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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intravenous Magnesium sulfate combined to Diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Magnesium Sulfate

Intervention Type DRUG

intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes

intravenous lidocaine combined to diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Lidocaine

Intervention Type DRUG

intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes

diclofenac alone

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Interventions

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Diclofenac

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Intervention Type DRUG

Magnesium Sulfate

intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes

Intervention Type DRUG

Lidocaine

intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes

Intervention Type DRUG

Other Intervention Names

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Non Steroidal Anti Inflammatories Voltaren MgSO4 Sulfamag lignocaine Xylocaine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No