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

University of Monastir800 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

800

Conditions

Renal Colic

Interventions

Magnesium sulfate and diclofenacDRUG

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

Lidocain and diclofenacDRUG

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.

Placebo and diclofenacDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Monastir, Tunisia

Outcomes

Primary Outcomes

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 )

Time frame: 30 minutes

Secondary Outcomes

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)

Time frame: 90 min

Adverse effect

nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol

Time frame: 90 minutes

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

The need for rescue analgesia

Time frame: 30 minutes

Data from ClinicalTrials.gov

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