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

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ClinicalTrials.gov Identifier: NCT03199924
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double 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 : July 1, 2016
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : December 1, 2018


Arm Intervention/treatment
Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac 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

Active Comparator: intravenous lidocaine combined to diclofenac Drug: Diclofenac
Intramuscular injection of 75mg / 3ml of Diclofenac solution

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

Active Comparator: diclofenac alone Drug: Diclofenac
Intramuscular injection of 75mg / 3ml of Diclofenac solution




Primary Outcome Measures :
  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 Outcome Measures :
  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 additionnal analgesics at 30 minutes after protocol start to releive the pain [ Time Frame: 30 minutes ]
    The need for rescue analgesia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199924


Contacts
Contact: semir nouira, professor semir.nouira@rns.tn

Locations
Tunisia
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Recruiting
Monastir, Tunisia, 5000
Contact: semir nouira, professor       semir.nouira@rns.tn   
Sponsors and Collaborators
University of Monastir

Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT03199924     History of Changes
Other Study ID Numbers: COL-NEPHR
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pr. Semir Nouira, University of Monastir:
acute pain
Renal colic
Diclofenac
Lidocain
Magnesium sulfate

Additional relevant MeSH terms:
Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Magnesium Sulfate
Diclofenac
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticonvulsants
Calcium Channel Blockers