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IRCT20180922041084N6 IRCT 2022-03-08 Shiraz University of Medical Sciences The comparison of single dose preemptive intravenous ketorolac and paracetamol on postoperative pain after septorhinoplasty The comparison of single dose preemptive intravenous ketorolac and paracetamol on postoperative pain after septorhinoplasty 2022-04-09 anticipated 108 Complete https://irct.ir/trial/62036 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, using the random blocking method, 108 patients are divided into 12 blocks with a size of 9 into three groups. Blocking will be determined using a random number table of random number generation software. Blocking and sequencing for concealment by a non-involved person in the study will be done by matched opaque envelopes. Paracetamol and a control group of normal saline will be given. Then, based on the obtained blocks and in the order of allocation, the drugs will be given to the patients. This study is a two-way blind, Blinding description: The medicines are prepared by an anesthesiologist who is not aware of how the study is performed and are delivered to the anesthesiologist in the operating room, who is also unaware of how the study is performed. Transferring the patient to the recovery room and handing over the patient to the recovery staff will not give them any information and thus the patient, anesthesia resident and recovery nurse, and the inpatient ward and data analyzer will be blinded to the study. 2-3 rhinoplasty surgery. Intervention 1: Intervention group: To the group receiving ketorolac (36 people) 40 mg of ketorolac (made by Raha company) is injected intravenously in 100cc of normal saline 30 minutes before the operation. Intervention 2: Intervention group: In the group receiving paracetamol (36 people) 1000 mg of paracetamolMade by Samen Company of Mashhad) in 100cc of normal saline is injected 30 minutes before the operation. Intervention 3: Control group: The control group (36 people) is injected with 100 cc of normal intravenous saline 30 minutes before the operation. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy
public Shirin Farrokhyani
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3630 4312 poopanak@gmail.com Shiraz University of Medical Sciences scientific Laleh Dehghan Pisheh
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 lalehdehghan@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Obtaining informed consent Candidate patients for rhinoplasty with age group of 18-50 years and class (ASA) I, II 18 years 50 years Both History of drug allergy to ketorolac and paracetamol History of long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics History of gastrointestinal bleeding, Stomach ulcers or inflammatory bowel disease Diabetes or neuropathic diseases Treatment - Surgery Treatment - Surgery Placebo Intervention group: To the group receiving ketorolac (36 people) 40 mg of ketorolac (made by Raha company) is injected intravenously in 100cc of normal saline 30 minutes before the operation. Intervention group: In the group receiving paracetamol (36 people) 1000 mg of paracetamolMade by Samen Company of Mashhad) in 100cc of normal saline is injected 30 minutes before the operation. Control group: The control group (36 people) is injected with 100 cc of normal intravenous saline 30 minutes before the operation. Post operative pain. Timepoint: At 1, 6, 12 and 24 hours after surgery. Method of measurement: VAS SCORE scoring. Shiraz University of Medical Sciences Approved 2021-11-15 Ethics Committee of Shiraz University of Medical Sciencs Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)