The Safety and Efficacy of Epidural Oxycodone
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- amount of rescue medicine
研究概览
简要总结
There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.
In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.
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
- Double (Participant, Investigator)
盲法说明
similar syringes equal amount of drug
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned gynecological lower abdomen surgery with epidural pain treatment
- •Informed consent obtained
排除标准
- •Planned surgery under regional anesthesia
- •contraindication to the study drug
- •contraindication to the lumbar puncture
- •Contraindication to oxycodone
- •Pregnancy or lactation
- •no informed consent
研究组 & 干预措施
Oxycodone epidurally
Oxycodone 0,1 mg/kg epidurally
干预措施: Oxycodone intravenously (Drug)
Oxycodone intravenously
Oxycodone 0,1 mg/kg IV
干预措施: Oxycodone epidurally (Drug)
结局指标
主要结局
amount of rescue medicine
时间窗: from zero hours up to four hours
The amount of rescue pain medication given after study drug administration up to four hours
次要结局
未报告次要终点
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital