Evaluation of the effect of ibuprofen injection compared to ketorolac injection in improving renal colic pain of out patients after entering the emergency department
Evaluation of the effect of ibuprofen injection compared to ketorolac injection in improving renal colic pain
Design
A parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Random number generation program will be used for randomization.
Settings and conduct
This clinical trial study will be conducted in Golestan Hospital in Ahvaz on patients diagnosed with renal colic.Patients are divided into two groups receiving intravenous ibuprofen or ketorolac, and the pain level is measured at 0, 20, 40, and 60 minutes later.
Participants/Inclusion and exclusion criteria
This study will be conducted on acute renal colic pain caused by kidney stones.The entry criteria include urinalysis test (U/A), ultrasound observation based on the presence of mild and moderate hydronephrosis and a history of similar symptoms, rejection of other differential ultrasound diagnoses, and informed consent and the non-entry criteria includes patients who are candidates for surgical intervention and patients with large stone size.
Intervention groups
The first group received a dose of 800 mg of intravenous ibuprofen in 250 cc of normal saline within 5 minutes to determine the pain intensity at 0, 20, 40, and 60 minutes after the injection.
The second group received a dose of 30 mg of intravenous ketorolac in 250 cc of normal saline within 5 minutes to determine the pain intensity at 0, 20, 40 and 60 minutes after the injection.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230726058930N1
Registration date:2023-10-18, 1402/07/26
Registration timing:registered_while_recruiting
Last update:2023-10-18, 1402/07/26
Update count:0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
Ali Vefagh Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3367 5436
Email address
vefagh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ibuprofen injection compared to ketorolac injection in improving renal colic pain of out patients after entering the emergency department
Public title
Ibuprofen compared to ketorolac in improving renal colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the emergency center with acute renal colic pain caused by kidney stones
Diagnosis of renal colic by an emergency medicine specialist considering clinical examination, urinalysis test (U/A), ultrasound based on the presence of mild and moderate hydronephrosis and rule out other differential diagnoses
Exclusion criteria:
Patients with coagulation disorders
chronic kidney disease (CKD)
severe hydronephrosis
active gastrointestinal bleeding (GIB)
patients who do not respond to treatment up to 30 minutes after drug injection
patients who are candidates for surgical intervention
patients with large stone size
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two intervention groups using randomized block method. For this purpose, blocks of four are prepared and the name of the first intervention is written on two sheets and the name of the second intervention is written on the other two sheets. The sheets are piled up and placed in the container, and one sheet is pulled out for each patient without placing it. Then four sheets are returned to the container and this process is repeated until the sample volume is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.AJUMS.REC.1402.242
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
pain
Timepoint
0, 20, 40, 60 minutes after injection
Method of measurement
Numeric Pain Rating Scale (NRS)
Secondary outcomes
1
Description
blood pressure
Timepoint
After injection of painkillers
Method of measurement
Blood pressure measuring device
2
Description
Shortness of breath
Timepoint
After injection of painkillers
Method of measurement
Borg shortness of breath scale
3
Description
heart beat
Timepoint
After injection of painkillers
Method of measurement
Using a sphygmomanometer
4
Description
nausea
Timepoint
After injection of painkillers
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group: The first group received a dose of 800 mg of intravenous ibuprofen in 250 cc of normal saline within 5 minutes to determine the pain intensity at 0, 20, 40, and 60 minutes after the injection.
Category
Treatment - Drugs
2
Description
Intervention group: The second group received a dose of 30 mg of intravenous ketorolac in 250 cc of normal saline within 5 minutes to determine the pain intensity at 0, 20, 40 and 60 minutes after the injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Ali Vefagh Nematollahi
Street address
Imam Khomeini Medical Education Center Ahvaz- Azadegan St.- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ali Vefagh Nematollahi
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
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
Ali Vefagh nematollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD