The Efficacy and Safety of Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy - a Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
研究概览
简要总结
The study was performed in patients aged 6-18 years after the Ravitch procedure and thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain control provided by the multimodal approach that involves the continuous infusion ropivacaine with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary aims were to identify the determinants of acute post-operative pain at rest, during deep breathing and coughing.
详细描述
The subjects were randomized to the Ropivacaine/Fentanyl (RF) or Bupivacaine/Fentanyl (BF) group.
To perform a thoracic surgical procedure, all patients were premedicated with midazolam, and then, paracetamol, non-steroidal anti-inflammatory drugs, fentanyl, propofol, pancuronium or rocuronium (in children < 10 years old) and suprane were used to introduce and maintain the anesthesia. Thoracic epidural catheters were placed following induction of anesthesia and endotracheal intubation.
Intraoperative analgesia was introduced by a single dose of lidocaine 2% (2 mg/kg). Then after 15 minutes, the patients from the RF group received ropivacaine 1% (1-3 mg/kg) and those from the BF group bupivacaine 0.5% (0.5-1 mg/kg). After 60 minutes 0.2% ropivacaine solution with fentanyl or 0.125% solution of bupivacaine with fentanyl was infused with the flow rate of 0.1 ml/kg/hr.
Depending on the allocation to the group, postoperative analgesia was continued either with 0.2% ropivacaine and fentanyl or 0.125% bupivacaine and fentanyl, based on the concentration and the flow rate described above. In addition, intravenous paracetamol was administered as standard every 6 hours (the maximum of 60 mg/kg daily) along with non steroidal anti-inflammatory drugs. In children > 14 years of age, ketoprofen was injected at the dose of 1 mg/kg (the maximum of 200 mg daily) and in younger children ibuprofen (orally or rectally, up to 30 mg/kg daily) every 8 hours. Metamizol was given as a "rescue drug" (20 mg/kg).
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective thoracic surgery (thoracotomy or Ravitch procedure);
- •Analgesia: continuous thoracic epidural analgesia.
排除标准
- •American Society of Anesthesiologists physical status >III;
- •History of chronic pain or preoperative opioid use;
- •Oncological treatment;
- •Impaired verbal communication;
- •Removal of epidural catheter <24 h postoperatively;
- •Lack of postoperative chest drainage.
研究组 & 干预措施
Ropivacaine/Fentanyl
干预措施: Ropivacaine/Fentanyl (Drug)
Bupivacaine/Fentanyl
干预措施: Bupivacaine/Fentanyl (Drug)
结局指标
主要结局
Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
时间窗: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
时间窗: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
时间窗: postoperative day: 0-3
Side Effect Occurrence
时间窗: first 3 days after surgery
次要结局
- Patient satisfaction(postoperative day 3)
- Total fentanyl consumption [µg](postoperative day: 0-3)
- The number of doses of metamizol as a "rescue drug"(postoperative day: 0-3)
- The number of nursing interventions undertaken to relive pain > 2/10 pts(postoperative day: 0-3)
研究者
Lucyna Tomaszek, PhD, RN
Director of Nursing, Specialist Nurse in Anesthesia and Intensive Care
National Institute for Tuberculosis and Lung Diseases, Poland