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IRCT20220517054884N1 IRCT 2023-08-13 The University of Qom Comparison of the effect of methadone and morphine on pain Comparative study Intraoperative methadone and morphin for postoperative pain after rhinoseptoplasty 2022-06-10 anticipated 182 Complete https://irct.ir/trial/63629 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using random block allocation with 4 blocks, which have all four modes A, A, B, B, AA B, B B A A and B A A B A, A B B A, B A A A B, written in 6 cards and The first four patients are randomly grouped. The ward manager takes the patient card out of the bag and the patients are divided into groups by lot. For example, if lottery a A b b The first and second patients are in the first group and the third and fourth patients are in the second group and also for the next four patients, a card is issued again. The anesthesia and injection stage will be performed by an anesthesiologist and The questionnaire is reviewed and completed by an anesthesiologist in the operating room and recovery. Describe how to blind, Blinding description: This study is conducted in a double-blind manner, that is, patients, doctors, caregivers, and statistical analysts will not know about the allocation of groups to reduce bias. In these studies, random assignment is used to allocate patients into two groups: the experimental group and the control group. Researchers and participants are made aware of who is in which group. The study will be conducted in a way that the surgeon, nurses, patients, and the data analyst will not know the type of painkillers injected into the control and intervention groups. Statistical analyst will be selected from outside the treatment team to ensure double-blindness of the study to a large extent. When the patient is not aware of the type of medicine received, the effect of the patient's personal characteristics and psychological aspect on the research results is reduced. Researchers are unaware of which type of painkillers the participant receives. Therefore, the impact of the doctor's judgments in evaluating the clinical symptoms and the patient's pain after surgery is minimized. By using this method, we try to reduce the effect of possible biases in the results (the effect of methadone and morphine in reducing pain). 2-3 Comparison of the effect of methadone and morphine on pain after rhinoseptoplasty surgery. Intervention 1: Intervention group: n the main and studied group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Methadone is administered slowly intravenously half an hour after the start of surgery. Intervention 2: Control group: In this group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Morphine is administered slowly intravenously half an hour after the start of surgery. Yes - There is a plan to make this available What will be shared: It can be published as much as possible When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Results only Where to obtain: Dr. Daman Pak Forqani Hospital How to obtain: Using the email educationmo110@gmail.com Comments:
public Vahid Daman Pak Moghaddam
Forghani Hospital, after the gas station,Azar St
Qom Iran (Islamic Republic of) 3714816335 +98 25 3711 8334 educationmo110@gmail.com The University of Qom scientific Vahid Daman Pak Moghaddam
Forghani Hospital,after the gas station,Azar St.
Qom Iran (Islamic Republic of) 3714816335 +98 25 3721 1301 educationmo110@gmail.com The University of Qom Iran (Islamic Republic of) Candidate patients for rhinoseptoplasty surgery Normal EKG and (no long QT) no limit no limit Both Drug addiction History and psychological illness Patient dissatisfaction History of drug allergy to previous surgeries R52 Acute Pain Treatment - Drugs Treatment - Drugs Intervention group: n the main and studied group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Methadone is administered slowly intravenously half an hour after the start of surgery. Control group: In this group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Morphine is administered slowly intravenously half an hour after the start of surgery. Pain after surgery. Timepoint: The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure pain half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery. Method of measurement: In the study "Comparative study of the effect of methadone and morphine on pain after rhinoseptoplasty surgery" is the method of measuring the outcome variable using a clinical information checklist and the second part is the use of a standard pain intensity questionnaire (Visual Analogue Scale) to determine pain intensity in patients. The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing ‘no pain’ and ‘worst pain imaginable’. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the ‘no pain’ marker is then measured with a ruler giving a pain score out of 10. Hemodynamic variables. (blood pressure, Saturation of Peripheral Oxygen). Timepoint: The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure Hemodynamic variables half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery. Method of measurement: Mercury sphygmomanometer.( for the measurement of blood pressure ).Pulse Oximeter (for the measurement of Saturation of Peripheral Oxygen). Saturation of Peripheral Oxygen. Timepoint: The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure (Saturation of Peripheral Oxygen )half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery. Method of measurement: Pulse Oximeter. Blood pressure. Timepoint: The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure (blood pressure ) half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery. Method of measurement: Mercury sphygmomanometer. In the study "Comparative study of the effect of methadone and morphine on pain after rhinoseptoplasty" the secondary outcome could be "hemodynamic changes". Timepoint: The patient hemodynamics are recorded at the end of the operation, patient extubation and recovery and 1 and 6 hours after surgery. Method of measurement: In this study, using the patient's personal and clinical information checklist, including blood pressure and heart rate and blood oxygen saturation. Qom Medical Sciences Research Deputy The University of Qom Qom Medical Sciences Research Deputy Approved 2022-05-12 Ethics committee of Qom University of Medical Sciences Alley 1, Safashahr St. Qom Ghoum Iran (Islamic Republic of)