ACTRN12616000366459已完成3 期
A pilot study of gabapentin for managing pain in children with dystonic cerebral palsy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Years 至 18 Years(—)
- 性别
- All
入选标准
- •1)Confirmation of dystonia after completion of the Hypertonicity Assessment Tool (HAT). Those children who have dystonia or a mixed diagnosis (spasticity and dystonia) will be eligible.
- •2)Severity of dystonia will be determined with the Barry Albright Dystonia (BAD) scale. Children with a score of 15 or higher on the BAD scale will be eligible.
- •3)Pain will be quantified using the Health Utilities Index 3 (HUI 3). Those children scoring IV or V will be eligible.
排除标准
- •Children excluded from the study will be those who:
- •1.Are younger than 6 years because they will have more difficulty with reliably self-reporting and will not be able to perform some of the quantitative measurements.
- •2.Are currently on gabapentin or have been on gabapentin in the previous 3 months
- •3.Have demonstrated hypersensitivity to gabapentin or the inactive ingredients in the capsules in the past
- •4.Are currently taking other medications that may interact with gabapentin (i.e. antacid, cimetidine, morphine, and opioids).
- •5.Pregnant female participants
研究者
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