- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199924
Treatment of Renal Colic in the Emergency Departement (ED).
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Monastir, Tunisia, 5000
- Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
Other Names:
|
Active Comparator: intravenous lidocaine combined to diclofenac
|
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Other Names:
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
Other Names:
|
Active Comparator: diclofenac alone
|
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Other Names:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Infant, Newborn, Diseases
- Renal Colic
- Colic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Membrane Transport Modulators
- Anticonvulsants
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Lidocaine
- Anti-Inflammatory Agents
- Diclofenac
- Magnesium Sulfate
Other Study ID Numbers
- COL-NEPHR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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