The effect of magnesium sulfate with ketorolac compared to morphine with ketorolac on reducing pain in patients with renal colic at 20, 40 and 60 minutes after drug administration
Design
This randomized, double-blind trial is conducted on 70 patients with renal colic. Patients will be randomly assigned to 35 populated groups
Settings and conduct
This study will be performed in the emergency department of Al-Zahra Hospital. 70 patients with colic will be selected by simple random sampling. Then they will be divided into two groups by computer randomization. Patients in the first group will receive magnesium sulfate with ketorolac and patients in the second group will receive morphine with ketorolac.
The drugs will be prepared before the intervention and will be placed in syringes of the same shape and coded with labels a and b. Therefore, the researcher and the patient will not know the type of drug.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patients with acute renal colic over the age of 16 years and consent to participate in the study.
exclusion criteria: morphine or ketorolac susceptibility, renal dysfunction, injection of analgesic in the past 6 hours
bleeding diseases, warfarin use, drug addiction, and Pregnancy and breastfeeding
Intervention groups
Magnesium Sulfate with ketorolac Group: Patients with renal colic in this group will be received magnesium sulfate with a dose of 30 mg/kg and ketorolac 30 mg intravenously.
Morphine with ketorolac Group: Patients with renal colic in this group will be received morphine with a dose of 5mg and ketorolac 30 mg intravenously.
Main outcome variables
Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160130026253N4
Registration date:2020-05-20, 1399/02/31
Registration timing:prospective
Last update:2020-05-20, 1399/02/31
Update count:0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
Alireza Abootalebi Ghahnavieh
Name of organization / entity
Isfahan University of medical sciences, Emergency Department, Isfahan, I. R, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
a_abootalebi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of magnesium sulfate with ketorolac and morphine with ketorolac on pain in patients with colic
Public title
The effect of magnesium sulfate with ketorolac and morphine with ketorolac on relief pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of renal colic
Satisfaction of patients or their companions to enter the study
Exclusion criteria:
Allergy to morphine or ketorolac
Renal dysfunction
injection of analgesic in the past 60 hours
bleeding diseases
Use of warfarin
Drug addiction
Pregnancy and breastfeeding
Age
From 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
All patients will be randomly assigned to two intervention groups using the computer randomization method based on the sequence of numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Prescribing medication and recording the patient's pain score will be performed by a resident who is unaware of the type of medication and the patients will be unaware of the type of medication prescribed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Azadi Square.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-09, 1398/12/19
Ethics committee reference number
IR.MUI.MED.REC.1398.665
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Renal colic
Primary outcomes
1
Description
Pain Score
Timepoint
20, 40, 60 minutes after drug administration
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Side effects
Timepoint
60 minutes after drug administration
Method of measurement
Observation
Intervention groups
1
Description
Patients with renal colic in this group will be received magnesium sulfate at a dose of 30 mg/kg and ketorolac at a dose of 30 mg in a volume of 100 cc at 15 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: Patients with renal colic in this group will be received morphine at a dose of 5mg and ketorolac at a dose of 30 mg in a volume of 100 cc at 15 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Al-Zahra Hospital
Full name of responsible person
Alireza Abootalebi
Street address
Department of emergency medicine, Al-Zahra hospital, Soffeh Boulevard, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Abootalebi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
no.125 Ahmadi Alley. North Sheikhsadogh St.
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3620 2085
Email
a_abootalebi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Abootalebi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3620 2085
Email
a_abootalebi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Abootalebi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No.125, Ahmadi Alley, North Sheykh Sadough, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3661 9729
Email
A_abootalebi@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
A_abootalebi@yahoo.com
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.