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

Renal Colic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199924
• Other study ID #: COL-NEPHR
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2016
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent.

• Age > 18years.

• Confirmed renal colic

• With moderate to severe pain (visual analogic Scale =4).

Exclusion Criteria:

• Current regular use of analgesics, anticonvulsants, or antidepressants.

• Analgesia taken within 24 hours .

• Renal disorder with a low glomerular filtration rate (< 60ml/min)

• Neuromuscular disorder.

• Severe cardiac disease.

• Pregnant women

• Contraindication to one of the protocol treatment

• Inability of the patient to cooperate

• Allergy to NSAID or lidocaine.

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• Diclofenac
Intramuscular injection of 75mg / 3ml of Diclofenac solution
• Magnesium Sulfate
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
• Lidocaine
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes

Locations

Country	Name	City	State
Tunisia	Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Adverse effect	eg nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol	90 minutes
Secondary	The need for additional analgesics at 30 minutes after protocol start to relieve the pain	The need for rescue analgesia	30 minutes