Comparison of the effect of Apotel and Ketorolac before surgery on pain and the need for narcotics after abdominal surgery during the first 24 hours after surgery.
Determining the effect of Apotel and Ketorolac before surgery on pain and the amount of narcotic consumption after abdominal surgery during the first 24 hours after surgery.
Design
A double-blind randomized clinical trial study, phase 3, with two groups (a group of Apotel 1 gram intravenously and a group of Ketorolac 30 mg intravenously) with a sample size of 64 people in each group
Patients are divided into two groups by online random number table.
Settings and conduct
The location of this clinical trial study is in Bo Ali Hospital, Tehran. The drugs were divided A/B by the head of the surgery department (a group of Apotel 1 g intravenously and a group of Ketorolac 30 mg as a honey injection). Due to the double-blindness of the study, the doctor and the patient will not know which group the patient is in. Medicines were administered to the patients upon entering the operating room and in the recovery room.
Participants/Inclusion and exclusion criteria
Electiveness of action
ASA1,2 (American Society of Anesthesiologists)
Age 18-65 years
Signing a personal consent form to enter the study
Non-use of drugs, alcohol, cigarettes and psychotropic drugs
Exclusion criteria:
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
The length of the operation is more than 4 hours
Intervention groups
One hour before the operation, one group received 1 gram of Apotel intravenously and one group received 30 mg of Ketorolac as a honey injection
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230911059408N1
Registration date:2023-10-13, 1402/07/21
Registration timing:prospective
Last update:2023-10-13, 1402/07/21
Update count:0
Registration date
2023-10-13, 1402/07/21
Registrant information
Name
Samira Sohrabpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 1015
Email address
samirasohrabpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Apotel and Ketorolac before surgery on pain and the need for narcotics after abdominal surgery during the first 24 hours after surgery.
Public title
Comparación de los efectos de Apotel y Ketorolac antes de la cirugía sobre el dolor y la cantidad de narcóticos necesarios después de la cirugía abdominal
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elective surgery
ASA1,2 (American Society of Anesthesiologists)
Age 18-65 years
Signing a personal consent form to enter the study
No abuse of drugs, alcohol, cigarettes and psychotropic drugs
Exclusion criteria:
Loss of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
The length of the operation more than 4 hours
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:
128
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were randomly divided into two groups A and B. The randomization method was performed as follows:
First, a list of random numbers was generated using Excel software (using the Random Number Generation option).
Then, these numbers were randomly assigned to patients.
To maintain randomness, random numbers were generated and distributed by an individual independent of the study.
In this study, block randomization method was used. In this method, patients were divided into small blocks and then each block was randomly assigned to one of two groups. The following method was used to randomize 128 patients into two groups of 64:
First, the patients were divided into 16 blocks of 8 people (each block includes 4 people from group A and 4 people from group B, and each block will have 8 words from A and B).
After that, in each block, people enter the groups randomly. Randomization will be done inside each block based on the table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is a double-blind clinical trial (in order to make this study double-blind, the drugs used for the patients at the beginning of the study are A/B by the supervisor of the surgery department so that the clinical caregiver and the participants do not know the type of drug received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.IAU.PS.REC.1402.362
Health conditions studied
1
Description of health condition studied
Pain after abdominal surgery
ICD-10 code
T81.9
ICD-10 code description
Unspecified complication of procedure
Primary outcomes
1
Description
Pain
Timepoint
1, 6, 12, 24 hours after the operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One hour before the operation, one group receives 1 gram of Apotel intravenously.
Category
Prevention
2
Description
Control group: One hour before the operation, one group receives a 30 mg ketorolac ampoule as a honey injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Hospital
Full name of responsible person
Mahnaz Narimani Zamanabadi
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Naqipour
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@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
Mahnaz Narimani Zamanabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Narimani Zamanabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
SAMIRA SOHRABPOUR
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
samirasohrabpour@yahoo.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