Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Monastir, 5000, Tunisia
NCT Number: NCT05653401
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Monastir, 5000, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Intravenous Magnesium Sulfate combined to Diclofenac
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.
Other names: Intravenous Lidocain combined to Diclofenac
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.
Other names: Diclofenac alone with placebo ( serum saline )
Time frame: 30 minutes
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 )
Time frame: 90 min
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
Time frame: 90 minutes
nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol
Time frame: 30 minutes
The need for rescue analgesia
University of Monastir
Other
Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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