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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: January 1, 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac
    • Intravenous Magnesium sulfate combined to Diclofenac
  • Active Comparator: intravenous lidocaine combined to diclofenac
    • intravenous lidocaine combined to diclofenac
  • Active Comparator: diclofenac alone
    • diclofenac alone

Clinical Trial Outcome Measures

Primary Measures

  • 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%.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Monastir
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pr. Semir Nouira, Professor – University of Monastir
  • Overall Official(s)
    • Nouira semir, professor, Principal Investigator, university of ùmonastir

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