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

Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.

Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.

Study Overview

• Status: Completed
• Conditions: Renal Colic
• Intervention / Treatment: Drug: Magnesium sulfate and diclofenac; Drug: Lidocain and diclofenac; Drug: Placebo and diclofenac

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.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 2

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium Sulfate; Intravenous Magnesium Sulfate combined to Diclofenac	Drug: Magnesium sulfate and diclofenac; 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; Other Names: Intravenous Magnesium Sulfate combined to Diclofenac
Active Comparator: Lidocaine; Intravenous lidocaine combined to Diclofenac	Drug: Lidocain and diclofenac; 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.; Other Names: Intravenous Lidocain combined to Diclofenac
Active Comparator: Diclofenac; Intramuscular Diclofenac alone	Drug: Placebo and diclofenac; 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.; Other Names: Diclofenac alone with placebo ( serum saline )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 )	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for additional analgesics at 30 minutes after protocol start to relieve the pain	The need for rescue analgesia	30 minutes
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)	90 min
Adverse effect	nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol	90 minutes

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Semir Nouira, Professor, University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Acute pain; Diclofenac; Magnesium Sulfate; Renal colic; Lidocain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Infant, Newborn, Diseases; Renal Colic; Emergencies; 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; Anti-Inflammatory Agents; 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; Diclofenac; Magnesium Sulfate
• Other Study ID Numbers: UMonastir2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No