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临床试验/NCT00721682
NCT00721682已完成不适用

Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study

Nantes University Hospital7 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
7
主要终点
The principal judgement criterion is the proportion of children without recognized pain, measured with the rating scales validated in paediatrics, in T0, in the two populations of children (maltreated and others).

研究概览

简要总结

The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated children showed that they had very low scores of evaluation of the pain, in spite of severe traumatisms. There is, at the moment, no data in the literature on the acute pain of the maltreated children.

研究设计

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

入排标准

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

入选标准

  • Age between 0 and 6 years
  • Consultation in the emergency cares for traumatism with type of fracture and/or burn
  • Time of the traumatism lower than 24 hours
  • Information of the two parents or the parental authority and collection of the non-opposition.

排除标准

  • Old superior at 6 years
  • Any type of traumatism other than a fracture and/or a burn
  • Traumatism without possible dating or with a time of consultation higher than 24 hours
  • Opposition of the parents formulated after their information by the medical team
  • Child who can not have an evaluation of the pain with the chosen scales

结局指标

主要结局

The principal judgement criterion is the proportion of children without recognized pain, measured with the rating scales validated in paediatrics, in T0, in the two populations of children (maltreated and others).

时间窗: 3 years

次要结局

  • Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors(3 years)
  • Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology.(3 years)
  • Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others)(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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Evaluation of Acute Pain in Maltreated Children | 临床试验