Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.

Study Overview
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Brief Summary
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Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.

Detailed Description
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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.

Official Title
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Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: Magnesium sulfate and diclofenac
* Drug: Lidocain and diclofenac
* Drug: Placebo and diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Magnesium Sulfate<br>Intravenous Magnesium Sulfate combined to Diclofenac | Drug: Magnesium sulfate and diclofenac<br>* Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 1 g of Magnesium Sulfate solution diluted in 10 ml of saline solution administered over 2 to 4 minutes<br>* Other names: Intravenous Magnesium Sulfate combined to Diclofenac;|
| Active Comparator: Lidocaine<br>Intravenous lidocaine combined to Diclofenac | Drug: Lidocain and diclofenac<br>* Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 10 ml of Lidocaine 1% solution administered over 2 to 4 minutes.<br>* Other names: Intravenous Lidocain combined to Diclofenac;|
| Active Comparator: Diclofenac<br>Intramuscular Diclofenac alone | Drug: Placebo and diclofenac<br>* Intramuscular injection of 75 mg of Diclofenac solution and 10 ml Intravenous injection of serum saline ( as a Placebo Comparator ) administered over 2 to 4 minutes.<br>* Other names: Diclofenac alone with placebo ( serum saline );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration. | 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 ) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min) | The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min) | 90 min | 
| Adverse effect | 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, Magnesium Sulfate, Lidocain, Diclofenac