Evaluation of the preventive effects of aminophylline, plasil and paracetamol on the pain intensity after strabismus surgery
Design
Clinical trial with control group and three parallel groups double blinded randomized
Settings and conduct
This is a double-blinded clinical trial, performed on 120 patients underwent strabismus correction surgery in Feiz hospital, Isfahan. Patients were randomized into 4 groups: Aminophylline, plasil, paracetamoland placebo. After surgeries, patients were assessed with Visual Analogue Scale (VAS) to evaluate their pain. Also Hemodynamic parameters, extubation and recovery time after surgeries were also evaluated.
Participants/Inclusion and exclusion criteria
inclusion criteria were: absence of any history of allergic reactions to Aminophyllinem paracetamol or plasil, absence of history of chronic pain more than 6 months, abbsence of taking analgesics, paracetamol, aminophylline or plasil in 24 hours before the study and filled written informed consent.
Intervention groups
Group 1 taking Paracetamol. Group 2 taking Plasil. Group 3 taking Aminophylline. Control group taking no medication
Main outcome variables
Pain intensity after strabismus surgery meaningfully different; arterial blood pressure meaningfully different; heart rate meaningfully different.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150106020588N6
Registration date:2019-07-28, 1398/05/06
Registration timing:retrospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Darioush Moradi Farsani
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 5555
Email address
dmoradi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-07, 1396/02/17
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-08-03, 1396/05/12
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
2018-01-15, 1396/10/25
Scientific title
Evaluation of the preventive effects of Aminophylline, Plasil and Paracetamol on the pain intensity after strabismus surgery
Public title
Evaluation of the preventive effects of Aminophylline Plasil and Paracetamol on the pain intensity after strabismus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
abbsence of taking analgesics, paracetamol, aminophylline or plasil in 24 hours before the surgery
Filled written informed consent
Exclusion criteria:
Any background of allergy to Aminophylline Plasil and Paracetamol
Reporting chronic pain prolonged more than 6 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
parients were randomized by using computer softwares and randomly entered to the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher was blind and wasn't aware of which patient belongs to which group.
The data collectors ware blind and weren't aware of which patient belongs to which group.
The participants were bling and weren't aware of their own groups
Placebo
Not 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
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2017-05-25, 1396/03/04
Ethics committee reference number
IR.MUI.1396.3.440
Health conditions studied
1
Description of health condition studied
strabismus
ICD-10 code
H50.1
ICD-10 code description
Exotropia
Primary outcomes
1
Description
Intensity of pain after strabismus surgery
Timepoint
entering the recovery, 30 , 60 mins and 2 , 4,8,16,24 hours after entering to recovery
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Control group: no intervention
Category
N/A
2
Description
Intervention group: 0.1 mg per kg Metoclopiramide slow IV 15 mins befor surgery ends.
Category
Treatment - Drugs
3
Description
Intervention group: 3mg per kg Aminophylline 15 mins before surgery ends
Category
Treatment - Drugs
4
Description
Intervention group: 1g Paracetamol IV infusion 15 mins before surgery ends
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Dr Daryoush Moradi
Street address
Feiz hospital, modarres street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196711111
Phone
+98 31 3445 2034
Email
behrouzesf91@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Research deputy, Isfahan University of Medical Sciences, Hezarjarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196711111
Phone
+98 31 3792 8091
Email
behrouzesf91@ymail.com
Web page address
https://research.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
Darioush Moradi Farsani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Scienses, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8196711111
Phone
+98 31 3625 5555
Fax
Email
dmoradi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Scienses, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8196711111
Phone
+98 31 3625 5555
Fax
Email
dmoradi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Scienses, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8196711111
Phone
+98 31 3625 5555
Fax
Email
dmoradi@med.mui.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
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
All data
When the data will become available and for how long
6 months after publishing
To whom data/document is available
Researchers
Under which criteria data/document could be used
Statistics analysis
From where data/document is obtainable
Email of scientific author
What processes are involved for a request to access data/document