Treatment of Renal Colic in the Emergency Departement (ED).
Primary Purpose
Renal Colic
Status
Completed
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
Diclofenac
Magnesium Sulfate
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring acute pain, Renal colic, Diclofenac, Lidocain, Magnesium sulfate
Eligibility 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.
Sites / Locations
- Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Intravenous Magnesium sulfate combined to Diclofenac
intravenous lidocaine combined to diclofenac
diclofenac alone
Arm Description
Intravenous Magnesium sulfate combined to Diclofenac
intravenous lidocaine combined to diclofenac
diclofenac alone
Outcomes
Primary Outcome Measures
Treatment success evaluated at 30 minutes after drug administration.
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.
elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.
Secondary Outcome Measures
The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes
The proportion of patients achieving a drop in initial pain score of at least 3
Adverse effect
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
The need for rescue analgesia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03199924
Brief Title
Treatment of Renal Colic in the Emergency Departement (ED).
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
acute pain, Renal colic, Diclofenac, Lidocain, Magnesium sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double blind study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Magnesium sulfate combined to Diclofenac
Arm Type
Active Comparator
Arm Description
Intravenous Magnesium sulfate combined to Diclofenac
Arm Title
intravenous lidocaine combined to diclofenac
Arm Type
Active Comparator
Arm Description
intravenous lidocaine combined to diclofenac
Arm Title
diclofenac alone
Arm Type
Active Comparator
Arm Description
diclofenac alone
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Non Steroidal Anti Inflammatories, Voltaren
Intervention Description
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
MgSO4, Sulfamag
Intervention Description
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
lignocaine, Xylocaine
Intervention Description
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
Primary Outcome Measure Information:
Title
Treatment success evaluated at 30 minutes after drug administration.
Description
we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration.
Time Frame
30 minutes
Title
Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration.
Description
elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes
Description
The proportion of patients achieving a drop in initial pain score of at least 3
Time Frame
30 minutes
Title
Adverse effect
Description
eg nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol
Time Frame
90 minutes
Title
The need for additional analgesics at 30 minutes after protocol start to relieve the pain
Description
The need for rescue analgesia
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira semir, professor
Organizational Affiliation
university of ùmonastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Renal Colic in the Emergency Departement (ED).
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