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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Magnesium sulfate combined to Diclofenac | Active Comparator | Intravenous Magnesium sulfate combined to Diclofenac |
|
| intravenous lidocaine combined to diclofenac | Active Comparator | intravenous lidocaine combined to diclofenac |
|
| diclofenac alone | Active Comparator | diclofenac alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | Intramuscular injection of 75mg / 3ml of Diclofenac solution |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nouira semir, professor | university of ùmonastir | 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 |
|---|---|
| D004008 | Diclofenac |
| D008278 | Magnesium Sulfate |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double blind study
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|
| Magnesium Sulfate | Drug | intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes |
|
|
| Lidocaine | Drug | intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes |
|
|
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 |
| D017616 |
| Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |