Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain (Morphine-Mida)
Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.
Administration of midazolam with morphine in patients with severe acute pain is a routine practice in the management of pre- and post-operative patients but has not been evaluated in pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam in the pre-hospital management of traumatic patients with severe acute pain.
In a multicenter prospective randomized double-blind placebo-controlled trial, the investigators would like to compare the analgesic effect and safety of the intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a validated numeric rating scale (NRS).
The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.
研究概览
详细说明
Patient will be included in pre-hospital setting. They must have an acute pain NRS greater than or equal to 6 from a traumatic origin. The participation of the study for each patient will be the time of the pre-hospital setting. The study will stop when the patient arrives at the hospital.
Patient will be randomized after obtaining an informed consent. Then, the nurse will administered intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg or intravenous morphine 0.10 mg/kg and placebo.
Only the nurse will be aware of the treatment received by the patient. Every 5 minutes, life constants and pain score will be recorded on the case report form.
Assessment will be done at the baseline using a validated numeric rating scale. The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Brest、法国、29609
- CHU de Brest
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Carhaix、法国、29270
- CH de Carhaix
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Nantes、法国、44000
- CHU de Nantes
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Quimper、法国、29000
- Centre Hpistalier Intercommunal de Cornouaille
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 to 70 years old
- conscient with spontaneous ventilation
- acute pain with an traumatic origin : pain escape superior or egal to 6/10
- taking care by French reanimation and urgency mobile services (Smur).
Exclusion Criteria:
- younger than 18 years old or older than 70 years old
- chronical respiratory insufficiency
- severe hepatocellular insufficiency,
- myasthenia
- known allergy to morphine or benzodiazepin,
- already treated for a chronical pain,
- pregnant women
- treated by morphine
- patient unable to evaluate his/her pain
- any acute and severe hemodynamic, respiratory or neurologic deficiency
- needed an local analgesia
- patient who received an other antalgic treatment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Midazolam
Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
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Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
其他名称：
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安慰剂比较：Placebo
Placebo at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain score
大体时间：20 minutes
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The primary outcome was the proportion of patients with a pain score less than or equal to 3 after 20 minutes
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20 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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pain evolution
大体时间：every 5 minutes and at the end of the study
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The secondary outcomes were in between-group comparison of: - pain score every 5 minutes during 30 minutes |
every 5 minutes and at the end of the study
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Safety
大体时间：during all the study
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The secondary outcomes were in between-group comparison of: - The treatment safety |
during all the study
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Morphine total dose
大体时间：During all the study
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The secondary outcomes were in between-group comparison of: - The total morphine dose required until obtaining pain score less than or equal to 3 |
During all the study
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合作者和调查者
调查人员
- 首席研究员：Yannick AUFFRET, Dr、Centre Hospitalier Intercommunal de Cornouaille
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Midazolam的临床试验
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University of CologneUmm Al-Qura University完全的