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临床试验/EUCTR2016-003658-34-FR
EUCTR2016-003658-34-FR进行中(未招募)1 期

on-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study - FINDO

niversity Hospital of Montpellier0 个研究点开始时间: 2017年1月10日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Patient aged between 4 years old and 15,3 years old
  • -Acute pain in traumatic context with a suspicion of fracture
  • for patient <7years old : feeling Pain>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not <10 oints)
  • - For patients >7 years old : feeling pain >6 points and defined thanks to a visual analogic scale
  • -Informed consent form signed by parents
  • - Beneficiary of an european health protection
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 82
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Antalgic ( II or III) within 4 hours before the inclusion
  • Allergic or non-indication of fentanyl
  • Allergic or contraindication of morphine sulfate
  • pre Existing peripheral intravenous catheter
  • Traumatic brain injury
  • nasal traumatic

研究者

发起方
niversity Hospital of Montpellier

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