A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Duration of opioid-induced bowel dysfunction postoperatively
研究概览
简要总结
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.
详细描述
Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult cardiac surgery patient
排除标准
- •Preoperative continuous use of laxatives
- •Known anatomic or functional gastrointestinal disorder
研究组 & 干预措施
Oxycodone
Drug: prolonged-release oxycodone
干预措施: Oxycodone (Drug)
Oxycodone/naloxone
Prolonged-release oxycodone/naloxone
干预措施: Prolonged-release oxycodone/naloxone (Drug)
结局指标
主要结局
Duration of opioid-induced bowel dysfunction postoperatively
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
次要结局
- Need of laxatives postoperatively(Participants will be followed for the duration of hospital stay, an expected average of 5 days)
研究者
Kati Järvelä
MD, PhD
Tampere University Hospital
