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IRCT20130304012695N9 IRCT 2021-04-30 Tehran University of Medical Sciences Reduction of pain of renal transplantation surgeries Evaluation of postoperative analgesic effect of Intra muscular injection of methadon after induction of anesthesia in Renal Transplantation Surgery. 2021-04-30 anticipated 70 Complete https://irct.ir/trial/55243 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To randomize patients with inclusion criteria, block balanced randomization is used. Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room, Blinding description: Participants: since patients are not aware of the type of study drug at the time of anesthesia induction they were blind about the group to which they were allocated. Those who evaluate the outcome: the assistant who records the results in this study does not know the type of group. Data collection officials: the person who analyzes the data also does not know the type of participating groups. 2-3 Condition 1: Abdominal Acute Pain after renal transplant surgery. Condition 2: Postoperative stress and agitation. Intervention 1: Intervention group: after induction of anesthesia 5mg methadone intranuscularly was injected .After extubation, incidence and severity of abdominal pain and degree of agitation and total amount of analgesic consumption in in recovery and ward and 24 hours after surgery are evaluated. Intervention 2: Control group: after induction of anesthesia 5mg morphine intranuscularly was injected .After extubation, incidence and severity of abdominal pain and degree of agitation and total amount of analgesic consumption in in recovery and ward and 24 hours after surgery are evaluated. Yes - There is a plan to make this available What will be shared: All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared. When: Starting access after accepting by a valid scientific journal and publishing it To whom: For academic researchers and in the field of science Conditions: All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned. Where to obtain: Mohammad Reza Khajavi How to obtain: The applicant can request the type of files by email. khajavim@tums.ac.ir Comments:
public Mohammadreza Khajavi
Sina Hospital Imam Khomeini
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences scientific Mohammadreza Khajavi
Sina Hospital Imam Khomeini
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Renal failure candidate for renal transplant 20 years 55 years Both History of drug addiction and methadone use History of neural or psychiatric drugs History of asthma or seizure Prolonged QT interval in EKG R10.0 F43.0 Acute abdomen Acute stress reaction Treatment - Devices Treatment - Drugs Intervention group: after induction of anesthesia 5mg methadone intranuscularly was injected .After extubation, incidence and severity of abdominal pain and degree of agitation and total amount of analgesic consumption in in recovery and ward and 24 hours after surgery are evaluated Control group: after induction of anesthesia 5mg morphine intranuscularly was injected .After extubation, incidence and severity of abdominal pain and degree of agitation and total amount of analgesic consumption in in recovery and ward and 24 hours after surgery are evaluated Incidence and severity of abdominal pain. Timepoint: post extubation in recovery and 6,12,18 and 24 hours after surgery in ward. Method of measurement: Visual Analogue Scale. Severity of postoperative agitation. Timepoint: Ramsy sedation Scale. Method of measurement: Post extubation in recovery and 6,12,18 and 24 hours after surgery in ward. Tehran University of Medical Sciences Approved 2021-04-21 Ethics Committee of the School of Medicine, Tehran University of Medical Sciences Sina hospital, Hasan Abad Sq., Emam Khomeni st. Tehran Tehran Iran (Islamic Republic of)