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临床试验/NCT01374763
NCT01374763已完成4 期

A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

Kati Järvelä1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Drug: prolonged-release oxycodone

干预措施: Oxycodone (Drug)

Oxycodone/naloxone

Active Comparator

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

发起方
Kati Järvelä
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kati Järvelä

MD, PhD

Tampere University Hospital

研究点 (1)

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