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Completed

NCT Number: NCT03199924

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

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.

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Key information

Conditions

Renal Colic Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac

Drug

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Other names: Non Steroidal Anti Inflammatories, Voltaren

Magnesium sulfate

Drug

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

Other names: MgSO4, Sulfamag

Lidocaine

Drug

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

Other names: lignocaine, Xylocaine

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

  2. 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

  3. The need for additional analgesics at 30 minutes after protocol start to relieve the pain

    Time frame: 30 minutes

    The need for rescue analgesia

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2017
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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