An Open-label Pilot Comparison Between Alfentanil and Diamorphine for Palliative Care Patients Who Require Subcutaneous Opioids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change in MDAS will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
研究概览
简要总结
OBJECTIVES:
How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in the palliative care setting?
STUDY DESIGN:
An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaneous opioids.
详细描述
STUDY DESIGN
Study 1 - Open Label Pilot Day - 1 Hospice in-patients who are thought by a clinician to need subcutaneous strong opioids will be asked if they wish to take part in the study.
They will be given a patient information leaflet and a 'cooling off period' (a minimum of 1 day) to think about it. If the clinician feels that strong parenteral opioids are needed diamorphine will be commenced immediately (as standard practice).
Day 0 If the patient agrees to take part in the trial they will be asked to complete a consent form and this will be stored with the patient's notes.
The following assessments will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •To be thought by a hospice doctor to require parenteral strong opioids.
- •To have an estimated prognosis of less than 1 year.
排除标准
- •Inability to read English sufficiently to be able to complete assessment questionnaires.
- •Confusion sufficient so that patient is unable to complete questionnaires.
- •Weakness or fatigue sufficient so that patient is unable to complete questionnaires.
- •Radiotherapy to source of pain in last 4 weeks.
- •Change in corticosteroid dose in last week.
研究组 & 干预措施
Alfentanil
Hospice in-patients who require subcutaneous strong opioid administration will be given alfentanil
干预措施: Alfentanil (Drug)
Diamorphine
Hospice in-patients who require strong opioids will be given diamorphine
干预措施: Diamorphine (Drug)
结局指标
主要结局
The change in MDAS will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
时间窗: day 3
次要结局
- The change in BPI-SF(Day 7)
- The change in nausea visual analogue scale(Day 3)
- Change in nausea visual analogue scale(Day 7)
- The change in the BPI-SF(Day 3)
- Change in the number of vomits(Day 7)
- Change in the total dosage of breakthrough medication (number of doses x dosage)(Day 7)
- Change in MDAS between Days 0 and 7(Day 7)
- The difference in proportion of patients taking laxatives(Day 7)
研究者
Paul Perkins
Chief Investigator
Gloucestershire Hospitals NHS Foundation Trust