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IRCT20230911059408N1 IRCT 2023-10-13 Islamic Azad University Comparación de los efectos de Apotel y Ketorolac antes de la cirugía sobre el dolor y la cantidad de narcóticos necesarios después de la cirugía abdominal Comparison of the effect of Apotel and Ketorolac before surgery on pain and the need for narcotics after abdominal surgery during the first 24 hours after surgery. 2023-10-22 anticipated 128 Complete https://irct.ir/trial/72938 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients were randomly divided into two groups A and B. The randomization method was performed as follows: First, a list of random numbers was generated using Excel software (using the Random Number Generation option). Then, these numbers were randomly assigned to patients. To maintain randomness, random numbers were generated and distributed by an individual independent of the study. In this study, block randomization method was used. In this method, patients were divided into small blocks and then each block was randomly assigned to one of two groups. The following method was used to randomize 128 patients into two groups of 64: First, the patients were divided into 16 blocks of 8 people (each block includes 4 people from group A and 4 people from group B, and each block will have 8 words from A and B). After that, in each block, people enter the groups randomly. Randomization will be done inside each block based on the table of random numbers, Blinding description: This research is a double-blind clinical trial (in order to make this study double-blind, the drugs used for the patients at the beginning of the study are A/B by the supervisor of the surgery department so that the clinical caregiver and the participants do not know the type of drug received. 3 Pain after abdominal surgery. Intervention 1: Intervention group: One hour before the operation, one group receives 1 gram of Apotel intravenously. Intervention 2: Control group: One hour before the operation, one group receives a 30 mg ketorolac ampoule as a honey injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahnaz Narimani Zamanabadi
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
Tehran Iran (Islamic Republic of) 1949635881 +98 21 2660 2642 mahnaznarimani@gmail.com Islamic Azad University scientific Mahnaz Narimani Zamanabadi
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran
Tehran Iran (Islamic Republic of) 1949635881 +98 21 2660 2642 mahnaznarimani@gmail.com Islamic Azad University Iran (Islamic Republic of) Elective surgery ASA1,2 (American Society of Anesthesiologists) Age 18-65 years Signing a personal consent form to enter the study No abuse of drugs, alcohol, cigarettes and psychotropic drugs 18 years 65 years Both Loss of consciousness Hemodynamic disorder Abnormal intraoperative bleeding The length of the operation more than 4 hours T81.9 Unspecified complication of procedure Prevention Prevention Intervention group: One hour before the operation, one group receives 1 gram of Apotel intravenously. Control group: One hour before the operation, one group receives a 30 mg ketorolac ampoule as a honey injection. Pain. Timepoint: 1, 6, 12, 24 hours after the operation. Method of measurement: Visual Analogue Scale. Islamic Azad University Approved 2023-09-04 Ethics Committee of ‏Tehran Islamic Azad University of Medical Sciences Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Ikh St., Aineh Blvd., Amir Pabarja St., Doktor Shariati St., Doktor Shariati St., Tehran Tehran Tehran Iran (Islamic Republic of)