Prospective Randomized Trial Using Medrol Dose Packs for Post-Operative Pain Control
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) pain
研究概览
简要总结
The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.
详细描述
Post-operative pain control following AIS surgery is challenging. Sub-optimal pain management results in emotional distress and prolonged hospital length of stay. Previous studies have shown that a short course of steroids following spine surgery is safe and improves pain control. To better understand the effects of the addition of steroids to a routine pain management strategy, a randomized prospective study with and without steroids will determine the benefit, if any, to the addition of steroids to the investigators already used pain protocol.
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
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range of 10-21
- •received AIS surgery
排除标准
- •participants out of the age range 10-21
- •other forms of scoliosis (not AIS)
研究组 & 干预措施
Placebo tablets
Encapsulated placebo tablets per day (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg.)
干预措施: Placebo (Drug)
Medrol tablets
Encapsulated steroid Medrol tablets (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg)
干预措施: Medrol (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) pain
时间窗: Day 6, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
次要结局
未报告次要终点
研究者
Joshua Klatt
Principle Investigator
University of Utah