NCT00964639已完成4 期
Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Difference in pain measured with r-FLACC between the 2 groups
研究概览
简要总结
This study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with Naropine.
Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 18
- •informed consent
- •Postoperative cast with spica
排除标准
- •Previous surgery in the same hip
- •Other surgical procedure planned at the same time
- •Bilateral surgery
- •Previous allergic reaction to local analgesia
研究组 & 干预措施
Saline
Placebo Comparator
干预措施: Saline (Drug)
Naropin
Active Comparator
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Difference in pain measured with r-FLACC between the 2 groups
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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