Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessment of the value of the pain feeling
研究概览
简要总结
Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.
To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.
The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 points)
- •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
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
研究组 & 干预措施
Intranasal fentanyl + Oral placebo
Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
干预措施: Intranasal fentanyl + Oral Placebo (Drug)
Oral morphine + Intranasal placebo
Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
干预措施: Oral Morphine + Intranasal Placebo (Drug)
结局指标
主要结局
Assessment of the value of the pain feeling
时间窗: 45 minutes
Assessment of the value of the pain feeling measured by visual analogic scale
次要结局
- Delay in treatment efficacy(up to 45 minutes)