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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相关药物
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
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