The aim of this study is to investigate the comparison of Ibuprofen, Ketorolac, and Morphin on acute renal colic pain relief.
Design
A clinical trial with a control group, with parallel and randomized groups.
Settings and conduct
In this randomized clinical trial, patients suspicious of renal colic referred to the emergency department of Ahvaz were evaluated. Diagnosis of the disease is based on the pain of the flank, history of the disease and the presence of blood in the urine that confirmed by ultrasound or spiral abdominal CT. Patients were selected from the emergency department of Imam Khomeini and Golestan hospitals in Ahwaz, Iran. Patients' pain was measured by Visual analogue scale (VAS) and patients with a pain score of more than 3 were evaluated based on this system.
The patients were randomly divided into 3 groups receiving morphine, ketorolac and ibuprofen.
The pain was recorded at different time points
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed acute renal colic by computed tomography scan or urinary tract ultrasound.
Exclusion criteria: History of the heart, renal or hepatic disease and fever
Intervention groups
Group A received 800 mg I.V Ibuprofen during 5 minutes
Group B received 30 mg I.V Ketorolac
Group C treated by 5 mg I.V Morphine sulfate
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170423033599N2
Registration date:2018-10-22, 1397/07/30
Registration timing:registered_while_recruiting
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3161
Email address
yazdani.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of Ibuprofen, morphine, and ketorolac in patients with renal colic
Public title
Comparison of ibuprofen, morphine, and ketorolac in the treatment of kidney pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed acute renal colic by computed tomography scan or urinary tract ultrasound
Exclusion criteria:
Pregnancy
Patients with history of Heart, renal or hepatic disease
Fever
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
183
Actual sample size reached:
183
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapour University of Medical Sciences Ethical Committee
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.AJUMS.REC.1395.554
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
Baseline, 15, 30, 60 and 120 minutes after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: An intravenous single dose of 800 mg will be injected within 5 minutes
Category
Treatment - Drugs
2
Description
Intervention group2 : A single dose of 30 mg intravenous Ketorolac will be injected
Category
Treatment - Drugs
3
Description
Intervention group3: A single dose of 5 mg intravenous morphine will be injected
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Parivash Yazdani
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455136472
Phone
+98 21 8670 5503
Email
Ali.khossravi70@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parivash Yazdani
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455136472
Phone
+98 21 8670 5503
Email
Ali.khossravi70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz University of Medical Sciences
Full name of responsible person
Parivash Yazdani
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455128422
Phone
+98 61 3374 3079
Email
Ali.khossravi70@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Parivash Yazdani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
64661823172
Phone
+98 61 3374 3079
Email
ali.khossravi70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parivash Yazdani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
64661823172
Phone
+98 61 3374 3079
Email
ali.khossravi70@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parivash Yazdani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
64661823172
Phone
+98 61 3374 3079
Email
ali.khossravi70@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available