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Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.

Primary Purpose

Renal Colic

Status
Completed
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
Magnesium sulfate and diclofenac
Lidocain and diclofenac
Placebo and diclofenac
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic focused on measuring Acute pain, Renal colic, Magnesium Sulfate, Lidocain, Diclofenac

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent. Age between 18 and 65 years . Diagnosis of renal colic made by an emergency medicine physician, based on history and clinical findings, and urine analysis or by identifying the urinary tract stone using ultrasonography or radiologic imaging including CT scan .-With moderate to severe pain (visual analogic Scale ≥5 ). Exclusion Criteria: known renal or hepatic dysfunction, use of NSAIDs and/or opioids within 6 h before presentation history of bleeding diathesis, history of peptic ulcer disease or gastrointestinal hemorrhage, History of cardiac arrhythmia, severe coronary artery disease, seizures, presence of any peritoneal sign, altered mental status, and anticoagulant medication or coagulation disorders. Use of any analgesics or spasmolytics in the previous 4 hours before admission, hemodynamic instability, and prior known allergy to lidocaine or morphine . Pregnant women , Breast feeding Allergy or contraindications to NSAIDs, lidocaine or MgSO 4

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

Magnesium Sulfate

Lidocaine

Diclofenac

Arm Description

Intravenous Magnesium Sulfate combined to Diclofenac

Intravenous lidocaine combined to Diclofenac

Intramuscular Diclofenac alone

Outcomes

Primary Outcome Measures

Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
Significant pain reduction as at least a 50% drop of VAS Score of the initial pain score at 30 min after analgesia administration ( Drop VAS Score is in favour of analgesic treatment efficiency )

Secondary Outcome Measures

The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
Adverse effect
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

First Posted
December 7, 2022
Last Updated
September 19, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05653401
Brief Title
Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.
Official Title
Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (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
No

5. Study Description

Brief Summary
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
Detailed Description
Magnesium Sulfate (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 as a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic. Objective of study: 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 ED 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, Magnesium Sulfate, Lidocain, Diclofenac

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
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Sulfate
Arm Type
Active Comparator
Arm Description
Intravenous Magnesium Sulfate combined to Diclofenac
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Intravenous lidocaine combined to Diclofenac
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Description
Intramuscular Diclofenac alone
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate and diclofenac
Other Intervention Name(s)
Intravenous Magnesium Sulfate combined to Diclofenac
Intervention Description
Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 1 g of Magnesium Sulfate solution diluted in 10 ml of saline solution administered over 2 to 4 minutes
Intervention Type
Drug
Intervention Name(s)
Lidocain and diclofenac
Other Intervention Name(s)
Intravenous Lidocain combined to Diclofenac
Intervention Description
Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 10 ml of Lidocaine 1% solution administered over 2 to 4 minutes.
Intervention Type
Drug
Intervention Name(s)
Placebo and diclofenac
Other Intervention Name(s)
Diclofenac alone with placebo ( serum saline )
Intervention Description
Intramuscular injection of 75 mg of Diclofenac solution and 10 ml Intravenous injection of serum saline ( as a Placebo Comparator ) administered over 2 to 4 minutes.
Primary Outcome Measure Information:
Title
Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
Description
Significant pain reduction as at least a 50% drop of VAS Score of the initial pain score at 30 min after analgesia administration ( Drop VAS Score is in favour of analgesic treatment efficiency )
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
Description
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
Time Frame
90 min
Title
Adverse effect
Description
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
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent. Age between 18 and 65 years . Diagnosis of renal colic made by an emergency medicine physician, based on history and clinical findings, and urine analysis or by identifying the urinary tract stone using ultrasonography or radiologic imaging including CT scan .-With moderate to severe pain (visual analogic Scale ≥5 ). Exclusion Criteria: known renal or hepatic dysfunction, use of NSAIDs and/or opioids within 6 h before presentation history of bleeding diathesis, history of peptic ulcer disease or gastrointestinal hemorrhage, History of cardiac arrhythmia, severe coronary artery disease, seizures, presence of any peritoneal sign, altered mental status, and anticoagulant medication or coagulation disorders. Use of any analgesics or spasmolytics in the previous 4 hours before admission, hemodynamic instability, and prior known allergy to lidocaine or morphine . Pregnant women , Breast feeding Allergy or contraindications to NSAIDs, lidocaine or MgSO 4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, Professor
Organizational Affiliation
University of Monastir
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 Department: Comparison Between Magnesium Sulfate and Lidocaine.

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