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IRCT20210403050824N1 IRCT 2021-07-11 Esfahan University of Medical Sciences paracetamol and lidocaine in pain of intravenous propofol Comparative study of prophylactic effect of injectable paracetamol and lidocaine on pain caused by intravenous injection of propofol in children 6 to 10 years 2021-07-21 anticipated 90 Complete https://irct.ir/trial/55358 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random sequence (blocking) is generated by the help of Excel software and blocks of six are used to equalize the three groups so that the intervention groups 1 and 2 or the control of each person included in the study, can be determined randomly and equally. The blocks of six are separated from the samples and placed in the block randomly by the Excel software of group A or B or C. At the end, it is determined which letter represents the intervention group 1 and 2 and which is for the control group, Blinding description: The drugs are prepared by someone outside the research team in the operating room. He equalize their volumes in ready-made syringes with a coating so that its contents are not known. Group codes are then written on the syringes. The anesthetist who inject the drug and the anesthesiologist who collect the data do not know the group's codes. Patients are also unaware of group assignments. The person who is doing the statistical analysis also does not know how the codes have been assigned to the study groups. After completing the analysis, the codes will be opened. 3 Pain induced by intravenous propofol injection.. Intervention 1: The first intervention group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 1 milligram per kilogram of Paracetamol will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire. Intervention 2: The second intervention group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 1 milligram per kilogram of lidocaine 1% will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire. Intervention 3: The control group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 2 cc of normal saline will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire.ed in a questionnaire. 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 The data are not completed yet.
public Ahmad Karimi hasan abadi
No 59,Yasaman Ave., Delgosha St., Najaf Abad
Najafabad Iran (Islamic Republic of) 8517775899 +98 31 4274 3155 ahmadkarimi1886@gmail.com Esfahan University of Medical Sciences scientific Sedigheh Shahhoseini
No 6, Pasandidideh Al, East Allameh Amini St
Isfahan Iran (Islamic Republic of) 8156674943 +98 31 3261 2181 nasrin20ir@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children 6 to 10 years general anesthesia with propofol ASA1,ASA2 6 years 10 years Both Known liver disease Known heart disease Known neurological disease History of metabolic disease Drug reactions and allergies T88.5 Other complications of anesthesia Prevention Prevention Placebo The first intervention group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 1 milligram per kilogram of Paracetamol will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire. The second intervention group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 1 milligram per kilogram of lidocaine 1% will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire. The control group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 2 cc of normal saline will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire.ed in a questionnaire. Patient pain score at baseline and one minute after propofol injection. Timepoint: At baseline when injecting propofol and one minute after injecting propofol. Method of measurement: Propofol injection pain score based on the patient's motor and verbal response. Heart rate at baseline and one minute after propofol administration. Timepoint: At baseline and one minute after propofol injection. Method of measurement: Saadat Standard monitoring. Mean arterial pressure at baseline and one minute after propofol injection. Timepoint: At baseline and one minute after propofol injection. Method of measurement: Saadat Standard monitoring. Patient agitation during propofol injection. Timepoint: At baseline and one minute after propofol injection. Method of measurement: Richmond Agitation scale. Isfahan University of Medical Sciences Approved 2020-10-17 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Science., Hezar Jarib Ave., Azadi Sq., Isfahan Isfahan Isfehan Iran (Islamic Republic of)