Clinical trial NCT03199924: Treatment of Renal Colic in the Emergency Departement (ED).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Colic
Keywords: acute pain
Renal colic
Diclofenac
Lidocain
Magnesium sulfate
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment success evaluated at 30 minutes after drug administration.
timeFrame: 30 minutes
measure: Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration.
timeFrame: 90 minutes
Secondary outcomes:
measure: The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes
timeFrame: 30 minutes
measure: Adverse effect
timeFrame: 90 minutes
measure: The need for additional analgesics at 30 minutes after protocol start to relieve the pain
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Study officials:
affiliation: university of ùmonastir
name: Nouira semir, professor
role: PRINCIPAL_INVESTIGATOR
References: