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

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT03199924

Collaborator

(none)

600

Enrollment

Location

Arms

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Colic	Drug: Diclofenac Drug: Magnesium Sulfate Drug: Lidocaine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind studyDouble blind study

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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 :

Jul 1, 2016

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac Intravenous Magnesium sulfate combined to Diclofenac	Drug: Diclofenac Intramuscular injection of 75mg / 3ml of Diclofenac solution Other Names: Non Steroidal Anti Inflammatories Voltaren Drug: Magnesium Sulfate intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes Other Names: MgSO4 Sulfamag
Active Comparator: intravenous lidocaine combined to diclofenac intravenous lidocaine combined to diclofenac	Drug: Diclofenac Intramuscular injection of 75mg / 3ml of Diclofenac solution Other Names: Non Steroidal Anti Inflammatories Voltaren Drug: Lidocaine intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes Other Names: lignocaine Xylocaine
Active Comparator: diclofenac alone diclofenac alone	Drug: Diclofenac Intramuscular injection of 75mg / 3ml of Diclofenac solution Other Names: Non Steroidal Anti Inflammatories Voltaren

Arm

Intervention/Treatment

Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac

Intravenous Magnesium sulfate combined to Diclofenac

Drug: Diclofenac

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Other Names:

Non Steroidal Anti Inflammatories

Voltaren

Drug: Magnesium Sulfate

intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes

Other Names:

MgSO4

Sulfamag

Active Comparator: intravenous lidocaine combined to diclofenac

intravenous lidocaine combined to diclofenac

Drug: Diclofenac

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Other Names:

Non Steroidal Anti Inflammatories

Voltaren

Drug: Lidocaine

intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes

Other Names:

lignocaine

Xylocaine

Active Comparator: diclofenac alone

diclofenac alone

Drug: Diclofenac

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Other Names:

Non Steroidal Anti Inflammatories

Voltaren

Outcome Measures

Primary Outcome Measures

Treatment success evaluated at 30 minutes after drug administration. [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. [90 minutes]
elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.

Secondary Outcome Measures

The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes [30 minutes]
The proportion of patients achieving a drop in initial pain score of at least 3
Adverse effect [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 additional analgesics at 30 minutes after protocol start to relieve the pain [30 minutes]
The need for rescue analgesia