Evaluating and comparing effect of aminophylline, ketamine and paracetamol on reduction of postoperative pain after deep vitrectomy surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 240 patients. Randomization allocation software is used for randomization and patients are also divided into 4 parallel groups including ketamine, acetaminophen, aminophylline and placebo.
Settings and conduct
In this clinical study, patients are divided into 4 parallel groups including ketamine, acetaminophen, aminophylline and placebo, and the pain intensity in the study groups are evaluated up to 24 hours after surgery. The anesthesiologist, data collector and statistical analyzer are blinded about the type of groups. It is noteworthy that the drugs are prepared in the same containers and the same shape.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients undergoing deep vitrectomy, aged between 40 to 80 years and American society of anesthesiologists physical status I or II.
Exclusion criteria: cardiac arrest during surgery and any complications that are required an alteration in anesthesia methods.
Intervention groups
Intervention group 1: About 0.15mg/kg of ketamine with 100 cc of normal saline are injected intravenous 20 minutes before surgery ending.
Intervention group 2: About 1g of acetaminophen with 100 cc of normal saline are injected intravenous 20 minutes before surgery ending.
Intervention group 3: About 3 mg/kg of aminophylline with 100 cc of normal saline are injected intravenous 20 minutes before surgery ending.
Intervention group 4: 100 cc of normal saline is injected intravenous 20 minutes before surgery ending.
Main outcome variables
Postoperative pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052523N1
Registration date:2021-10-07, 1400/07/15
Registration timing:registered_while_recruiting
Last update:2021-10-07, 1400/07/15
Update count:0
Registration date
2021-10-07, 1400/07/15
Registrant information
Name
Keyvan Ghadimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8060
Email address
keyvanghadimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preemptive effect of aminophylline, ketamine and paracetamol on pain intensity after deep vitrectomy surgery
Public title
The effect of aminophylline, ketamine and paracetamol on pain severity after emptying of vitreous
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 40 to 80 years
American society of anesthesiologists (ASA) physical status I or II
Undergoing deep vitrectomy
Exclusion criteria:
Cardiac arrest during surgery
Any complications that required an alteration in anesthesia methods
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the patients is provided with a particular number by Random Allocation software allocated them to an intervention group. Each patient is provided with a particular number. Cases with numbers corresponded for 4*k are allocated to ketamine group, those with numbers corresponded for 4*k+1 are allocated to acetaminophen, those with numbers corresponded for 4*k+2 are allocated to the aminophylline group and those with numbers corresponded for 4*k+3 are allocated to placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are divided into groups 1 to 4 and no one knows the type of groups except the manager. Patients are received the same number of drugs based on group number, as well as anesthesiologist, data collector and statistical analyzer are blinded of grouping types. It is noteworthy that the drugs are prepared in the same containers and the same shape that the blinding is done completely.
Placebo
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 Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.MUI.REC.1396.3.876
Health conditions studied
1
Description of health condition studied
Disorders of vitreous
ICD-10 code
H43
ICD-10 code description
Disorders of vitreous body
Primary outcomes
1
Description
Postoperative pain
Timepoint
Arrival to recovery and then at 15 and 30 minutes, 2, 4, 8, and 24 after entry to recovery unit
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 minutes before surgery ending, about 0.15mg/kg of ketamine with 100 cc normal saline is injected intravenously.
Category
Prevention
2
Description
Intervention group: 20 minutes before surgery ending, about 1g of acetaminophen with 100 cc normal saline is injected intravenously.
Category
Prevention
3
Description
Intervention group: 20 minutes before surgery ending, about 3 mg/kg of aminophylline with 100 cc normal saline is injected intravenously
Category
Prevention
4
Description
Control group: 20 minutes before surgery ending, 100 cc normal saline is injected intravenously.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Darioush Moradi Farsani
Street address
Modares St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 2034
Email
dmoradi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mozhgan Mortazavi
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mortazavi@med.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
Iman Nikkhoo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
imannikkhoo1907@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Nikkhoo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
imannikkhoo1907@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Keyvan Ghadimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Hezar Jarib St.
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8060
Fax
Email
keyvanghadimi@yahoo.com
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
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
The data of the present study are provided by the relevant professor and in the case of publishing new and related studies are provided
When the data will become available and for how long
Following the publication of the article in an international journal, the data will be accessible
To whom data/document is available
Residents of anesthesiology who have a new proposal in this regard with the similar professor
Under which criteria data/document could be used
Only for publication of a new article with the relevant professor
From where data/document is obtainable
With the relevant anesthesiologist
What processes are involved for a request to access data/document
Following a call or an email to the relevant professor