NCT03199924

Treatment of Renal Colic in the Emergency Departement (ED).

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Colic

Interventions

Type	Name	Description
DRUG	Diclofenac	Intramuscular injection of 75mg / 3ml of Diclofenac solution
DRUG	Magnesium Sulfate	intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
DRUG	Lidocaine	intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-01-01
• Completion: 2022-07-31
• First posted: 2017-06-27
• Last updated: 2022-08-10

Locations

1 site across 1 country: Tunisia