Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Pain score - Visual Analouge Scale
研究概览
简要总结
The aim of this randomized controlled study is to shed light on the analgesic properties and side-effect profile of an opiod-based regimen as opposed to an Ibuprofene based regimen.
详细描述
Background:
Postoperative pain following median sternotomy can represent a major postoperative problem as it can lead to reduced mobilization and shallow, restricted breathing and insufficient cough, which can lead to pulmonary complications.
However, pain management with opioids has frequent side-effects such as confusion, respiratory depression, sedation, nausea and obstipation/ paralytic ilieus. Non-steroid anti-inflammatory drugs (NSAIDs) can been used as opiod-sparing analgesics following cardiac surgery. However, this remains controversial, as NSAIDs has been linked to an increased risk of myocardial infarction, especially in patients with ischaemic heart disease, renal failure, gastrointestinal bleeding, and possibly impaired sternal healing.
The investigators wanted to investigate the analgesic properties of a opiod-based regimen with that of an ibuprofene-based, through randomization of patients to one of the two arms.
Intervention:
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
- 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
- •Cardiac surgery through median sternotomy
- •Written consent
- •Age over 18 years
排除标准
- •Other forms of sternotomy (i.e. re-sternotomy or partial sternotomy)
- •Preoperative creatinine over 110 µmol/L
- •Preoperative use of opioids or NSAIDs in analgesic doses (aspirin in antithrombotic doses was accepted)
- •Allergy to NSAIDs or opioids, and other contraindications to the used drugs
- •The postoperative exclusion criteria were:
- •Staying more than one night at the intensive care unit
- •Unacceptable side effects
- •Exclusion at the patients request
研究组 & 干预措施
Opioid group
If randomized to the opiod group, the patient was given the following regimen for 1 week, upon return from the intensive care unit, after surgery.
Tbl. Oxycodone (slow-release) 10mg, Twice daily for 1 week Tbl. Paracetamol 1000mg, Four times daily for 1 week Tbl.oxycodone 5mg Max 4 times daily, as needed, until discharge. Inj, oxycodone 2.5 mg, Max 4 times daily, as needed, until discharge Tbl. Magnesia 1g, Twice daily, for 1 week Sol. Sodiumpicosulfate 7.5mg/ml 10 drops daily, for 1 week
干预措施: Oxycodone (Drug)
Ibuprofene group
If randomized to the ibuprofen group, the patient was given the following regimen for 1 week, upon return from the intensive care unit, after surgery.
Tbl. Ibuprofen (slow-release) 800mg, Twice daily, for 1 week Tbl. Paracetamol 1000mg, Four times daily, for 1 week Tbl.oxycodone 5mg Max 4 times daily, as needed. Until discharge. Inj, oxycodone 2.5 mg Max 4 times daily, as needed. Until discharge. Tbl. Lanzoprazole 40 mg, Once daily, for 1 week Tbl. Magnesia 1g, Twice daily, for 1 week Sol. Sodiumpicosulfate 7.5mg/ml, 10 drops daily, for 1 week
干预措施: Ibuprofene (Drug)
结局指标
主要结局
Pain score - Visual Analouge Scale
时间窗: 5 days
Visual analouge scale from 0-10, recorded at noon every day. Given as average/minimum/maximum previous 24h by patient. Until discharge, average 5th postoperative day.
次要结局
- Nausea, Hours(5 days)
- Vomiting, events pr. 24 hours(5 days.)
- Myocardial Infarction, no. of cases(36 months)
- All cause mortality(36 months)
- Gastro-intestinal bleeding, no. of cases(36 months)
- Degree of mobilization, Mobilization scale(5 days)
- Bowel movement, hours until movement(5 days)
- Opioid antidote(5 days)
- Renal function as serum-creatinine (micromol/l)(36 months)
- Hallucination, events pr. 24 hours(5 days)
- Sternal non-union, no of cases(36 months)
- Confusion(5 days)
研究者
Martin Agge Nørgaard
MD, DMsc
Aalborg University Hospital