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IRCT20200825048515N34 IRCT 2021-05-30 Esfahan University of Medical Sciences Evaluation of preventive effect of injection paracetamol and lidocaine in reducing pain caused by intravenous injection of propofol in children Evaluation of preventive effect of injection paracetamol and lidocaine in reducing pain caused by intravenous injection of propofol in children aged 4 to 6 years 2021-06-05 anticipated 90 Complete https://irct.ir/trial/56246 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 90 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into three groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the three study groups, Blinding description: In this study, paracetamol, lidocaine, and placebo are prepared by the pharmacist and placed in coded packages, and delivered daily to an anesthesiologist, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 Inguinal surgery. Intervention 1: Intervention group 1: Patients in this group are injected with 1 mg / kg intravenous paracetamol one minute before propofol administration. Intervention 2: Intervention group 2: Patients in this group are injected with 1% lidocaine 1 mg / kg one minute before propofol administration. Intervention 3: Control group: Patients in this group are injected with 2 cc of normal saline one minute before propofol administration. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Sedigheh Shah-Hosseini
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 nasrin90ir@gmail.com Esfahan University of Medical Sciences scientific Sedigheh Shah-Hosseini
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 nasrin90ir@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children 4-6 years Has the American Association of Anesthesiologists (ASA) One and Two Candidate for inguinal surgery under general anesthesia with propofol 4 years 6 years Both Has underlying diseases (including liver, cardiovascular, neurological, metabolic disease, dermatitis) Having drug allergies K40 Inguinal hernia Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Patients in this group are injected with 1 mg / kg intravenous paracetamol one minute before propofol administration. Intervention group 2: Patients in this group are injected with 1% lidocaine 1 mg / kg one minute before propofol administration. Control group: Patients in this group are injected with 2 cc of normal saline one minute before propofol administration. Pain score. Timepoint: During injection of propofol. Method of measurement: Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC). Agitation score. Timepoint: During injection of propofol. Method of measurement: According to Richmond criteria. Mean Arterial Pressure. Timepoint: Before and one minute after the intervention. Method of measurement: Monitoring device. Hear rate. Timepoint: Before and one minute after the intervention. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2021-03-14 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)