Comparison of the analgesic effect of diclofenac suppositories and ketorolac ampoules immediately after cesarean section under general anesthesia
Design
Clinical trial with parallel groups, without blinding, phase 3, on 58 patients in two groups of 29 people.
Settings and conduct
A clinical trial study in Tehran's Boali Hospital in 2024.
There is no such thing as blinding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients undergoing cesarean section
Receive general anesthesia
Exclusion Criteria:
Lack of consent to participate in the study
Age below 18 years
Intervention groups
After cesarean section, the patients of the first group received ketorolac 30 mg intravenously, and the patients of the second group received diclofenac suppositories.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240812062729N1
Registration date:2024-08-21, 1403/05/31
Registration timing:prospective
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Mohammad Givehki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4497 9335
Email address
drgiveki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-20, 1403/06/30
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of diclofenac suppositories and ketorolac ampoules immediately after cesarean section under general anesthesia
Public title
Comparison of the analgesic effect of diclofenac suppositories and ketorolac ampoules immediately after cesarean section under general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing cesarean section
Receive general anesthesia
Exclusion criteria:
Lack of consent to participate in the study
Age below 18 years
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Islamic Azad University of Medical Sciences
Street address
Tehran Islamic Azad University of Medical Sciences, Headquarters Building, Corner of Gol Yakh St., Ayane Blvd., Amir Pabarja St., Golhak Road, Dr. Shariati St., Tehran
City
تهران
Province
Tehran
Postal code
1949635881
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.IAU.TMU.REC.1403.021
Health conditions studied
1
Description of health condition studied
Pain after surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Pain is evaluated by VAS scale during 1, 6, 12 and 24 hours after surgery.
Intervention group: Diclofenac suppository (Diclofenac suppository - Najo 100 mg - Iran Najo Pharmaceuticals - once after surgery)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
buali hospital of tehran
Full name of responsible person
Mohammad Giveh Ki
Street address
Tehran, Emam hosein square, Damavand St.
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsa nia
Street address
Tehran, Dr. Shariati St., Golhak Road, Amir Pabarja St., Ayane Blvd., Corner of Gol Yakh St., Headquarters Building, Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
drgiveki@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Giveh Ki
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran, Dr. Shariati St., Golhak Road, Amir Pabarja St., Ayane Blvd., Corner of Gol Yakh St., Headquarters Building, Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
drgiveki@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Giveh Ki
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran, Dr. Shariati St., Golhak Road, Amir Pabarja St., Ayane Blvd., Corner of Gol Yakh St., Headquarters Building, Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
drgiveki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Giveh Ki
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran, Dr. Shariati St., Golhak Road, Amir Pabarja St., Ayane Blvd., Corner of Gol Yakh St., Headquarters Building, Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
drgiveki@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD