Renal Colic Clinical Trial
Official title:
Intravenous Magnesium Sulfate Combined to Diclofenac Versus Intravenous Lidocaine Combined to Diclofenac Versus Diclofenac Alone in the ED Treatment of Renal Colic. A Randomized Double Blind Study.
Verified date | August 2022 |
Source | University of Monastir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid consumption.
Status | Completed |
Enrollment | 600 |
Est. completion date | July 31, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Informed consent. - Age > 18years. - Confirmed renal colic - With moderate to severe pain (visual analogic Scale =4). Exclusion Criteria: - Current regular use of analgesics, anticonvulsants, or antidepressants. - Analgesia taken within 24 hours . - Renal disorder with a low glomerular filtration rate (< 60ml/min) - Neuromuscular disorder. - Severe cardiac disease. - Pregnant women - Contraindication to one of the protocol treatment - Inability of the patient to cooperate - Allergy to NSAID or lidocaine. |
Country | Name | City | State |
---|---|---|---|
Tunisia | Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia | Monastir |
Lead Sponsor | Collaborator |
---|---|
University of Monastir |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment success evaluated at 30 minutes after drug administration. | we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration. | 30 minutes | |
Primary | Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration. | elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%. | 90 minutes | |
Secondary | The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes | The proportion of patients achieving a drop in initial pain score of at least 3 | 30 minutes | |
Secondary | Adverse effect | eg 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 |
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