Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.
- Conditions
- Renal Colic
- Interventions
- Registration Number
- NCT05653401
- Lead Sponsor
- University of Monastir
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- 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 ).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diclofenac Placebo and diclofenac Intramuscular Diclofenac alone Magnesium Sulfate Magnesium sulfate and diclofenac Intravenous Magnesium Sulfate combined to Diclofenac Lidocaine Lidocain and diclofenac Intravenous lidocaine combined to Diclofenac
- Primary Outcome Measures
Name Time Method Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration. 30 minutes 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 )
- Secondary Outcome Measures
Name Time Method The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min) 90 min The proportion of participants with persistent pain (VAS \> 2) at the end of the study (90 min)
Adverse effect 90 minutes nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol
The need for additional analgesics at 30 minutes after protocol start to relieve the pain 30 minutes The need for rescue analgesia
Trial Locations
- Locations (1)
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
🇹🇳Monastir, Tunisia