Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
研究概览
简要总结
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
详细描述
Magnesium Sulfate (MgSO4) is a N-Methyl-D-aspartate (NMDA) receptor antagonist and is thought to be involved in the modulation of pain. There has been little direct evidence that MgSO4 relieve neuropathic pain and prevents opioid-induced hyperalgesia in humans.
Intramuscular Diclofenac seems to offer the most effective sustained analgesia for renal colic in the ED and has few side effects.
Lidocain became the agent of choice in visceral and central pain. Intravenous Lidocain is effective in the management of neuropathic pain such as diabetic neuropathy, post-surgical pain, post-herpetic pain, headaches and neurological malignancies. At low doses, Lidocain is known as a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.
Objective of study:
Evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous Lidocain combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the ED with renal colic and whether it can reduce opioid consumption.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent.
- •Age between 18 and 65 years .
- •Diagnosis of renal colic made by an emergency medicine physician, based on history and clinical findings, and urine analysis or by identifying the urinary tract stone using ultrasonography or radiologic imaging including CT scan .-With moderate to severe pain (visual analogic Scale ≥5 ).
排除标准
- •known renal or hepatic dysfunction, use of NSAIDs and/or opioids within 6 h before presentation
- •history of bleeding diathesis, history of peptic ulcer disease or gastrointestinal hemorrhage,
- •History of cardiac arrhythmia, severe coronary artery disease, seizures, presence of any peritoneal sign, altered mental status, and anticoagulant medication or coagulation disorders.
- •Use of any analgesics or spasmolytics in the previous 4 hours before admission, hemodynamic instability, and prior known allergy to lidocaine or morphine .
- •Pregnant women , Breast feeding
- •Allergy or contraindications to NSAIDs, lidocaine or MgSO 4
研究组 & 干预措施
Magnesium Sulfate
Intravenous Magnesium Sulfate combined to Diclofenac
干预措施: Magnesium sulfate and diclofenac (Drug)
Lidocaine
Intravenous lidocaine combined to Diclofenac
干预措施: Lidocain and diclofenac (Drug)
Diclofenac
Intramuscular Diclofenac alone
干预措施: Placebo and diclofenac (Drug)
结局指标
主要结局
Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
时间窗: 30 minutes
Significant pain reduction as at least a 50% drop of VAS Score of the initial pain score at 30 min after analgesia administration ( Drop VAS Score is in favour of analgesic treatment efficiency )
次要结局
- The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)(90 min)
- Adverse effect(90 minutes)
- The need for additional analgesics at 30 minutes after protocol start to relieve the pain(30 minutes)
研究者
Pr. Semir Nouira
Professor
University of Monastir