Efficacy of Caffeine as an Adjuvant to Opioid Therapy in Cancer Pain: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
研究概览
简要总结
Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.
详细描述
Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced (Stage IV) cancer inpatients
- •Adults aged over 18 years
- •Patients who have received opioid therapy and whose pain scales are under 6 (by numeric rating scale)
- •Patients who do not take caffeine beverage 48 hours before study period
- •Volunteers who provided written informed consent
排除标准
- •Sensitivity (palpitation,headache,irritability,insomnia) to caffeine
- •Uncontrolled hypertension and/or heart disease
- •Liver failure (alanine aminotransferase >= 100 IU/L)
- •Kidney failure (serum creatinine >= 2.0 mg/dL)
- •Patients taken theophylline
- •Gastroesophageal reflux disease
- •Chronic glaucoma
- •Cognitive impairment
- •Progressive pain over 7 (by numeric rating scale)
研究组 & 干预措施
Caffeine
Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
干预措施: Caffeine (Drug)
Placebo
Intravenous injections of 100ml of normal saline over 1 hour
干预措施: Normal saline (Drug)
结局指标
主要结局
Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids
时间窗: two days
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.
Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids
时间窗: two days
Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.
次要结局
- Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10(two days)
- Health-related Quality of Life(two days)
- Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)(two days)