CTRI/2024/12/078718尚未招募2 期
Comparison of efficacy of Gabapentin and Pregabalin in reducing pain intensity in children with Guillain Barre syndrome 4-18 years of age: a single blind randomized controlled pilot trial
Prateek Kumar Panda1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity in bilateral legs measured by the investigator using the visual analog scale on a scale of 0-10
研究概览
简要总结
This single-blind randomized controlled trial will recruit children aged 4-18 with a confirmed diagnosis of Guillain Barre syndrome and neuropathic pain. Forty children will be randomized to receive either oral gabapentin or pregabalin for seven days. We will measure the pain intensity in bilateral legs and back on day 3 and day 7 after starting the study medication and compare the results between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of GBS Presence of neuropathic pain with severity measured by visual analogue score of 4 or more.
排除标准
- •Any major chronic systemic illness Previous documented allergy to either gabapentin or pregabalin.
结局指标
主要结局
Pain intensity in bilateral legs measured by the investigator using the visual analog scale on a scale of 0-10
时间窗: Day 3 and day 7 after starting study medication
次要结局
- Pain intensity in back measured by the investigator using the visual analog scale on a scale of 0-10(Day 3 and day 7 after starting study medication)
研究者
Dr Prateek Kumar Panda
All India Institute of Medical Sciences, Rishikesh
研究点 (1)
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