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

University of Monastir

Status and phase: Completed; Phase 2

Conditions: Renal Colic

Treatments: Drug: Magnesium sulfate and diclofenac; Drug: Placebo and diclofenac; Drug: Lidocain and diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT05653401

UMonastir2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

800 participants in 3 patient groups

Magnesium Sulfate

Active Comparator group

Description:

Intravenous Magnesium Sulfate combined to Diclofenac

Treatment:

Drug: Magnesium sulfate and diclofenac

Lidocaine

Active Comparator group

Description:

Intravenous lidocaine combined to Diclofenac

Treatment:

Drug: Lidocain and diclofenac

Diclofenac

Active Comparator group

Description:

Intramuscular Diclofenac alone

Treatment:

Drug: Placebo and diclofenac