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IRCT20201113049375N1 IRCT 2021-09-10 Islamic Azad University The effect of injectable Acetaminophen and Magnesium Sulfate on pain after Maxillofacial surgery. Comparison of the effect of Apotel and Magnesium Sulfate analgesics on pain and Pethidine dose after Maxillofacial surgery. 2021-09-23 anticipated 60 Complete https://irct.ir/trial/58091 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: A prospective, randomized, double-blind, single type and individual clinical trial using sealed envelopes. The total number of drugs (30 Apoteles and 30 Magnesium Sulfate) is sealed in white bags and then randomly placed from 1 to 60 pieces. We do not know what medicine is in which package. Numbers 1 to 60 are written on the cards. The patient selects the card. The anesthesiologist reads the number on the card and select the envelope which has the number on the card, opens the envelope during the surgery and is informed of the type of medicine, writes the number on the patient's form, and writes the code and type of medicine in the patient's file. The file is archived in the surgery department so that the researcher enters the type of medicine at the end of the sampling by referring to the file. In this way, we will have two groups of 30 people that were randomly divided, Blinding description: Drugs are sealed in coded envelopes and delivered to the anesthesiologist. In any surgery, the anesthesiologist and surgeon are aware of the type of medication. The anesthesiologist records the code in the patient file. Blinding patients is in such a way that explanations about the study are given and consent is given, but they are unaware of the type of prescription drug. The clinical caregiver and researcher is a person who is unaware of the type of prescription drug (is blind). While caring for the patient, the nurse and resident are unaware of the type of drug (blind). Only the drug code is mentioned in the form. Finally, the researcher enters the patient's file, based on the drug code, enters the type of drug in each patient's form. 2-3 Post surgical pain control in Maxillofacial surgery. Intervention 1: Intervention group 1: Patients receiving Apotel one gram, Acetaminophen 50 ml, Alborz daroo, One gram is injected to the patient one hour before the end of surgery. Intervention 2: Intervention group 2: Magnesium sulfate 50 mg / kg, Shahid Ghazi Tabriz, 50 mg / kg is injected to the patient one hour before the end of surgery. Yes - There is a plan to make this available What will be shared: Comparison of the effect of Apotel and Magnesium Sulfate on pain and dose of Pethidine in patients with maxillofacial surgery When: 6 months after publication of thesis To whom: Oral and Maxillofacial Surgeons, Plastic Surgeons and ENT Surgeons Conditions: The data is fully available to individuals to perform the desired analysis Where to obtain: To receive the Thesis , refer to the research site of Azad University at https://ris.iau.ac.ir/ How to obtain: Registration in the research site of Azad University Comments:
public Mahdi Khalili
Unite 20, No 2/1, Yaghout Buil, Yaghout Alley, Hoseini Alley, Saba Blvd, Andarzgou St, Tehran
Tehran Iran (Islamic Republic of) 1933865311 +98 21 2268 6549 khalilimahdi67@gmail.com Islamic Azad University scientific Mahdi Khalili
Unit 20, No 2/1, Yaghout Build, Yaghout Alley, Hoseini Alley, Saba Blvd, Andarzgou St
Tehran Iran (Islamic Republic of) 1933865311 +98 21 2268 6549 khalilimahdi67@gmail.com Islamic Azad University Iran (Islamic Republic of) Men and Women 45 - 18 years American Society of Anesthesiologists (ASA) Class I and II anesthesia Patients have informed consent to study Candidate for Maxillofacial surgery No Maxillofacial reoperation or Emergency or Multiple trauma 18 years 45 years Both Having any severe drug allergies . . . . . . Be addicted to drugs, alcohol and psychedelics Severe liver and kidney disease or severe anemia Serious heart rhythm disorder and severe arrhythmia Chronic treatment with corticosteroids or calcium channel blockers or NSAIDs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients receiving Apotel one gram, Acetaminophen 50 ml, Alborz daroo, One gram is injected to the patient one hour before the end of surgery. Intervention group 2: Magnesium sulfate 50 mg / kg, Shahid Ghazi Tabriz, 50 mg / kg is injected to the patient one hour before the end of surgery. Pain rate in Apotel group. Timepoint: Measurement of pain after injection of Apotel in patients with Maxillofacial surgery in recovery, 4, 8 and 12 hours after recovery. Method of measurement: Visual Analogue Scale questionnaire. Pain rate in Magnesium Sulfate group. Timepoint: Measurement of pain after injection of Magnesium Sulfate in patients with Maxillofacial surgery in recovery, 4, 8 and 12 hours after recovery. Method of measurement: Visual Analogue Scale questionnaire. Need for use of opioid in the Apotel group. Timepoint: Measurement of the need for opioid use after Apotel injection in patients with Maxillofacial surgery in recovery, 4, 8 and 12 hours after recovery. Method of measurement: Depending on the patient's needs for 30 mg of Pethidine at a time. Need for use of opioids in the group of Magnesium Sulfate. Timepoint: Measurement of the need for opioid use after magnesium sulfate injection in patients with Maxillofacial surgery in recovery, 4, 8 and 12 hours after recovery. Method of measurement: Depending on the patient's needs for 30 mg of Pethidine at a time. Islamic Azad University Approved 2019-04-21 Ethics Committee of the School of Dentistry - Tehran Islamic Azad University of Medical Sciences. No. 2/1، Yaghoot Building, Yaghoot Alley, Hosseini Alley, Saba Blvd، Andarzgoo St، Tehran .. Tehran Tehran Iran (Islamic Republic of)