NCT03199924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

5.5 years

First QC Date

May 14, 2017

Last Update Submit

August 9, 2022

Conditions

Renal Colic

Keywords

acute painRenal colicDiclofenacLidocainMagnesium sulfate

Outcome Measures

Primary Outcomes (2)

  • Treatment success evaluated at 30 minutes after drug administration.

    we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration.

    30 minutes

  • Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration.

    elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.

    90 minutes

Secondary Outcomes (3)

  • The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes

    30 minutes

  • Adverse effect

    90 minutes

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

    30 minutes

Study Arms (3)

Intravenous Magnesium sulfate combined to Diclofenac

ACTIVE COMPARATOR

Intravenous Magnesium sulfate combined to Diclofenac

Drug: DiclofenacDrug: Magnesium Sulfate

intravenous lidocaine combined to diclofenac

ACTIVE COMPARATOR

intravenous lidocaine combined to diclofenac

Drug: DiclofenacDrug: Lidocaine

diclofenac alone

ACTIVE COMPARATOR

diclofenac alone

Drug: Diclofenac

Interventions

DiclofenacDRUG

Intramuscular injection of 75mg / 3ml of Diclofenac solution

Also known as: Non Steroidal Anti Inflammatories, Voltaren
Intravenous Magnesium sulfate combined to Diclofenacdiclofenac aloneintravenous lidocaine combined to diclofenac
Magnesium SulfateDRUG

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

Also known as: MgSO4, Sulfamag
Intravenous Magnesium sulfate combined to Diclofenac
LidocaineDRUG

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

Also known as: lignocaine, Xylocaine
intravenous lidocaine combined to diclofenac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent.
  • Age \> 18years.
  • Confirmed renal colic
  • With moderate to severe pain (visual analogic Scale ≥4).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Renal ColicAcute Pain

Interventions

DiclofenacMagnesium SulfateLidocaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Nouira semir, professor

    university of ùmonastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2017

First Posted

June 27, 2017

Study Start

July 1, 2016

Primary Completion

January 1, 2022

Study Completion

July 31, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)