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

August 9, 2022 updated by: Pr. Semir Nouira, University of Monastir

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.

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Monastir, Tunisia, 5000
        • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Other Names:
  • Voltaren
  • Non Steroidal Anti Inflammatories
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
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Other Names:
  • Voltaren
  • Non Steroidal Anti Inflammatories
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
Other Names:
  • Xylocaine
  • lignocaine
Active Comparator: diclofenac alone
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Other Names:
  • Voltaren
  • Non Steroidal Anti Inflammatories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes
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%.
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes
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
90 minutes
The need for additional analgesics at 30 minutes after protocol start to relieve the pain
Time Frame: 30 minutes
The need for rescue analgesia
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

June 24, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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