Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05653401
Other study ID # UMonastir2022
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 20, 2022
Est. completion date August 1, 2023

Study information

Verified date September 2023
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 800
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magnesium sulfate and diclofenac
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 diclofenac
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 diclofenac
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.

Locations

Country Name City State
Tunisia Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Monastir

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) 90 min
Secondary Adverse effect nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol 90 minutes
Secondary The need for additional analgesics at 30 minutes after protocol start to relieve the pain The need for rescue analgesia 30 minutes
See also
  Status Clinical Trial Phase
Withdrawn NCT01685658 - Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations Phase 4
Completed NCT01349244 - Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic N/A
Recruiting NCT04169555 - "Point of Care" Ultrasound and Renal Colic N/A
Completed NCT04160520 - Pramipexole and Morphine for Renal Colic Phase 1/Phase 2
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Completed NCT01979042 - Urinary Markers for Unilateral Kidney Obstruction N/A
Completed NCT03865004 - Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment Phase 4
Completed NCT03706404 - Renal Colic Fast Track Pathway in the Emergency Department. N/A
Completed NCT03638921 - 35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER Phase 2
Completed NCT03665753 - Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED Early Phase 1
Not yet recruiting NCT05150899 - Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm
Recruiting NCT03790514 - Heat Wrap for Renal Colic N/A
Completed NCT00646061 - Pain Control in Renal Colic Phase 1
Not yet recruiting NCT02782273 - Morphine Versus Ketorolac in Renal Colic Phase 4
Completed NCT01352676 - Limit Computed Tomography (CT) Scanning in Suspected Renal Colic
Not yet recruiting NCT06412900 - Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence
Not yet recruiting NCT06342648 - Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic N/A
Recruiting NCT03137498 - Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department Phase 4
Recruiting NCT01742689 - Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic Phase 3
Completed NCT01546701 - Buprenorphine in Acute Renal Colic Pain Management Phase 4