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IRCT20230709058726N1 IRCT 2023-07-29 Esfahan University of Medical Sciences Investigating the effect of prednisolone on the pain after tonsillectomy Comparative study of the effect of oral prednisolone on postoperative tonsillectomy pain in adults 2023-07-23 anticipated 60 Complete https://irct.ir/trial/71186 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Post-tonsillectomy pain. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data and their analysis in an unidentifiable manner When: The access period starts 6 months after the results are published To whom: Researchers Conditions: Further analysis can be done with coordination and permission. Where to obtain: Dr. Amin Shayan, by sending an email to amin.shayan068@gmail.com How to obtain: The requester will be answered within one working week after sending the email Comments:
public Nezamodin Berjis
Kashani
Isfahan Iran (Islamic Republic of) 8179994348 +98 916 392 4802 berjis@med.mui.ac.ir Esfahan University of Medical Sciences scientific Nezamodin Berjis
Kashani
Isfahan Iran (Islamic Republic of) 8179994348 +98 916 392 4802 berjis@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having tonsil stones or chronic tonsil infection or tonsil tumor or nocturnal snoring requires tonsillectomy Consent to participate in the study 18 years 65 years Both Having diabetes Having hypertension Using corticosteroids Using immunosuppressives Treatment - Drugs Placebo 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. 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. 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. Esfahan University of Medical Sciences Approved 2020-11-15 Ethics committee of Medical School Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)