is increased. If the bolus dose is ineffective, the bolus dose can be increased in steps of 0.1 ml until an effective dose is reached.
干预措施: Morphine (Drug)
结局指标
主要结局
Time from initiation of i.v./s.c. morphine to stable infusion rate is reached
时间窗: 48 hours
Time from initiation of i.v./s.c. morphine to stable infusion rate is reached
次要结局
- Time from bolus administration to clinically significant pain relief(60 minutes)
- Number of patients not reaching adequate pain relief.(48 hours)
- Number of bolus doses first 24 hours and 48 hours(24 and 48 hours)
- Time to maximum plasma concentration (Tmax).(120 minutes)
- Maximum plasma concentration (Cmax).(120 minutes)
- Area under the plasma concentration versus time curve (AUC).(120 minutes)
研究者
Olav Fredheim
Professor
University Hospital, Akershus