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IRCT20210919052523N1 IRCT 2021-10-07 Esfahan University of Medical Sciences The effect of aminophylline, ketamine and paracetamol on pain severity after emptying of vitreous Preemptive effect of aminophylline, ketamine and paracetamol on pain intensity after deep vitrectomy surgery 2018-03-21 anticipated 240 Complete https://irct.ir/trial/58884 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Each of the patients is provided with a particular number by Random Allocation software allocated them to an intervention group. Each patient is provided with a particular number. Cases with numbers corresponded for 4*k are allocated to ketamine group, those with numbers corresponded for 4*k+1 are allocated to acetaminophen, those with numbers corresponded for 4*k+2 are allocated to the aminophylline group and those with numbers corresponded for 4*k+3 are allocated to placebo, Blinding description: In this study, patients are divided into groups 1 to 4 and no one knows the type of groups except the manager. Patients are received the same number of drugs based on group number, as well as anesthesiologist, data collector and statistical analyzer are blinded of grouping types. It is noteworthy that the drugs are prepared in the same containers and the same shape that the blinding is done completely. N/A Disorders of vitreous. Intervention 1: Intervention group: 20 minutes before surgery ending, about 0.15mg/kg of ketamine with 100 cc normal saline is injected intravenously. Intervention 2: Intervention group: 20 minutes before surgery ending, about 1g of acetaminophen with 100 cc normal saline is injected intravenously. Intervention 3: Intervention group: 20 minutes before surgery ending, about 3 mg/kg of aminophylline with 100 cc normal saline is injected intravenously. Intervention 4: Control group: 20 minutes before surgery ending, 100 cc normal saline is injected intravenously. Yes - There is a plan to make this available What will be shared: The data of the present study are provided by the relevant professor and in the case of publishing new and related studies are provided When: Following the publication of the article in an international journal, the data will be accessible To whom: Residents of anesthesiology who have a new proposal in this regard with the similar professor Conditions: Only for publication of a new article with the relevant professor Where to obtain: With the relevant anesthesiologist How to obtain: Following a call or an email to the relevant professor Comments:
public Iman Nikkhoo
Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 imannikkhoo1907@gmail.com Esfahan University of Medical Sciences scientific Iman Nikkhoo
Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 imannikkhoo1907@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Ages 40 to 80 years American society of anesthesiologists (ASA) physical status I or II Undergoing deep vitrectomy 40 years 80 years Both Cardiac arrest during surgery Any complications that required an alteration in anesthesia methods H43 Disorders of vitreous body Prevention Prevention Prevention N/A Intervention group: 20 minutes before surgery ending, about 0.15mg/kg of ketamine with 100 cc normal saline is injected intravenously. Intervention group: 20 minutes before surgery ending, about 1g of acetaminophen with 100 cc normal saline is injected intravenously. Intervention group: 20 minutes before surgery ending, about 3 mg/kg of aminophylline with 100 cc normal saline is injected intravenously Control group: 20 minutes before surgery ending, 100 cc normal saline is injected intravenously. Postoperative pain. Timepoint: Arrival to recovery and then at 15 and 30 minutes, 2, 4, 8, and 24 after entry to recovery unit. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2017-05-31 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)