Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Numeric Pain Intensity Scale
研究概览
简要总结
This is a randomized control trial to evaluate the efficacy of an FDA approved cold therapy device vs. usual care among children undergoing appendectomy at a large children's hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 7 years of older
- •Diagnosis of appendicitis and scheduled appendectomy
排除标准
- •Neurologic and Decision Impairment
- •Chronic opioid dependency
- •Planned ICU admission post-operatively
- •Reoperation during hospital stay
- •Ward of the state
- •Non-english and non-spanish speakers
研究组 & 干预措施
Cold Therapy & Standard Post Operative Analgesia
Patients in the cryotherapy group will have the ice water in their cryotherapy device maintained continuously for 2 days from initial application as this is the reported time of average patient disability and children typically return to school by post-operative day 3. The device will not be placed directly on the skin to minimize tissue damage. An additional protective barrier pad included with the cold therapy device will provide a barrier between the skin and the cooling device. This allows for continuous cooling at a higher target skin temperature. Aside from the cryotherapy, all surgical treatment will be standard of care.
干预措施: Standard of Care (Other)
Cold Therapy & Standard Post Operative Analgesia
Patients in the cryotherapy group will have the ice water in their cryotherapy device maintained continuously for 2 days from initial application as this is the reported time of average patient disability and children typically return to school by post-operative day 3. The device will not be placed directly on the skin to minimize tissue damage. An additional protective barrier pad included with the cold therapy device will provide a barrier between the skin and the cooling device. This allows for continuous cooling at a higher target skin temperature. Aside from the cryotherapy, all surgical treatment will be standard of care.
干预措施: Cold Therapy (Device)
Standard Post Operative Analgesia
干预措施: Standard of Care (Other)
结局指标
主要结局
Numeric Pain Intensity Scale
时间窗: Post operative days 1-3
The primary outcome variable in this trial is pain score as reported on the Numeric Pain Intensity Scale. These scores will be self-reported (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented once daily.
次要结局
- Mean Morphine Metabolic Equivalents (MME)(Limited to duration of hospital stay, up to 1 month)
- Length of Hospital Stay(Duration of stay in hospital post-operatively, up to 1 month)
- Time to Return of Tolerating Solid Food(Duration of time until beginning to tolerate solid food, up to 1 month)
研究者
Heung Bae Kim
Professor of Surgery
Boston Children's Hospital