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IRCT20211215053417N1 IRCT 2021-12-20 Yazd University of Medical Sciences 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 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 2021-12-25 anticipated 50 Complete https://irct.ir/trial/60719 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A cross-linking (cxl) surgery. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Faezeh Mazidi Sharafabadi
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
Yazd Iran (Islamic Republic of) 9417612345 +98 35 3183 3220 f.mazidi@stu.ssu.ac.ir Yazd University of Medical Sciences scientific Faezeh Mazidi Sharafabadi
Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology
Yazd Iran (Islamic Republic of) 9417612345 +98 35 3183 3220 f.mazidi@stu.ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) 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. 16 years 35 years Both 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. Treatment - Drugs Treatment - Drugs 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. 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. 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). Yazd University of Medical Sciences Approved 2021-12-20 Ethics committee of yazd University of Medical Sciences Bahonar Square, University Headquarters, Vice Chancellor for Research and Technology Yazd Yazd Iran (Islamic Republic of)