Intravenous Magnesium Sulfate Combined to Diclofenac Versus Intravenous Lidocaine Combined to Diclofenac Versus Diclofenac Alone in the ED Treatment of Renal Colic. A Randomized Double Blind Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Treatment success evaluated at 30 minutes after drug administration.
研究概览
简要总结
to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid consumption.
详细描述
Magnesium (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 a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.
Objective of study :
The aim of this study is to 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 emergency department 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent.
- •Age > 18years.
- •Confirmed renal colic
- •With moderate to severe pain (visual analogic Scale ≥4).
排除标准
- •Current regular use of analgesics, anticonvulsants, or antidepressants.
- •Analgesia taken within 24 hours .
- •Renal disorder with a low glomerular filtration rate (< 60ml/min)
- •Neuromuscular disorder.
- •Severe cardiac disease.
- •Pregnant women
- •Contraindication to one of the protocol treatment
- •Inability of the patient to cooperate
- •Allergy to NSAID or lidocaine.
研究组 & 干预措施
Intravenous Magnesium sulfate combined to Diclofenac
Intravenous Magnesium sulfate combined to Diclofenac
干预措施: Diclofenac (Drug)
Intravenous Magnesium sulfate combined to Diclofenac
Intravenous Magnesium sulfate combined to Diclofenac
干预措施: Magnesium Sulfate (Drug)
intravenous lidocaine combined to diclofenac
intravenous lidocaine combined to diclofenac
干预措施: Diclofenac (Drug)
intravenous lidocaine combined to diclofenac
intravenous lidocaine combined to diclofenac
干预措施: Lidocaine (Drug)
diclofenac alone
diclofenac alone
干预措施: Diclofenac (Drug)
结局指标
主要结局
Treatment success evaluated at 30 minutes after drug administration.
时间窗: 30 minutes
we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration.
Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration.
时间窗: 90 minutes
elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.
次要结局
- The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes(30 minutes)
- The need for additional analgesics at 30 minutes after protocol start to relieve the pain(30 minutes)
- Adverse effect(90 minutes)
研究者
Pr. Semir Nouira
Professor
University of Monastir