Renal Colic
Conditions
Keywords
acute pain, Renal colic, Diclofenac, Lidocain, Magnesium sulfate
Brief 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.
Detailed 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.
Interventions
DRUGDiclofenac
Intramuscular injection of 75mg / 3ml of Diclofenac solution
DRUGMagnesium Sulfate
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
DRUGLidocaine
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Double blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success evaluated at 30 minutes after drug administration. | 30 minutes | we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration. |
| Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration. | 90 minutes | elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes | 30 minutes | The proportion of patients achieving a drop in initial pain score of at least 3 |
| Adverse effect | 90 minutes | eg 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 |
Countries
Tunisia
Outcome results
None listed