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IRCT20150106020588N7 IRCT 2020-05-26 Esfahan University of Medical Sciences effect of metoclopramide, pethidine and ketamine on the postoperative pain The effect of subcutaneous injection of metoclopramide, pethidine and ketamine on the postoperative pain after inguinal hernia repair under general anesthesia 2018-04-04 anticipated 104 Complete https://irct.ir/trial/44623 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 104 patients are needed for this study, 26 in each of the four groups. We will prepare 104 envelopes, containing either number 1, 2, 3, or 4. The envelopes will be shuffled randomly. The envelopes will be then handed out for each patient to an anesthesiologist. The anesthesiologist will then apply the subcutaneous injections based on the code in the envelopes, Blinding description: The patients are unaware of what group they are assigned to, and the drug used. Drugs were prepared in the same and coded syringes by one of the anesthesiology specialists who are not in the study. In addition, the person assessing the outcome is different from the person who performs the injection of drugs and they are not aware of the type of drug injected to the patient. 3 Condition 1: Inguinal Hernia. Condition 2: Surgical Incision Pain. Intervention 1: First intervention group: in this group, 0.5 mg/kg of ketamine produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the icision site right before the closure of skin. Intervention 2: Second intervention group: in this group, 0.75 mg/kg of pethidine produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the incision site right before the closure of skin. Intervention 3: Third intervention group: in this group, 0.1 mg/kg of metoclopramide produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the incision site right before the closure of skin. Intervention 4: Control group: in this group, 10 ml of normal saline solution produced by Abidi company, will be injected subcutaneousely at the incision site right before the closure of skin. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to shortage of time that we have, we are not able to make any amendments or promises that we can share the output.
public Zahra Azamian
Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 405 0702 azamianza@yahoo.com Esfahan University of Medical Sciences scientific Darioush Moradi Farsani
Isfahan University of Medical Sciences, Hezarjrib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3625 5555 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The patients with ASA(American Society of Anesthesiologists) class I-II who are undergoing elective inguinal hernia repair under general anesthesia 18 years 65 years Both Uncontrolled systemic diseases Drug sensitivity to pethidine, metoclopramide and ketamine History of opium or alcohol addiction History of chronic pains in previous 6 months Any analgesic consumption in previous 24 hours History of Hypertension, Hyperthyroidism and psycologic disorders K40 G89.18 Inguinal hernia Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: in this group, 0.5 mg/kg of ketamine produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the icision site right before the closure of skin. Second intervention group: in this group, 0.75 mg/kg of pethidine produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the incision site right before the closure of skin. Third intervention group: in this group, 0.1 mg/kg of metoclopramide produced by Abidi company, which will be added to normal saline up to volume of 10 ml, will be injected subcutaneousely at the incision site right before the closure of skin. Control group: in this group, 10 ml of normal saline solution produced by Abidi company, will be injected subcutaneousely at the incision site right before the closure of skin. Local pain in the incision site of the surgery. Timepoint: Within the initial 24 hours after the surgical repairing of inguinal hernia. Method of measurement: Visual Analog Scale (VAS). Overall satisfaction of patients. Timepoint: 24 hours after the surgery. Method of measurement: Lickert scale from 1 to 5. Esfahan University of Medical Sciences Approved 2017-10-23 Ethics Committee of School of Medicine - Isfahan University of Medical Sciences Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)