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IRCT20230716058807N1 IRCT 2023-08-01 Qazvin University of Medical Sciences Comparison of postoperative analgesic effect of intravenous acetaminophen versus intravenous caffeine in distal radius surgery Comparison of postoperative analgesic effect of intravenous acetaminophen versus intravenous caffeine in distal radius surgery 2023-08-06 anticipated 90 Complete https://irct.ir/trial/71396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a double-blind randomized clinical trial that is conducted in patients referred to medical training centers of Qazvin University of Medical Sciences who are candidates for distal radius surgery according to the instructions of the orthopedic surgeon. Patients who met the necessary conditions, after full training by an anesthesiologist and filling in the patient's informed personal consent form, entered the study, after randomly selecting the patients, they were divided into three groups, and then the intervention was carried out.In this way: one of the three test groups will be A (acetaminophen drug), test group C (caffeine drug) and control group O (placebo). Sampling is done using the available method. Allocation of samples to intervention groups will be done using color cards method, Blinding description: This is a double-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group. 3 distal radius surgery. Intervention 1: Intervention group: 10 mg/kg of injectable acetaminophen is diluted in 100 cc of normal saline and infused to the patient over 30 minutes. Intervention 2: Intervention group: 1 mg/kg of injectable caffeine diluted in 100 cc of normal saline is infused to the patient over 30 minutes. Intervention 3: Control group: 10 cc of normal saline is diluted by microset in 100 cc of normal saline and is infused to the patient over 30 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Satisfaction of participants
public Hamed Talayeh
Bahonar street
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 hamed_talayeh@yahoo.com Qazvin University of Medical Sciences scientific Hamed Talayeh
University campus building, Bahonar Blvd
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 hamed_talayeh@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study Age 20 to 60 years Distal radius fracture General anesthesia 20 years 60 years Both Unwillingness to cooperate in the study Cardiac patients with a history of HTN (heart rate over 100 during surgery/blood pressure over 140 mm Hg during surgery) Occurrence of any problems and complications during the study Pregnancy, breastfeeding and abortion less than 3 months Allergy to acetaminophen/caffeine/morphine Long-term use of corticosteroids, antihistamines, narcotics and pain relievers Vision and hearing problems and other disabilities Chronic mental and physical illness (schizophrenia, diabetes, etc) Liver patients (hepatitis, cirrhosis, etc.) History of smoking, alcohol and drugs The duration of surgery should be less than 45 minutes S52.5 Fracture of lower end of radius Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: 10 mg/kg of injectable acetaminophen is diluted in 100 cc of normal saline and infused to the patient over 30 minutes. Intervention group: 1 mg/kg of injectable caffeine diluted in 100 cc of normal saline is infused to the patient over 30 minutes. Control group: 10 cc of normal saline is diluted by microset in 100 cc of normal saline and is infused to the patient over 30 minutes. The amount and intensity of pain. Timepoint: 1, 3, 6 and 12 hours after the operation. Method of measurement: Using a ruler-like grading system (Visual Analog Scale) from 0 (no pain) to 10 (the most severe pain imaginable). Qazvin University of Medical Sciences Approved 2021-11-17 Ethics committee of qazvin University of Medical Sciences Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin Qazvin Qazvin Iran (Islamic Republic of)