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Effectiveness of Intravenous Lidocaine, Intravenous Magnesium Sulfate and Intravenous Ketorolac for Pain Management In Patient With Renal Colic

Protocol summary

Study aim
Comparison of the effectiveness of intravenous lidocaine, intravenous magnesium sulfate, and intravenous ketorolac in controlling pain in patients with renal colic.
Design
Phase 3 clinical trial with control and intervention groups with parallel groups, double-blind, randomized using a simple random number table on 100 patients
Settings and conduct
This study will be performed in the emergency department of Imam Reza Hospital in Tabriz, East Azerbaijan province. The patients were randomly divided into 3 groups, and in the control group, intravenous ketorolac, in the first intervention group, intravenous magnesium sulfate, and in the second intervention group, intravenous lidocaine will be administrated. Pain score before drug administration and 5, 10, 15 and 30 minutes after will be checked and recorded using the VAS tool. The patient and the outcome examiner will be blinded to the study groups.
Participants/Inclusion and exclusion criteria
People between 18 and 65 years old with acute renal colic will be included in the study. Patients with a history of kidney failure, liver disease, heart disease, asthma, or a history of allergy to the drugs used in this study, and pregnant patients will not be included in the study.
Intervention groups
In the control group, 30 mg of ketorolac will be injected intravenously and 500 cc of normal saline will be prescribed as a placebo. In the magnesium sulfate group, 2 grams of magnesium sulfate in 500 cc of normal saline will be injected to the patient and 10 cc of normal saline will be prescribed as a placebo. In the lidocaine group, the amount of 1.5 mg of lidocaine per kilogram of body weight will be injected to the patient and 500 cc of normal saline will be prescribed as a placebo.
Main outcome variables
Pain score at 5, 10, 15 and 30 minutes after drug administration using VAS tool

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090923002496N13
Registration date: 2023-06-21, 1402/03/31
Registration timing: prospective

Last update: 2023-06-21, 1402/03/31
Update count: 0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Intravenous Lidocaine, Intravenous Magnesium Sulfate and Intravenous Ketorolac for Pain Management In Patient With Renal Colic
Public title
Lidocaine and magnesium sulfate in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute renal colic
Exclusion criteria:
History of kidney disease History of cardiac disease History of hepatic disease Pregnant patients History of asthma History of allergy to any of the drugs in study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into three groups in a simple and individual way using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants will be blinded to their group by using placebo. The examiner of the results will also be blinded to the category in which the patient is located.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee of Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.TBZMED.REC.1402.005

Health conditions studied

1

Description of health condition studied
Renal colic
ICD-10 code
N20-N23
ICD-10 code description
Urolithiasis

Primary outcomes

1

Description
Pain score in 5th, 10th, 15th and 30th minutes after drug administration
Timepoint
5, 10, 15, 30 minutes
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intravenous Lidocaine
Category
Treatment - Drugs

2

Description
Intervention group: intravenous magnesium sulfate
Category
Treatment - Drugs

3

Description
Control group: intravenous ketorolac
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr.Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
Email
soleimanpourh@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 1335 2078
Email
soleimanpourh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 1335 2078
Email
soleimanpourh@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All individual data from the study will be accessible after de-identification.
When the data will become available and for how long
2024
To whom data/document is available
Data will be available for all interested researchers
Under which criteria data/document could be used
Data will be available for use in other studies. researchers can ask for data of this study by sending email to dr. Hassan Soleimanpour
From where data/document is obtainable
Dr. Hassan Soleinampour soleimanpourh@tbzmed.ac.ir
What processes are involved for a request to access data/document
By sending an e-mail request, the documents can be received within a period of about two weeks.
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