Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduce the pain intensity using the Face Pain Scale
研究概览
简要总结
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.
详细描述
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery
排除标准
- •Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.
研究组 & 干预措施
Placebo
Placebo in children submitted unilateral limb surgery
干预措施: Placebo (Other)
Gabapentin
Gabapentin 10 mg/kg in children submitted unilateral limb surgery
干预措施: Gabapentin (Drug)
结局指标
主要结局
Reduce the pain intensity using the Face Pain Scale
时间窗: 24 hour
Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.
次要结局
- Reduce the opioid consumption through 24 hours postoperative observation(24 hour)
研究者
washington aspilicueta pinto filho
Medical Anesthesiologist
Hospital Infantil Albert Sabin