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临床试验/NCT02995525
NCT02995525已完成不适用

Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
pain at 4 months after surgery

研究概览

简要总结

The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.

The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years.

The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital.

排除标准

  • patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.

结局指标

主要结局

pain at 4 months after surgery

时间窗: 4 months after scoliosis and thoracic surgery in children aged 6 to 18 years

visual analogue scale for pain (0_100)

次要结局

  • adverse events after surgery(adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery))
  • prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery(2'4-48 h hours period after surgery, 4 months after surgery)
  • morphine consumption during the perioperative period(the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization))
  • pain at 4 months after surgery(4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years)
  • pain during the perioperative period(the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization))
  • pain during the perioperative period in disabled children aged 6 to 18 years(the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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