Clinical trial NCT05653401: Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.
Official title: Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Colic
Keywords: Acute pain
Renal colic
Magnesium Sulfate
Lidocain
Diclofenac
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
timeFrame: 30 minutes
Secondary outcomes:
measure: The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
timeFrame: 90 min
measure: Adverse effect
timeFrame: 90 minutes
measure: The need for additional analgesics at 30 minutes after protocol start to relieve the pain
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References: