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IRCT20220803055606N1 IRCT 2022-09-20 Shahid Beheshti University of Medical Sciences Effect of dexamethasone and ketorolac on edema and ecchymosis after rhinoplasty Comparison of the effect of Dexamethasone and Ketorolac, separately on post rhinoplasty edema and ecchymosis 2022-07-11 anticipated 60 Complete https://irct.ir/trial/65191 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups of dexamethasone or ketorolac with a ratio of 1:1. Block randomization will be performed via computer generated codes by using sealedenvelope website (www.sealedenvelope.com). Briefly, one of the researchers who is not involved in the treatment and assessment phases, prepares paired blocks (each block size=4) and 20 sequence lists, and put the assigned sequence in the same sealed envelopes. Then, according to randomization, the envelopes will be given to the therapist researcher. 2 Rhinoplasty. Intervention 1: In intervention group 1, patients will receive intravenous dexamethasone (8 mg, IRANHORMONE), one dose before and three doses every 8 hours after surgery. Intervention 2: Patients in interventional group 2, will receive one dose (30 mg) of Ketorolac (IRAN HORMONE) intramuscularly after induction of anesthesia and will receive two doses of 30 mg every 8 hours. 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 further information
public Dr. Bijan Nagibzadeh
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 info@drnaghibzadeh.com Shahid Beheshti University of Medical Sciences scientific Dr. Bijan Nagibzadeh
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 info@drnaghibzadeh.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18-45 years Patients who are candidate for rhinoplasty 18 years 45 years Both History of previous nose surgery Need for septoplasty Need osteotomy Heart failure Drug abuse History of hypersensitivity to non-steroidal anti-inflammatory drugs History of ulcerative gastrointestinal disease Diabetes Asthma Pulmonary failure Renal failure Nasal fracture Treatment - Drugs Treatment - Drugs In intervention group 1, patients will receive intravenous dexamethasone (8 mg, IRANHORMONE), one dose before and three doses every 8 hours after surgery Patients in interventional group 2, will receive one dose (30 mg) of Ketorolac (IRAN HORMONE) intramuscularly after induction of anesthesia and will receive two doses of 30 mg every 8 hours. Severity of peri-ocular edema based on standard 4-grade scoring tool. Timepoint: 7 days after the operation. Method of measurement: standard 4-grade scoring tool. Severity of peri-ocular ecchymosis based on standard 4-grade scoring tool. Timepoint: 7 days after the operation. Method of measurement: standard 4-grade scoring tool. Shahid Beheshti University of Medical Sciences Approved 2021-09-21 Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)