Treatment of Renal Colic in the Emergency Departement (ED).

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: Diclofenac
* Drug: Magnesium Sulfate
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent. Age > 18years. Confirmed renal colic With moderate to severe pain (visual analogic Scale ≥4). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac<br>Intravenous Magnesium sulfate combined to Diclofenac | Drug: Diclofenac<br>* Intramuscular injection of 75mg / 3ml of Diclofenac solution<br>* Other names: Voltaren;Drug: Magnesium Sulfate<br>* intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes<br>* Other names: Sulfamag;|
| Active Comparator: intravenous lidocaine combined to diclofenac<br>intravenous lidocaine combined to diclofenac | Drug: Diclofenac<br>* Intramuscular injection of 75mg / 3ml of Diclofenac solution<br>* Other names: Voltaren;Drug: Lidocaine<br>* intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes<br>* Other names: Xylocaine;|
| Active Comparator: diclofenac alone<br>diclofenac alone | Drug: Diclofenac<br>* Intramuscular injection of 75mg / 3ml of Diclofenac solution<br>* Other names: Voltaren;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success evaluated at 30 minutes after drug administration. | we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration. | 30 minutes | 
| Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration. | elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%. | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes | The proportion of patients achieving a drop in initial pain score of at least 3 | 30 minutes | 
| Adverse effect | eg nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol | 90 minutes | 
| The need for additional analgesics at 30 minutes after protocol start to relieve the pain | The need for rescue analgesia | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, Renal colic, Diclofenac, Lidocain, Magnesium sulfate