Efficacy and Safety of Nebulized Morphine Given at Two Different Doses Compared to Intravenous Morphine in Post-traumatic Acute Pain: a Randomized Controlled Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain resolution
研究概览
简要总结
The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration:
- intravenous titrated morphine
- low dose nebulized morphine and
- high dose nebulized morphine
详细描述
Trauma patients are frequent in emergency department settings, and often require urgent care.
taking care of this patients consists on taking care of their pain and then the specific treatment of their traumatic lesions.
actually, the most used medicine and most efficient one in treating pain is morphine, it's mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit neurotransmitter release.
The most applied administration root of morphine is by intravenous (IV) titration or IV continuous perfusion, but until now, there is no clear recommendation concerning the superiority of this root over other administration techniques such as nebulization.
In this study we aimed to investigate the efficiency, the feasibility and the tolerance of three morphine administration roots in patients with acute traumatic pain and to clarify the most adequate one to apply in emergency department settings.
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, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients older than 8 years and less than 50 years
- •patients who consult emergency department for sever pain after an immediately trauma
排除标准
- •Glasgow coma scale <14
- •inability to cooperate
- •hypotension with systolic blood pressure< 90mmhg
- •bradypnea<12cpm
- •SAO2<90%
- •polytrauma
- •nasal trauma
- •nasal obstruction
- •allergy to opioids
研究组 & 干预措施
IV titrated morphine
patient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo).
Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS > 50%, 30 minutes after the beginning of the protocol.
干预措施: IV titrated morphine (Drug)
Low dose nebulised morphine
patient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo
干预措施: Low dose nebulised morphine (Drug)
High dose nebulised morphine
patient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo.
干预措施: High dose nebulised morphine (Drug)
结局指标
主要结局
Pain resolution
时间窗: 30 minutes
primary end point defined by the decrease in intensity pain objectified by a decline in visual analogy pain scale greater than or equal to 50% of its initial value
次要结局
- side effects(30 minutes)
研究者
Nouira
Professor
University of Monastir