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

Phase 2

Completed

• Conditions: Renal Colic
• Interventions: Drug: Diclofenac; Drug: Lidocaine; Drug: Magnesium Sulfate

• Registration Number: NCT03199924
• Lead Sponsor: University of Monastir

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.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-06-24
• Study First Posted: 2017-06-27
• Primary Completion: 2022-01-01
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous lidocaine combined to diclofenac	Lidocaine	intravenous lidocaine combined to diclofenac
Intravenous Magnesium sulfate combined to Diclofenac	Diclofenac	Intravenous Magnesium sulfate combined to Diclofenac
Intravenous Magnesium sulfate combined to Diclofenac	Magnesium Sulfate	Intravenous Magnesium sulfate combined to Diclofenac
intravenous lidocaine combined to diclofenac	Diclofenac	intravenous lidocaine combined to diclofenac
diclofenac alone	Diclofenac	diclofenac alone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
The need for additional analgesics at 30 minutes after protocol start to relieve the pain	30 minutes	The need for rescue analgesia
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

Trial Locations

Locations (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia; 🇹🇳 Monastir, Tunisia