Comparison of the effect of propofol and ketorolac effect in renal colic
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
A Comparative Study on Effect of Ketorolac and Propofol in Improvement of Patients with Renal Colic in Emergency Department of Ayatollah Mousavi Hospital in Zanjan
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients aged 18 to 65 suspected of acute renal colic referring to the emergency department of Ayatollah Mousavi Hospital in Zanjan, whose condition was confirmed by one of the methods of KUB, CT-Scan, IVP and ultrasound;
Consent to participate in the scheme.
Exclusion criteria:
Dissatisfaction with the patient to participate in the study
Age younger than 18 years old; age more than 65 years
History of hypersensitivity to pofolum or ketorolac;
History of allergy to eggs and soy;
Pregnancy or doubt about it;
Breastfeeding;
History of receiving a home remedy in the last 4 hours;
Heart failure; liver and kidney;
Patients have a change in consciousness;
Patients with mental disorder
Drug addiction;
Cancellation of the patient's participation in the study;
Intervention groups
Intervention group:
Patients Receiving intravenous propofol with 0.8-mg/kg
Control group: Patients receiving Ketorolac
Main outcome variables
Determine the analgesic effect of propofol in patients with renal colic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180124038488N1
Registration date:2020-02-22, 1398/12/03
Registration timing:retrospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Farshad Deilami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 0753
Email address
farshaddaylami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intra-venous propofol versus ketorolac for creating analgesia in patiant with renal colic
Public title
Comparison effect of intra-venous propofol versus ketorolac for creating analgesia in patiant with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 to 65 y/o
agreement to participate
Exclusion criteria:
pregnancy
allergy to propofol or egg
addiction
Unwillingness to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into the two group by table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and researcher are blinded to the prescribed prescription
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zanjan University of Medical Sciences
Street address
gavazang
City
zanjan
Province
Zanjan
Postal code
0
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.ZUMS.REC.1398.070
Health conditions studied
1
Description of health condition studied
Urolithiasis
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Pain score in Visual Analogue Scale
Timepoint
BEFORE INJECTION AND 30 , 60 AFTER INJECTION
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
vital sign
Timepoint
each 15 min until one hour
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Patient group receiving Propofol
Category
Treatment - Drugs
2
Description
Control group:patients receiving Ketorolac
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi hospital
Full name of responsible person
Dr farshad deilami
Street address
Gavazang, School of Medicine Zanjan University of Medical Sciences Zanjan
City
Zanjan
Province
Zanjan
Postal code
43333
Phone
+98 24 3400 0000
Email
Farshaddaylami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
DR ALIREZA SHOGHLI
Street address
AZADI BLV, School of Medicine Zanjan University of Medical Sciences
City
ZANJAN
Province
Zanjan
Postal code
45154
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Farshad Deilami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No 350, third east ave, ghods, zanjan
City
Zanjan
Province
Zanjan
Postal code
475847564
Phone
+98 24 3347 0753
Fax
Email
Farshaddaylami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farshad Deilami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No 350, third east ave, ghods, zanjan
City
Zanjan
Province
Zanjan
Postal code
475847564
Phone
+98 24 3347 0753
Fax
Email
Farshaddaylami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
farshad deilami
Position
Emergency medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
qods
City
Zanjan
Province
Zanjan
Postal code
4733130000
Phone
+98 24 3313 0000
Email
farshaddaylami@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