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

NCT05653401 | Completed Phase 2

• 1 other identifier: UMonastir2022
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Colic

Keywords

Acute pain; Renal colic; Magnesium Sulfate; Lidocain; Diclofenac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  90 min

• Adverse effect

  90 minutes

• The need for additional analgesics at 30 minutes after protocol start to relieve the pain

  30 minutes

Study Arms (3)

Magnesium Sulfate

ACTIVE COMPARATOR

Intravenous Magnesium Sulfate combined to Diclofenac

Drug: Magnesium sulfate and diclofenac

Lidocaine

ACTIVE COMPARATOR

Intravenous lidocaine combined to Diclofenac

Drug: Lidocain and diclofenac

Diclofenac

ACTIVE COMPARATOR

Intramuscular Diclofenac alone

Drug: Placebo and diclofenac

Interventions

Magnesium sulfate and diclofenac 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

Also known as: Intravenous Magnesium Sulfate combined to Diclofenac

Magnesium Sulfate

Lidocain and diclofenac 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.

Also known as: Intravenous Lidocain combined to Diclofenac

Lidocaine

Placebo and diclofenac 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.

Also known as: Diclofenac alone with placebo ( serum saline )

Diclofenac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

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

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Renal Colic; Acute Pain

Interventions

Magnesium Sulfate; Diclofenac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Semir Nouira, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind study

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: November 20, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)