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临床试验/NCT00309673
NCT00309673Unknown不适用

Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年4月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Measurement of tuberculin skin tests reaction performed with and without

研究概览

简要总结

The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when tuberculin skin test is performed it is the skin reaction to tuberculin injection that is studied. It is a quantitative skin reaction measured in millimiters. From the study of literature it is not known whether local anaesthetic modify skin reaction to tuberculin. Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection we have to rule out a potential effect of local anaesthetic on the result of the test. This is particularly important in children, since there are more sensitive to pain than adults

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
1 Month 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • hospitalized or non hospitalized infant or child (3 months-15 years)requiring a tuberculin skin test, in our hospital. hospitalized 1 to 3 months old infants requiring a tuberculin skin test, in our hospital.

排除标准

  • child with contra indication to the use of Lidocaine / prilocaine
  • child with evolutive dermatitis on forearms
  • premature or newborn (less than 1 month of age)
  • infants (1 - 24 months of age)who has yet received repeated local anaesthesia (at least 2)during the 24 previous hours
  • infants (1 - 24 months of age)who is treated with a drug that could enhance the risk of methhaemoglobinemia
  • child with previous evere local reaction to tuberculin injection (necrosis,ulceration)
  • child with history of tuberculosis disease
  • child with hepatic failure
  • parents or the child himself if lod enough, have not given their agreement for the study

结局指标

主要结局

Measurement of tuberculin skin tests reaction performed with and without

local anaesthesia, in a child (intra subject reproducibility)

次要结局

  • influence of local anaesthesia use, on tuberculin skin test interpretation
  • between observer reproducibility
  • pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
  • relationship between local anaesthesia use and failure to perform a correct intradermal injection
  • local tolerance to lidocaine / prilocaine

研究者

申办方类型
Other

研究点 (2)

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