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IRCT20230722058883N1 IRCT 2023-08-22 Tehran University of Medical Sciences The effect of ondansetron administration on pain reduction The effect of ondansetron administration on pain reduction after appendectomy surgery 2014-03-21 anticipated 76 Complete https://irct.ir/trial/71603 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 patients are randomized blocked in two groups of 40 according to the table provided (attached table) from the Random Allocation software. The way to do it is that first, ondansetron and placebo are coded by a knowledgeable person so that their nature is unknown to the prescriber. Ondansetron and placebo are provided by a knowledgeable person to a person who is unaware of the nature of the codes, and they are prescribed by the same person. It is done by an uninformed person, measuring the effect of the drug on the variables is also done by another person who is not aware of the type of drug used in each patient, Blinding description: Double-blinding means that neither the study subjects nor the observers (researchers) know who is in which group. The way to do it is to first code the ondansetron drug and the placebo by a knowledgeable person so that their nature for The prescribing person is unknown. Ondansetron and placebo are presented by a person who is aware of the nature of the codes to a person who is unaware of the nature of the codes, and their prescription is done by the same person who is unaware, and the effect of the drug on the variables is measured by another person who knows the type of drug used in each patient. It is not aware. 3 Reduction of post-surgical pain. Intervention 1: In the operating room, standard patient monitoring including EKG, pulse oximetry, blood pressure every 5 minutes, capnography and the patient's initial symptoms are recorded. Immediately before premedication for the group under study, 2 mg/cc of ondansetron is used as an injection in normal saline. Intervention 2: For the control group, cc2 of distilled water in normal saline is injected as a placebo. Premedication is done using intravenous fentanyl 2 micrograms per kilogram of body weight and midazolam 0.03 mg/kg. 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 None
public Peyman Mirghaderi
Poursina st.
Tehran Iran (Islamic Republic of) 1417653761 +98 913 794 8357 mirghaderi76@gmail.com Tehran University of Medical Sciences scientific Peyman Mirghaderi
Poursina st.
Tehran Iran (Islamic Republic of) 1417653761 +98 913 794 8357 mirghaderi76@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients with appendectomies without complications the absence of disorders such as cardiorespiratory, liver, and neurological diseases the absence of drug addiction patients with A.S.A. 1,2 were included in the study. 18 years 60 years Both patients with complications after appendectomy drug addiction mental diseases such as bipolar disorder, schizophrenia, and depression patients with blood pressure less than 90/60 or more than 180/110 that require medical intervention. K35 Acute appendicitis Rehabilitation Placebo In the operating room, standard patient monitoring including EKG, pulse oximetry, blood pressure every 5 minutes, capnography and the patient's initial symptoms are recorded. Immediately before premedication for the group under study, 2 mg/cc of ondansetron is used as an injection in normal saline. For the control group, cc2 of distilled water in normal saline is injected as a placebo. Premedication is done using intravenous fentanyl 2 micrograms per kilogram of body weight and midazolam 0.03 mg/kg. According to the visual analog scale (VAS) pain scale, how much pain reduction was experienced in the case group compared to the controls. Timepoint: Before appendectomy and after. Method of measurement: visual analog scale (VAS) pain. Tehran University of Medical Sciences Approved 2015-03-21 Ethics committe of Hormozgan University of Medical Sciences and Healthcare Services Poursina St. Tehran Tehran Iran (Islamic Republic of)