Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control in renal colic patients.
Design
In this study, all patients who have the criteria for entering the study. First, their pain levels are measured by the VAS index. After the injection of the drug for 20 minutes, the patient's pain again is record.
All data such as demographic information such as age, sex, and clinical information such as renal colic history, post-injection drug complications are collected using a pre-designed questionnaire, and then analyzed by the spss21 program..
Settings and conduct
The location of the educational hospitals of Iran University of Medical Sciences and patients and analysts are blind to prescription drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 80
Inadequate IV access.
History of allergy or hypersensitivity to any component of ibuprofen, ketorolac,
Less than 18 years of age or over 80years
Use of analgesics less than 8 hours prior to admission in ED.
Pregnant.
Recent history of chronic opioid use.
Intervention groups
consist of Ibubrphem goup that Compared to Intravenous Ketorolac for Pain Control in renal colic patients.
Main outcome variables
How is Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control in renal colic patients?
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038276N1
Registration date:2018-02-22, 1396/12/03
Registration timing:registered_while_recruiting
Last update:2018-02-22, 1396/12/03
Update count:0
Registration date
2018-02-22, 1396/12/03
Registrant information
Name
amir noyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 2186
Email address
a.noyani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control in Patient with renal colic pain
Public title
Efficacy of Pain Relief of Ketorolac Compared to Ibuprofen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old and under 80 year s old
Renal colic pain
Exclusion criteria:
Sensitivity to drug
No IV access
Pregnant woman
Opium user
Analgestic drug use
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
The population of each group is 35, 35 of whom are in the therapeutic group of intravenous ketorolac and 35 are Intraintravenous Ibuprophen
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups based on the number of paired cases and the case file
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the patients and data analyst blind to type of drug and data analyst take data as group A and B
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat
City
Tehran
Province
Tehran
Postal code
354-14665
Approval date
2017-11-14, 1396/08/23
Ethics committee reference number
IR.IUMS.FMDREC1396.9411307007
Health conditions studied
1
Description of health condition studied
RENAL COLIC
ICD-10 code
N22
ICD-10 code description
Calculus of urinary tract in diseases classified elsewhere
Primary outcomes
1
Description
Renal colic pain score
Timepoint
At first and after 20 minutes of injection
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients undergoing injection of intravenous Ibubrophen with a single dose of 75mgr
Category
Treatment - Drugs
2
Description
Control group: In this group, patients undergoing injection of intravenous Ketorolac with a single dose of 40mgr
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Seyyed Ahmad Borghey
Street address
Sattarkhan
City
Tehran
Province
Tehran
Postal code
354-14665
Phone
+98 21 6651 6001
Email
a.noyani@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hasan Shaker
Street address
Sattarkhan
City
Tehran
Province
Tehran
Postal code
354-14665
Phone
+98 21 6651 6000
Email
a.noyani@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
20
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
Iran University of Medical Sciences
Full name of responsible person
Seyyed Ahmad Borghey
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Sattarkhan
City
Tehran
Province
Tehran
Postal code
354-14665
Phone
+98 21 6651 6000
Email
a.noyani@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ahmad borgheey
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
354-14665
Phone
+98 216656001
Email
a.noyani@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amir Noyani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emam Hosein
City
Shahrood
Province
Tehran
Postal code
354-14665
Phone
+98 23 3234 2000
Email
a.noyani@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available