Protocol summary

Study aim
Determining and comparing the effect of intravenous ibuprofen with intravenous ketorolac in controlling the pain of renal colic patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 76 patients. The rand function of Excel software is used for randomization
Settings and conduct
In this study, we investigate the effect of two NSAIDs, i.e. intravenous ibuprofen and intravenous ketorolac, in renal colic patients referred to the emergency room of Shahid Beheshti Hospital. This study is double-blind, and blinding will be done on the patient and health personnel. It is a clinical trial.
Participants/Inclusion and exclusion criteria
All patients with flank pain (renal colic) and definitive diagnosis of renal colic with imaging findings by non-contrast CT scan or ureteral ultrasound, who are between 18 and 60 years old, are included in this study.Patients with a history of renal failure (CRF), pregnant women, history of liver disease, history of gastrointestinal disease such as active GI bleeding, history of heart disease (HF), history of sensitivity to NSAID are excluded from the study.
Intervention groups
After explaining the objectives of the study to the patients and obtaining informed consent, the patients are divided into two groups using the balanced block random sampling method, each treatment group has 38 people; The first group of 38 people received intravenous ketorolac In both groups, the injection will be done as a single-dose intravenous infusion for 30 minutes with cardiac and respiratory monitoring.
Main outcome variables
drug side effects; The amount of opioid medication needed

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231112060025N1
Registration date: 2023-12-04, 1402/09/13
Registration timing: prospective

Last update: 2023-12-04, 1402/09/13
Update count: 0
Registration date
2023-12-04, 1402/09/13
Registrant information
Name
Atefe Noormohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3661 0690
Email address
atefenrm5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of intravenous ibuprofen and intravenous ketorolac in controlling the pain of renal colic patients .
Public title
"comparative effect of Ibuprofen and ketorolac in Renal colic"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with flank pain (renal colic) who have Definitive diagnosis of renal colic with imaging findings by non-contrast CT scan or ureteral ultrasound. Age between 18 and 60 years
Exclusion criteria:
History of renal failure Pregnant women History of liver disease History of gastrointestinal disease such as active GI bleeding History of heart disease History of sensitivity to NSAID
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
After explaining the objectives of the study to the patients and obtaining informed consent, the patients are divided into two groups using the balanced block random sampling method.Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study ; For the patient and the health personnel (who are responsible for the patient's care), an explanation will be given about both drugs included in the study, and the possible benefits and side effects of each injection will be explained. However, the patient and the health personnel about which of the two drugs will be prescribed; In the two study groups, they will be unaware of which drug; will be injected for the patient; are informed
Placebo
Not used
Assignment
Parallel
Other design features
In both groups, the injection will be done as a single-dose intravenous infusion for 30 minutes with cardiac and respiratory monitoring.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR.MUQ.REC.1401.231

Health conditions studied

1

Description of health condition studied
Renal colice
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic

Primary outcomes

1

Description
Severity of pain caused by renal colic using a numerical scale
Timepoint
at minute zero; 20 minutes after injection; 60 minutes after injection
Method of measurement
VAS scale

Secondary outcomes

1

Description
Time to release and relieve pain
Timepoint
at minute zero; 20 minutes after injection; 60 minutes after injection
Method of measurement
Pre-designed questionnaire

Intervention groups

1

Description
intervention group: including 38 patients; 30 mg intravenous Ketorlak will be administered as a single-dose intravenous infusion for 30 minutes with cardiac and respiratory monitoring.
Category
Treatment - Drugs

2

Description
Intervention group: 38 people intravenous ibuprofen 400 mg will be injected in both groups as a single dose intravenous infusion for 30 minutes along with cardiac and respiratory monitoring.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Atefe Noormohammadi
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
۳۷۱۹۹۶۵۷۵۵
Phone
+98 25 3612 2000
Fax
+98 25 3612 2855
Email
Atefenrm5@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 4011
Fax
Email
rahimalii@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Atefe NoorMohammadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti street
City
Qom
Province
Ghoum
Postal code
۳۷۱۹۹۶۵۷۵۵
Phone
+98 25 3661 0690
Email
Atefenrm5@gmail.com
Web page address
http://bmc.muq.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Shahidi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Beheshti street
City
Qom
Province
Ghoum
Postal code
۳۷۱۹۹۶۵۷۵۵
Phone
+98 25 3612 2000
Fax
+98 25 3612 2855
Email
Atefenrm5@gmail.com
Web page address
http://bmc.muq.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Atefe NoorMohammadi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Street
City
Qom
Province
Ghoum
Postal code
۳۷۱۹۹۶۵۷۵۵
Phone
+98 25 3661 0690
Email
Atefenrm5@gmail.com
Web page address
http://bmc.muq.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
Loading...