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

NCT ID: NCT05653401

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2023-08-01

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.

Conditions

Renal Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Magnesium Sulfate

Intravenous Magnesium Sulfate combined to Diclofenac

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate and diclofenac

Intervention Type: DRUG

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

Lidocaine

Intravenous lidocaine combined to Diclofenac

Group Type: ACTIVE_COMPARATOR

Lidocain and diclofenac

Intervention Type: DRUG

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.

Diclofenac

Intramuscular Diclofenac alone

Group Type: ACTIVE_COMPARATOR

Placebo and diclofenac

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Intravenous Magnesium Sulfate combined to Diclofenac; Intravenous Lidocain combined to Diclofenac; Diclofenac alone with placebo ( serum saline )

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semir Nouira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

UMonastir2022

Identifier Type: -

Identifier Source: org_study_id