Skip to main content
OpenTrials
Completed

NCT Number: NCT05653401

Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.

Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Monastir, 5000, Tunisia

About this study

Magnesium Sulfate (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 as a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.

Objective of study:

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 ED with renal colic and whether it can reduce opioid consumption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent.
  • Age between 18 and 65 years .
  • Diagnosis of renal colic made by an emergency medicine physician, based on history and clinical findings, and urine analysis or by identifying the urinary tract stone using ultrasonography or radiologic imaging including CT scan .-With moderate to severe pain (visual analogic Scale ≥5 ).

Exclusion criteria

  • known renal or hepatic dysfunction, use of NSAIDs and/or opioids within 6 h before presentation
  • history of bleeding diathesis, history of peptic ulcer disease or gastrointestinal hemorrhage,
  • History of cardiac arrhythmia, severe coronary artery disease, seizures, presence of any peritoneal sign, altered mental status, and anticoagulant medication or coagulation disorders.
  • Use of any analgesics or spasmolytics in the previous 4 hours before admission, hemodynamic instability, and prior known allergy to lidocaine or morphine .
  • Pregnant women , Breast feeding
  • Allergy or contraindications to NSAIDs, lidocaine or MgSO 4

Treatment and study plan

Magnesium sulfate and diclofenac

Drug

Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 1 g of Magnesium Sulfate solution diluted in 10 ml of saline solution administered over 2 to 4 minutes

Other names: Intravenous Magnesium Sulfate combined to Diclofenac

Lidocain and diclofenac

Drug

Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 10 ml of Lidocaine 1% solution administered over 2 to 4 minutes.

Other names: Intravenous Lidocain combined to Diclofenac

Placebo and diclofenac

Drug

Intramuscular injection of 75 mg of Diclofenac solution and 10 ml Intravenous injection of serum saline ( as a Placebo Comparator ) administered over 2 to 4 minutes.

Other names: Diclofenac alone with placebo ( serum saline )

Primary outcomes

  1. Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.

    Time frame: 30 minutes

    Significant pain reduction as at least a 50% drop of VAS Score of the initial pain score at 30 min after analgesia administration ( Drop VAS Score is in favour of analgesic treatment efficiency )

Secondary outcomes

  1. The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)

    Time frame: 90 min

    The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)

  2. Adverse effect

    Time frame: 90 minutes

    nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol

  3. The need for additional analgesics at 30 minutes after protocol start to relieve the pain

    Time frame: 30 minutes

    The need for rescue analgesia

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.