Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. Resolution rate
研究概览
简要总结
In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults.
It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%
- •Age between 8 and 50 years.
排除标准
- •Glasgow coma scale (GCS)< 14,
- •Severe injury ,
- •Hypotension : blood systolic pressure < 90 mmhg,
- •Bradypnea < 12 cpm or SaO2< 90%,
- •Chronic pain treatment,
- •Aspirin or paracetamol treatment within 6 hours of emergency presentation,
- •Nasal trauma, rhinitis, nasal obstruction,
- •Incapacity to cooperate,
- •Opiate allergy,
- •Drug addiction,
- •Pregnancy, breast feeding,
- •Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)
研究组 & 干预措施
Nebulized Morphine
After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .
干预措施: nebulized morphine (Drug)
Nebulized Morphine
After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .
干预措施: Intravenous morphine (Drug)
Intravenous morphine
After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%).
干预措施: Intravenous morphine (Drug)
结局指标
主要结局
1. Resolution rate
时间窗: one hour
resolution is defined as VAPS \<30%.
次要结局
- Resolution time(one hour)
- rate of side effects(one hour)
研究者
Nouira
Professor
University of Monastir