Protocol summary

Study aim
Efficacy measurement Of Intravenous Iboprofen Versus Intravenous Ketorolac In Patient Renal Colic Admittend In Emergency Department
Design
In This Research Patients were divided Into 2 groups A&B Acuording to Block Randomise Method &SamplesInclude 240 Renal Colic Patient between 18 to 65 years old.
Settings and conduct
Patients were Checked Pursunt to Reduce Severity of Pain by VAS before Drug Injection &After 15 ,30,60 minuts after that.This Research has been done at Emergency Department of Shohadaie Tajrish Hospital In 1395 ,96 In Tehran.
Participants/Inclusion and exclusion criteria
Admitance Requirement:Every Adults with Renal Colic Diagnosis --Age between 18 to65 years old Non Admitance Requirement:Having Alergy to Ketorolac &Ibuprofen--Non cooperation to DetermineSeverity of Pain by VAS--Pregnancy-- Having background of Heart disease &HTN--Advanced Systemic disease--Malignancy --Chronic Hepatic disease--Having background of Psychiatric &Norologic disease--Use of NSAID at 6 hours ago.
Intervention groups
1--Injection 30 mg Intravenous ketorolac In Group B 2--Injection 800 mg Intravenous Ibuprofen In Group A
Main outcome variables
Curative Success(change of visual analogue scale till at least 3 score) ,Drug Side Effect

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180807040733N1
Registration date: 2018-11-20, 1397/08/29
Registration timing: retrospective

Last update: 2018-11-20, 1397/08/29
Update count: 0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Khaghan Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3449 3136
Email address
drkhaghanmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-01-30, 1396/11/10
Actual recruitment start date
2016-10-01, 1395/07/10
Actual recruitment end date
2018-01-30, 1396/11/10
Trial completion date
2018-01-30, 1396/11/10
Scientific title
Efficacy measurement of Intravenous Ibuprofen versus Intravenous Ketorolac in Patient Renal Colic Admittend in Emergency Department
Public title
Efficacy measurement of Intravenous Ibuprofen versus Intravenous Ketorolac in Patient Renal Colic Admittend in Emergency Department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Every Adalts with Renal Colic Diagnosis Age:Between 18 to 65 years old
Exclusion criteria:
Having Alergy to Ketorolac & Ibuprofen Noncooperation to Determine Severity Of Pain by VAS Peregnancy Having background of Heart disease & Hypertention disease Advanced Systemic disease, Malignancy,& Chronic Hepatic disease Psychiatric & Noroulogic disease Use of NSAID at 6 hours ago
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 240
Actual sample size reached: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Block Random Metod Hase Used In This Reasearch. By A Proffesional Person Guidence In Random Blocks In 6 Size Was Planed By A Proffesional Person Guidence In Clinical Traial Study Metodology .Therefore 40 Prepared Blocks Was Specified According to This Method Pationts Were Divided Into Two Groups Threated By Ibuprofen(group A) & Threated By Ketorolac (group B)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participats, Reasercher, Injector Nurse & Data Collecting liable have been Blind In This Reaserch. The preparation of drug pakage was done by an individual who did not have any role inthe research process at all,30 mg of Ketorolac was poured into 100ml of normal saline &800mg of Ibuprofen was poured in 100ml of another normal saline and placed in two group A & B and prepared For injection.From here on, a Nurse injector who was a person other than the person preparing the pakage ,without any information on the contents of the pack , it only injected serum containing randomized into roups based on grouping alone , patients ,with Full Justification for theirtreatment , after completing informed consent about participation in the research, Without any information about the type of drug ,they were interviewed by the researcher after the end of injection at15,30,&60 minutes. The main investigator on the type of injected drug was blind and unaware, This information was collected and evaluated based on the checklist.Actually, except for the package-maker who had no role in the reseach process,the rest of the group was kept blind until the last stage.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Shahid Beheshti University of Medical Sciences
Street address
7thFloor,BldgNo.2,Shahid Beheshti Univercity Medical School, Arabi St,Velenjak Ave,Tehran Town
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.SBMU.MSP.REC.1395.251

Health conditions studied

1

Description of health condition studied
Renal Colic
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
Curative Success (change of visual analogue scale till atleast 3 score)
Timepoint
Incipience of Stady , 15th minute, 30th, 60th
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaie Tajrish Hospital
Full name of responsible person
Khaghan Mohammadi
Street address
Shohadaie Tajrish Hospital,Shahrdary Ave,Tajrish,Tehran Town
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
+98 21 2291 8001
Email
shohada@sbmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Prof Afshin Zarghi Vice--Chancellor In Reseach Affairs of Shahid Beheshti Univercity
Street address
BldgNo.2, Shahid Beheshti Univercity , Arabi st, Velenjak Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khaghan Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
NO.13, Shahid Frotani Alley, Dehkhoda St, Motahhari Ave, Karaj Town
City
Karaj
Province
Alborz
Postal code
۳۱۴۵۹۵۴۹۱۸
Phone
+98 26 3449 3136
Fax
Email
drkhaghanmohammadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khaghan Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
NO.13, Shahid Frotani Alley, Dehkhoda St, Motahhari Ave, Karaj Town
City
Karaj
Province
Alborz
Postal code
۳۱۴۵۹۵۴۹۱۸
Phone
+98 26 3449 3136
Fax
Email
drkhaghanmohammadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khaghan Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
NO.13, Shahid Frotani Alley, Dehkhoda St, Motahhari Ave, Karaj Town
City
Karaj
Province
Alborz
Postal code
۳۱۴۵۹۵۴۹۱۸
Phone
+98 26 3449 3136
Fax
Email
drkhaghanmohammadi@sbmu.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
Not applicable
Title and more details about the data/document
Final result of reaserch will be published as articl in the Emergency medicinemagazine of the Medical academy of Shahid Beheshty Univercity.
When the data will become available and for how long
This article will be published in the last thre months of 1397 & thence it will be available.
To whom data/document is available
Generally all researchers,specially Emergency medicine phisitians ,Urologists , chemists, students & also pharmaceutic companies can access issues of this research with observation of respective protocol.
Under which criteria data/document could be used
The stady data,s access is passible by getting permission of guidance prof &councillar & accurate observation of principle committec rules &my coordination to ward research &similar studies & check& contrast its results with related studies.
From where data/document is obtainable
You must to refer to prof Saeed Safari master of Emergency medicine of Shahid Beheshty Univercity&my councillor &statistics prof who has complete authority in terms of this issue to receive data &documentsof this research.He presents at Shohadaye Tajrish Hospital on tuesdays & at the research office of the medical school of the medical science academy of Shahid Beheshty Univercity the rest of week.phone number prof safari is 09128251535 , Email address is safari266@gmail.com
What processes are involved for a request to access data/document
One who want to access this research,s data has to send his/her request to prof safari ,s e-mail address transpicuously & at least after time process 2 weeks can receivethis study,s data with prof,s agreement & approval. Email address is :safari266@gmail.com
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