Determining the effect of piroxicam injection in renal colic patients referred to the emergency department of Imam Khomeini Hospital in Ahvaz in 1402
Design
A clinical trial with a control group.
with double-blind group,
Randomized,
on 176 patients
Settings and conduct
This study is a double-blind and randomized clinical trial. It will be conducted on the population of all patients with renal colic referred to the emergency department of Imam Khomeini Hospital in Ahvaz in 1402. In this study, using the census sampling method, patients with renal colic who referred in the months of February and March 1402 are selected and examined.Sufficient explanations are provided to them regarding the study method and informed consent is obtained.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The criteria for entering the study are willingness and cooperation to participate in the study, suffering from renal colic that has been more than 6 months since the diagnosis of the disease by a specialist doctor.
Exit criteria:
Exclusion criteria are also unwillingness to participate in the study, pregnant women or
Intervention groups
Patients are divided into two groups. In the first group (case), piroxicam ampoule will be prescribed, and in the second group (control), the usual treatment will be done for the patients.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230808059084N1
Registration date:2023-08-20, 1402/05/29
Registration timing:registered_while_recruiting
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Mahsa Bagdeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 729 5540
Email address
mahsa.bagdeli99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
2023-08-06, 1402/05/15
Actual recruitment end date
2023-10-23, 1402/08/01
Trial completion date
2023-12-22, 1402/10/01
Scientific title
Investigating the effect of piroxicam injection in renal colic
Public title
Investigating the effect of piroxicam injection in renal colic
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Desire and cooperation to participate in the study
Suffering from renal colic for more than 6 months from the diagnosis of the disease by the doctor
Exclusion criteria:
Reluctance to participate in the study
Pregnant or lactating women
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
176
Actual sample size reached:
176
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 176 eligible patients will be randomly selected. Then random numbers are created by "Random Allocation" computer software. We randomly divide these numbers into two groups A (first intervention) and B (control). Each number is written on a piece of paper and placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. Then, according to the selected envelope, the patient is assigned to one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
A clinical care prescribes drugs to patients according to which group they are in. The researchers have no knowledge of the type of drug used and collect the results based on the patient's code. Patients are also unaware of the type of medicine they receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
No. 84, Bahnar St
City
Ahvaz
Province
Khouzestan
Postal code
11111111111111111111
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.AJUMS.REC.1402.238
Health conditions studied
1
Description of health condition studied
Patients with renal colic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score on Visual Analogue Scale
Timepoint
Immediately, 15 and 30 minutes after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Vital Signs
Timepoint
Immediately, 15 and 30 minutes after injection
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Patients receiving piroxicam ampoule 40 mg/ml, one dose, once and intramuscularly from Caspian Tamim Company
Category
Treatment - Drugs
2
Description
Control group:Patients receiving ketorolac 30 mg/ml in a single dose, once intramuscularly from exir company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital of ahvaz
Full name of responsible person
Mehsa bagdeli
Street address
No. 84 Bahonar St
City
Ahvaz
Province
Khouzestan
Postal code
11111111111111
Phone
+98 61 3222 2114
Email
mahsa.bagdeli99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maitham Moazi
Street address
No. 84 Bahonar St
City
Ahvaz
Province
Khouzestan
Postal code
11111111111
Phone
+98 930 729 5540
Email
mahsa.bagdli99@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehsa Bagdeli
Position
doctor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
No. 84 Bahonar St
City
Ahvaz
Province
Khouzestan
Postal code
111111111111
Phone
+98 930 729 5540
Email
mahsa.bagdli99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehsa Bagdeli
Position
doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 84 Bahonar St
City
Ahvaz
Province
Khouzestan
Postal code
11111111111
Phone
+98 930 729 5540
Email
mahsa.bagdeli99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mahsa bagdeli
Position
doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 84 Bahonar St
City
ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 930 729 5540
Email
mahsa.bagdeli99@gmail.com
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