IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale Score to measure pain reduction
研究概览
简要总结
Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. This study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to emergency department.
详细描述
Siatalgia is one of the main symptoms related to emergency department presentations. Patients with sciatalgia are seeking for immediate pain relief and little known regarding the pain management of these patients in emergency department. Neuronal compression is the main cause of pain in sciatalgia rather than inflammation which also differ sciatalgia from the other type of pains in emergency department. Sciatalgia is a kind of neuralgia and there is not so much option in the pain management of these patients. Intravenous paracetamol and morphine is commonly used analgesics in various kind of pain in emergency department. So, this study aim to trial the effect of intravenous paracetamol and morphine in patients presented with sciatalgia to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pain radiating to the sciatic nerve path
- •Pain within the last one week
- •Patients with positive straight leg raise
- •Patients over 21 and lower than 65 years old
排除标准
- •Pain score lower than 40 mm in visual analogue scale score
- •Neurological deficit
- •Allergy to the study drugs
- •Unstable vital signs
- •History of malignancy or rheumatological diseases or arthritis
- •History of chronic pain syndrome
- •Receiving pain killer, steroid, anti-depressant, anti-convulsant and musculorelaxant within the last six hours.
- •Drug or alcohol addiction
- •Pregnancy or breast feeding
- •Fewer more than 37.9 Celsius degrees.
研究组 & 干预措施
Paracetamol
1 g intravenous paracetamol (Perfalga, Bristol Myers) in 100 ml saline with a rapid infusion.
干预措施: Paracetamol (Drug)
morphine
0.1 mg/kg morphine in 100 ml saline with a rapid infusion.
干预措施: morphine (Drug)
placebo
100 ml saline
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analogue Scale Score to measure pain reduction
时间窗: 30 minutes
Visual Analogue Scale Score at 30 minutes in order to measure pain reduction
次要结局
- Adverse effects(30 minutes)
- Rescue drug need questionnaire(30 minutes)
研究者
Cenker Eken
Associate Proffesor
Akdeniz University