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Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Active Comparator | Intravenous Magnesium Sulfate combined to Diclofenac |
|
| Lidocaine | Active Comparator | Intravenous lidocaine combined to Diclofenac |
|
| Diclofenac | Active Comparator | Intramuscular Diclofenac alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate and diclofenac | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, Professor | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia | Monastir | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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Double blind study
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|
| Lidocain and diclofenac | Drug | 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. |
|
|
| Placebo and diclofenac | Drug | 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. |
|
|
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 |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |