Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain reduction caused by paracetamol 4g/d
研究概览
简要总结
Randomised, double-blind placebo controlled cross-over trial
Main goal:
Optimize the medical pain treatment for patients with advanced cancer disease
Study goal:
Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.
详细描述
National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.
Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.
Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.
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
- •Adults (> 18 years) of both sexes
- •Diagnosed with advanced cancer disease
- •Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily
- •NRS median pain score last 24 hrs > 4
- •Able to take tablets (paracetamol) orally
排除标准
- •Mental or physical deficiency precluding data collection.
- •Reduced liver function judged with bilirubin, INR and transaminases
- •Anticoagulation with warfarin
- •Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
- •Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.
研究组 & 干预措施
Placebo pills
Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
干预措施: placebo tablets (Drug)
oral paracetamol 4 g daily
Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
干预措施: paracetamol (Drug)
结局指标
主要结局
Pain reduction caused by paracetamol 4g/d
时间窗: Last day in each 3 days study period
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
次要结局
- Overall satisfaction with the pain treatment(End of each 3 days study period)