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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03199924
Other study ID # COL-NEPHR
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 1, 2016
Est. completion date July 31, 2022

Study information

Verified date August 2022
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Magnesium (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 a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic. Objective of study : The aim of this study is to 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 emergency department with renal colic and whether it can reduce opioid consumption.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Diclofenac
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Magnesium Sulfate
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
Lidocaine
intravenous injection of 10ml lidocaine 1% solution administered over 2 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 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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