Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
研究概览
简要总结
The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of this trial is to determine whether the use of gabapentin as a component of multimodal analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The secondary objective of the trial are to evaluate whether the use of gabapentin reduces postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases side-effects, and improves patient satisfaction.
详细描述
The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively.
Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a "rescue drug"
The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •5 - 18 years of age;
- •surgery: lateral thoracotomy or Ravitch procedure;
- •postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.
排除标准
- •allergy or sensitivity to gabapentin;
- •history of chronic pain or daily analgesic use;
- •diagnosed with psychiatric disorders;
- •treated oncologically;
- •with impaired verbal communication;
- •the lack of postoperative chest drainage.
研究组 & 干预措施
Gabapentin
- Single dose preoperative gabapentin.
- After surgery gabapentin 2 times per day for 3 days.
干预措施: Gabapentin (Drug)
Placebo Control
- Single dose preoperative placebo control.
- After surgery placebo 2 times per day for 3 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
时间窗: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
时间窗: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
时间窗: postoperative day: 0-3
次要结局
- Total ropivacaine/fentanyl consumption.(postoperative day: 0-3)
- Side Effect Occurrence(first 3 days after surgery)
- Total morphine consumption.(postoperative day: 0-3)
- Patient satisfaction.(first 3 days after surgery)
- Anxiety intensity scores.(before surgery, postoperative day 3)
- The number of doses of metamizol as a "rescue drug"(postoperative day: 0-3)
研究者
Lucyna Tomaszek, PhD, RN
Head of Nursing, Specialist Nurse in Anesthesia and Intensive Care
National Institute for Tuberculosis and Lung Diseases, Poland