Clinical Randomized Study of Sublingual Midazolam in Association With Morphine by Oral Route in Arm Fracture in Children at the Emergency Children Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in the measurement of pain analogical scale values at 30 minutes between the two groups
研究概览
简要总结
It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.
详细描述
Fracture is often responsible of pain in the paediatric emergency department (ED). This pain is very severe and needs effective drugs.
During a study made at the ED of Necker Enfants Malades Hospital, it has been shown that the oral morphine had a limited action on this kind of pain. Therefore it is interesting to increase the analgesia by making a drug association, for example with the midazolam witch is a benzodiazepine with a sedative and anxiolytic action, and which has got the MMA for the intravenous and the intra rectal forms for children older than 6 months.
The intravenous form has some disadvantages like an extra work and an increase of risk of side effects.
That is why the sublingual form seems to be interesting in this context. Even if some studies have shown the benefit of midazolam as a preanesthetic medication given to children scheduled for a surgical procedure, none has shown the interest of sublingual midazolam associated with oral morphine to relieve the pain due to a displaced fracture.
The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 5 and 16 years old
- •children with a disjoined bone fracture
- •children needed oral morphine analgesia
- •written informed consent from one or the two parents or legal pad
排除标准
- •ASA score > 2
- •concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
- •concomitant administration of benzodiazepine less than 24 hours
研究组 & 干预措施
1
Midazolam and morphine
干预措施: Midazolam (Drug)
2
placebo, Nacl 0.9 %, morphine 0.5 mg/kg
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in the measurement of pain analogical scale values at 30 minutes between the two groups
时间窗: after administration until 120 minutes
次要结局
- Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.(after administration until 120 minutes)
- Pain Analogical scale Values after the treatment of the fracture(after administration until 120 minutes)
- Respiratory rate, Oxymetry(after administration until 120 minutes)
- Conscience (lethargy or irritability)(after administration until 120 minutes)
- nausea,(after administration until 120 minutes)
- skin hyperesthesia, rash(after administration until 120 minutes)
- children cooperation(after surgical procedure)