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临床试验/NCT04986397
NCT04986397已完成不适用

Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年12月22日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heung Bae Kim

Professor of Surgery

Boston Children's Hospital

研究点 (2)

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