Determining the comparative study of the effect of oral magnesium with oral ketorolac on pain after anorectal surgery
Design
randomized parallel Clinical trial with control group, double-blind, , phase 3, on 104 patients. For randomization, the method of randomization of permutation blocks has been used.
Settings and conduct
Patients who are candidates for anorectal surgery at Shahid Beheshti Hospital in Qom, Farabi Limited Surgery Center are divided into two groups: blind and randomized, divided into two intervention groups (receiving magnesium tablets) and the control group (receiving ketorolac tablets). The two drugs are compared to control postoperative pain in patients with anorectal disease.
The clinical trial has two groups of control, parallel, double-blind, randomized, phase 3 on 104 patients. For randomization, the method of randomization of permutation blocks has been used.
Participants/Inclusion and exclusion criteria
Entry requirements; Candidate patients for anorectal surgery and obtaining informed consent and benefiting from the intervention
Exit conditions; Possibility of injury or loss
Intervention groups
The first intervention group (receiving magnesium tablets), the second intervention group (receiving ketorolac tablets)
Main outcome variables
amount of pain (pain score)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120118008769N3
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Seyed Jalal Eshagh Hosseini
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25171181
Email address
j.hosseini@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-01-06, 1399/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Oral Magnesium and Oral Ketorolac on Postoperative Pain after Anorectal Surgery
Public title
Determining the comparative study of the effect of oral magnesium with oral ketorolac on pain after anorectal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are candidates for anorectal surgery If the patient agrees to enter the study
Exclusion criteria:
Inflammatory bowel diseases
Patient dissatisfaction
complicated anal fistula
Patients on sedative drug
below eleven years old
malignancy
Perianal collections
Age
From 11 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the patients, the treatment will be assigned in two groups by the method of randomization of permutation blocks so that the number of samples in the two groups will be equal. For this purpose, four blocks of codes A and B will be made first. The selection of each block will also be random and will be done using dice. This launch will be performed 26 times to complete the assignment of patients to treatment groups. Assignment of treatment to the intervention and control groups will also be on a random basis(coin toss).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly divided into two groups, one group receiving magnesium and the other group receiving ketorolac. ketorolac and magnesium are placed into identical pearls l. Recipients and physicians do not know the type of drug they receive. Only a third person who is not directly involved in the study has the codes of both types of drugs and ID of the patient in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Shahid Lavasani St
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.MUQ.REC.1399.184
Health conditions studied
1
Description of health condition studied
Comparative study of pain after anorectal diseases surgery with two types of ketorolac and magnesium pills
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
amount of pain (pain score)
Timepoint
the 1,3,5,7 day after surgery,
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: Group receiving 250 mg magnesium tablets from Galenus company that the patient takes one tablet daily from 3 hours before the operation for a week
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group 2: The group receiving ketorolac 10 mg tablets from Iran -Hormone company takes one tablet daily from 3 hours before the operation for a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital، farabi day clinics
Full name of responsible person
Seyed Jalal eshaqh Hoseini
Street address
Shahid Beheshti St ,ammar yaser St
City
Qom
Province
Ghoum
Postal code
3719965654
Phone
+98 25 3612 2000
Fax
+98 25 3612 2824
Email
Shahidbeheshti@muq.ac.ir
Web page address
https://bmc.muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Jalal eshaqh Hoseini
Street address
Qom University of Medical Sciences, Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1300
Fax
+98 25 3107 1300
Email
deanofuniversity@muq.ac.ir
Web page address
https://www.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qom University of Medical Science
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Jalal eshaqh Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qom University of Medical Sciences,Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2827
Fax
+98 25 3612 2827
Email
j.hosseini@muq.ac.ir
Web page address
http://dreshagh.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Jalal Eshaq Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qom University of Medical Sciences ,Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
j.hosseini@muq.ac.ir
Web page address
http://dreshagh.ir/
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Farzane Sadat Ghazi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Hospital ,Shahid Beheshti St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2827
Email
Farzanep1994@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
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