Treatment of Renal Colic in the Emergency Departement (ED).

University of Monastir

Status and phase: Completed; Phase 2

Conditions: Renal Colic

Treatments: Drug: Magnesium Sulfate; Drug: Lidocaine; Drug: Diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT03199924

COL-NEPHR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 3 patient groups

Intravenous Magnesium sulfate combined to Diclofenac

Active Comparator group

Description:

Intravenous Magnesium sulfate combined to Diclofenac

Treatment:

Drug: Diclofenac

Drug: Magnesium Sulfate

intravenous lidocaine combined to diclofenac

Active Comparator group

Description:

intravenous lidocaine combined to diclofenac

Treatment:

Drug: Diclofenac

Drug: Lidocaine

diclofenac alone

Active Comparator group

Description:

diclofenac alone

Treatment:

Drug: Diclofenac