The aim of this study was to evaluate and compare the effect of the meperidine versus apotel-ketorolac combination in reducing post-thoracotomy pain in patients.
Design
A clinical trial with parallel, double-blind, randomized, phase 2 groups on 60 patients. Used for randomization using SPSS software.
Settings and conduct
This study is randomization. The statistical population includes 60 patients who are candidates for right thoracotomy surgery who are referred to Ghaem Hospital. In this study, 60 ASA class 2 patients in the age group of 18 to 70 years were selected as candidates for right thoracotomy surgery and were satisfied with the study.
Participants/Inclusion and exclusion criteria
The study is random. The statistical population includes 60 patients who are candidates for right thoracotomy surgery who are referred to Ghaem Hospital. In this study, 60 ASA class 2 patients in the age group of 18 to 70 years were selected as candidates for right thoracotomy surgery and were satisfied with the study.
Intervention groups
At the beginning of a recovery in the intervention group, one gram of paracetamol and 30 mg of ketorolac as an infusion are prescribed to reduce and control pain. Before the operation, the patient is instructed to express the amount of pain based on the measurement system 1 as the minimum (tolerable) and 10 (unbearable) and during the patient's stay in recovery (average 2 hours) the patient monitors the amount of pain. It is the basis of NRS criteria and vital signs. And repeat control of the control group will be done in case of restlessness of the disease.
Comparing Of Ketrolac Plus Apotel and Meperidine in Decrease Of Pain After Right Thoracotomy
Public title
Comparing Of Ketrolac Plus Apotel and Meperidine in Decrease Of Pain After surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing right thoractomy
Exclusion criteria:
epidural / spinal anesthesia
Patients with a history of addiction
Patients with a history of coagulation disorders and platelets less than one hundred thousand. until the
History of kidney failure
Serum creatinine more than one and a half
Patients with a history of hyperthyroidism
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used as a reliable randomization method. For this purpose, an online website addressed as (https://www.sealedenvelope.com/simple-randomiser/v1/lists) is used to create random blocks with different sizes depending on the total sample and proposed block sizes (4 and 6). Each block content is sealed. One of the block is randomly chosen when a patient refers. The patient is assigned to one of the study arms depending on the block content.
Similarly, after the completion of the first block, the second block is randomly selected and this continues until the last block and the last patient is assigned to the study arms. By assigning the last sheet of the last block, the patients are grouped equally in the two study arms.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of the envelope is that the envelopes will be prepared and printed by one of the members of the research team and random numbers with the help of Randomaize.com site and will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه پزشکی مشهد
Street address
No. A7- 4th amin - amin street- Sajad BLVD
City
مشهد
Province
Razavi Khorasan
Postal code
9187953868
Approval date
2021-09-20, 1400/06/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.397
Health conditions studied
1
Description of health condition studied
surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure,
Timepoint
Immediately after the surgery and in the recovery room at 30 minute intervals
Method of measurement
Mercury sphygmomanometer
2
Description
oxygen saturation
Timepoint
Immediately after the surgery and in the recovery room at 30 minute intervals
Method of measurement
Pulse oximeter
3
Description
transpiration
Timepoint
Immediately after the surgery and in the recovery room at 30 minute intervals
Method of measurement
Ocular observation
4
Description
pain level
Timepoint
Immediately after the surgery and in the recovery room at 30 minute intervals
Method of measurement
Pain questionnaire
Secondary outcomes
1
Description
pulse
Timepoint
30 min
Method of measurement
heart monitoring
Intervention groups
1
Description
Control group: receive meperidine in case of pain ( 0.5 -1mg/kg)
Category
Treatment - Drugs
2
Description
Intervention group:Intravenous ketorolac - paracetamol:At the beginning of recovery in the intervention group, one gram of paracetamol and 30 mg of ketorolac as an infusion are prescribed to reduce and control pain.( the ketrolac is bought from exire co (Iran). And the paracetamol was bought from Unifarma co (Iran)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Allireza Sharifiian
Street address
Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۸۷۹۵۳۸۶۸
Phone
+98 51 3604 9687
Email
Salehiam1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Daneshagah Street -ghoresi buliding
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۸۸۱۳۹۴۴
Phone
+98 51 3841 2081
Email
Salehiam1@mums.ac.ir
Grant name
Dr. Majid Ghayour Mobarhan
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Shariifian
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No A-7 amin 4th- Amin street- Sajad BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۸۷۹۵۳۸۶۸
Phone
+98 51 3604 9687
Email
Salehiam1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza sharifiian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
no 7 amin 4th- amin street sajad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۸۷۹۵۳۸۶۸
Phone
۰۰۹۸۹۱۵۳۶۰۴۹۶۸۷
Email
Salehiam1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohammad Salehi
Position
residence
Latest degree
Medical doctor
Other areas of specialty/work
Biochemistry
Street address
no A7- 4 th amin- amin street - Sajad BLVD
City
mashhhad
Province
Razavi Khorasan
Postal code
۹۱۸۷۹۵۳۸۶۸
Phone
۰۰۹۸۵۱۳۶۰۴۹۶۸۷
Email
Salehiam1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
6 months after publication
To whom data/document is available
professor and student of university
Under which criteria data/document could be used
Mashhad medical student
From where data/document is obtainable
No 7- 4th Amin- Amin street - Sajad BLVD-
What processes are involved for a request to access data/document