Determining and comparing the effect of oral prednisolone on pain after tonsillectomy with suture in adults
Design
A clinical trial with a control group, with a parallel group, three blinded, randomized, phase 3 on 60 patients, random numbers are used for randomization.
Settings and conduct
This study is carried out in Kashani and Al-Zahra Hospital, Isfahan. The patient, drug delivery and analyzer are blinded. Patients are selected from tonsil surgery candidates and after obtaining informed consent, patients are divided into two groups. The intervention group and the control group are examined for one week in terms of post-operative pain level.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Tonsil stone
Chronic tonsil infection
Suspicion of tonsil tumor
Nocturnal snoring requires tonsillectomy
Non-entry criteria
Diabetes
High blood pressure
Corticosteroid drug use
Taking immunosuppressive drugs
Intervention groups
In the intervention group, for one week, patients are treated with a 0.5 mg/kg prednisolone tablet and one 500 mg acetaminophen tablet every 6 hours. In the control group, patients take placebo and one 500 mg acetaminophen tablet with the above prescription (similar to the other group).
Main outcome variables
Post-operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230709058726N1
Registration date:2023-07-29, 1402/05/07
Registration timing:registered_while_recruiting
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
nezamodin berjis
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 991 6574
Email address
berjis@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of oral prednisolone on postoperative tonsillectomy pain in adults
Public title
Investigating the effect of prednisolone on the pain after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having tonsil stones or chronic tonsil infection or tonsil tumor or nocturnal snoring requires tonsillectomy
Consent to participate in the study
Exclusion criteria:
Having diabetes
Having hypertension
Using corticosteroids
Using immunosuppressives
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After the patients meet the criteria of entering the study, their group will be determined by the random code that is given to them.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Each patient received him/her drugs by showing the code to a pharmacist, who was blind to codes and only gave the sealed drug pocket assigned to each code, containing prednisolone tab or placebo, to the patient. The placebo tab was designed precisely as the prednisolone tab and contained starch. Control group patients receive as many placebo tabs as if it was prednisolone.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical School Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
8176664348
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.MUI.MED.REC.1399.715
Health conditions studied
1
Description of health condition studied
Post-tonsillectomy pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-operative pain
Timepoint
Daily for a week
Method of measurement
A Visual Analog Scale (VAS) is a measurement tool used to assess subjective experiences, such as pain. It typically consists of a straight line with endpoints representing the extremes of the experience being measured, and the participant is asked to mark their level of experience on the line.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients are treated with 0.5 mg/kg prednisolone and one 500 mg acetaminophen tablet every 6 hours for one week.
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients take placebo + one 500 mg acetaminophen tablet with the above instructions (similar to the other group). Placebo looks similar to prednisolone tablets and contains starch. The placebo is produced in Isfahan Faculty of Pharmacy of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Amin Shayan
Street address
kashani St.
City
Isfahan
Province
Isfehan
Postal code
8179997653
Phone
+98 31 3233 0091
Email
amin.shayan068@gmail.com
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Amin Shayan
Street address
soffeh St.
City
Isfahan
Province
Isfehan
Postal code
8176661854
Phone
+98 31 3792 2000
Email
amin.shayan068@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar jerib ave
City
Isfahan
Province
Isfehan
Postal code
8179994523
Phone
+98 31 3792 3060
Email
askari@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
Nezamodin Berjis
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani
City
Isfahan
Province
Isfehan
Postal code
8179994348
Phone
+98 916 392 4802
Fax
Email
berjis@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nezamodin Berjis
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani
City
Isfahan
Province
Isfehan
Postal code
8179994348
Phone
+98 916 392 4802
Fax
Email
berjis@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nezamodin Berjis
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani
City
Isfahan
Province
Isfehan
Postal code
8179994348
Phone
+98 916 392 4802
Fax
Email
berjis@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data and their analysis in an unidentifiable manner
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers
Under which criteria data/document could be used
Further analysis can be done with coordination and permission.
From where data/document is obtainable
Dr. Amin Shayan, by sending an email to amin.shayan068@gmail.com
What processes are involved for a request to access data/document
The requester will be answered within one working week after sending the email