Treatment of Renal Colic in the Emergency Departement (ED).
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|ClinicalTrials.gov Identifier: NCT03199924|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Colic||Drug: Diclofenac Drug: Magnesium Sulfate Drug: Lidocaine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind study|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||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.|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||January 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
|Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac||
Intramuscular injection of 75mg / 3ml of Diclofenac solutionDrug: Magnesium Sulfate
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
|Active Comparator: intravenous lidocaine combined to diclofenac||
Intramuscular injection of 75mg / 3ml of Diclofenac solutionDrug: Lidocaine
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
|Active Comparator: diclofenac alone||
Intramuscular injection of 75mg / 3ml of Diclofenac solution
- Treatment success evaluated at 30 minutes after drug administration. [ Time Frame: 30 minutes ]we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration.
- Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration. [ Time Frame: 90 minutes ]elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.
- The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes [ Time Frame: 30 minutes ]The proportion of patients achieving a drop in initial pain score of at least 3
- Adverse effect [ Time Frame: 90 minutes ]eg nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol
- The need for additionnal analgesics at 30 minutes after protocol start to releive the pain [ Time Frame: 30 minutes ]The need for rescue analgesia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199924
|Contact: semir nouira, email@example.com|
|Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia||Recruiting|
|Monastir, Tunisia, 5000|
|Contact: semir nouira, professor firstname.lastname@example.org|