Comparison of the effect of indomethacin as a non-steroidal anti-inflammatory drug and acetaminophen for postoperative pain in patients undergoing cross-linking (cxl) surgery
The aim of this study was to compare the effect of using a single dose of indomethacin 75 mg non-steroidal anti-inflammatory drug (SIDS) and a single dose of 500 mg acetaminophen tablets on postoperative pain in patients referred to Shahid Sadoughi Hospital in Yazd for collagen cross-linking surgery. Will be done
Design
The present study is a clinical trial with a control group, with a parallel group, double-blind, randomized on 50 patients and divided into two groups using a table of random numbers.
Settings and conduct
It is performed in Shahid Sadoughi Hospital in Yazd. Group A receives indomethacin tablets before surgery and group B receives 500 mg acetaminophen tablets. It is given from surgery and the researcher's colleague is aware of which drugs A and B are included. Using the Visual Aid Scale Questionnaire and the number of analgesics used during the 24 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria included male and female patients between 16 and 35 years of age, including unlikely consecutive sampling of significant keratoconus with reading k greater than 47D and central corneal thickness greater than um400.Exclusion criteria for people with a history of eye surgery, acute corneal hydrops, dense corneal ectasia, corneal opacity, any history of NSAID allergies, or the use of topical / systemic anti-inflammatory drugs are excluded within two weeks prior to surgery. Also, patients with a BMI of less than 18.5 and more than 30 are excluded from the study due to changes in the use of analgesic doses for pharmacological effects.
Intervention groups
In this study, patients are divided into groups A and B. Group A receives 75 mg of slow-release indomethacin tablets one hour before surgery and group B receives 500 mg of acetaminophen tablets one hour before surgery.
Main outcome variables
The effect of anti-inflammatory drugs, the amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211215053417N1
Registration date:2021-12-20, 1400/09/29
Registration timing:prospective
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
faezeh mazidi sharafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3830 2343
Email address
f.mazidi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-25, 1400/10/04
Expected recruitment end date
2022-01-24, 1400/11/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of indomethacin as a non-steroidal anti-inflammatory drug and acetaminophen for postoperative pain in patients undergoing cross-linking (cxl) surgery
Public title
Comparison of the effect of indomethacin as a non-steroidal anti-inflammatory drug and acetaminophen for postoperative pain in patients undergoing cross-linking (cxl) surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients between 16 and 35 years of age included unlikely consecutive sampling of significant keratoconus with readings greater than 47 d and central corneal thickness greater than 400um.
Exclusion criteria:
patients with a history of eye surgery, acute corneal hydrops, dense corneal ectasia, corneal opacity, any history of NSAID allergies, or the use of topical / systemic anti-inflammatory drugs are excluded from the study within two weeks prior to surgery. Also, patients with a BMI of less than 18.5 and more than 30 are excluded from the study due to changes in the use of analgesic doses for pharmacological effects.
Age
From 16 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. The aim of comparing the effect of using a single dose of non-steroidal anti-inflammatory drug indomethacin 75 mg slow release and a single dose of acetaminophen 500 mg on postoperative pain in patients referred to Shahid Sadoughi Hospital in Yazd for collagen cross-linking surgery will be done. This study is a double-blind clinical trial in which two drugs are given to a patient before surgery in bottles labeled with drugs A and B by a research colleague And the research partner is aware of what drugs A and B contain. Also, before surgery, the patient is explained that the judgment used for this study is a single dose of 75 mg slow-release indomethacin tablets or a single dose of 500 mg acetaminophen tablets, but the patient does not know which of these two drugs to take before surgery. Uses. It should be noted that these two drugs are similar in form and the patient is not able to distinguish between the two drugs in terms of appearance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
9417612345
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.SSU.SPH.REC.1400.122
Health conditions studied
1
Description of health condition studied
cross-linking (cxl) surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Visual Pain Scale (VAS) Score
Timepoint
Visual Pain Scale (VAS) questionnaire is determined at 4 hours after surgery and the number of analgesics used during 24 hours after surgery.
Method of measurement
Visual Pain Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One hour before surgery, they receive a single dose of 75 mg slow-release indomethacin tablets made in Iran and Aria Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: One hour before surgery, they receive a single dose of 500 mg acetaminophen tablets, which are made in Iran and Shafa Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Faezeh Mazidi Sharafabadi
Street address
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
9417612345
Phone
+98 35 3183 3220
Email
f.mazidi@stu.ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Mazidi Sharafabadi
Street address
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
94176123454
Phone
+98 35 3183 3220
Email
f.mazidi@stu.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Mazidi Sharafabadi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
9417612345
Phone
+98 35 3183 3220
Email
f.mazidi@stu.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Mazidi Sharafabadi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
9417612345
Phone
+98 35 3183 3220
Email
f.mazidi@stu.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faezeh Mazidi Sharafabadi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
9417612345
Phone
+98 35 3183 3220
Email
f.mazidi@stu.ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available