Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- change in child's pain intensity score
研究概览
简要总结
The objective of the study is to compare the efficacy of gabapentin and amitriptyline for treating neuropathic pain in children in a randomized controlled trial.
详细描述
Clinical experience and case reports suggest that both amitriptyline and gabapentin are effective treatments for neuropathic pain in children; however we do not know which drug is more effective for specific pain conditions or for specific children. This study will be the first prospective, randomized double-blind controlled trial directly comparing gabapentin and amitriptyline for the treatment of neuropathic pain in a paediatric population. We will also study the time course for pain reduction and evaluate changes in children's physical function, mood, and sleep. This information is needed to determine which drug is better for which children and which pain conditions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 - 17 years of age
- •Diagnosis of neuropathic pain
排除标准
- •Additional health problems
- •Lactose intolerant
- •Unable to swallow size 0 gelatin capsules
- •Unable to speak English
研究组 & 干预措施
1
干预措施: Gabapentin (Drug)
2
干预措施: Amitriptyline (Drug)
结局指标
主要结局
change in child's pain intensity score
时间窗: 6 weeks
次要结局
- change in child's pain-related disability ratings(6 weeks)
研究者
Stephen Brown
Staff Anesthesiologist
The Hospital for Sick Children