A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Proportion of participants with a 30% increase in total Brief Pain Inventory between day 0 and day 14 in the active drug group versus the placebo group.
研究概览
简要总结
National guidelines advocate the use of paracetamol in conjunction with strong opioids for cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the analgesic benefit of paracetamol in this large patient group. The investigators aim to establish if paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years and over
- •Under palliative care/oncology service review
- •Diagnosis of incurable cancer
- •Clinician-predicted life expectancy >2 months
- •Anticipated to be clinically stable for duration of study involvement
- •Receiving daily regular strong opioids
- •Able to take study drug/placebo in its current form
- •Prescribed and taking paracetamol 1g four times a day
- •Average pain >3 and <9 in past 24 hours
- •Able to provide written informed consent
- •Able to complete necessary assessments required as part of the trial
- •Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation
排除标准
- •Pain which the clinician deems to be unstable
- •Clinically significant renal or liver disease
- •Weight less than 50kg
- •Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
- •Co-enrolment in other drug trials
- •Known to be pregnant or breast-feeding at the time of recruitment
- •Previously enrolled in this study
研究组 & 干预措施
Paracetamol
Participants will take blinded Paracetamol (as they were taking before entering the study)
干预措施: Paracetamol (Drug)
Placebo
Participants will take blinded Paracetamol
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with a 30% increase in total Brief Pain Inventory between day 0 and day 14 in the active drug group versus the placebo group.
时间窗: 14 days
次要结局
未报告次要终点