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IRCT20230208057353N1 IRCT 2023-03-06 Yasouj University of Medical Sciences comparison of ketamine and lidocaine in tonsilectomy comparison of the effect of peritonsillar injection of ketamine and lidocaine before tonsillectomy on pain after surgery 2023-03-21 anticipated 90 Complete https://irct.ir/trial/68480 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization: Randomization tool: website https://www.sealedenvelope.com/ How to make a random sequence: To perform this method at the beginning in the mentioned site, the number of intervention groups (three groups C, k and l ), the volume of each block (blocks of 6) and the number of sample size (90 people) were entered. Then the site presented a list with 15 blocks of 6. In this study, we use blocks of 6, and the website performs randomization and assigns numbers to the blocks. Allocation concealment method: sealed envelopes, Blinding description: The patients, the otolaryngologist who performs the surgery, the anesthesiologist who prescribes the anesthetic, and the anesthesiologist (MSc) who records the level of pain and restlessness, from the postoperative results of assigning the patients to two They do not know the group or drug used. The data analyst will also be unaware of which patient is ketamine, which is lidocaine, and which is part of the control group. 2-3 Tonsillectomy. Intervention 1: First intervention group: receiving ketamine. After intubation and anesthesia before surgical incision, peritonsillar injection of 2 ml of ketamine (ketamine will be diluted in 2 ml syringes) with a technique and as a fan from the upper poles. and below the tonsils by an injection surgeon and 5 minutes later the operation will begin. Blood pressure, heart rate (systolic and diastolic) and SpO2 will be recorded every ten minutes during surgery. The duration of anesthesia and operation is also recorded by the anesthesia assistant. Intervention 2: The second intervention group: receiving lidocaine. After intubation and anesthesia before surgical incision, peritonsillar injection of 2 ml of lidocaine (lidocaine will be diluted in 2 ml syringes) with a technique and as a fan from the upper poles. and below the tonsils by an injection surgeon and 5 minutes later the operation will begin. Blood pressure, heart rate (systolic and diastolic) and SpO2 will be recorded every ten minutes during surgery. The duration of anesthesia and operation is also recorded by the anesthesia assistant. Intervention 3: Control group: Control group: In this group, no action will be taken by the researcher and only their demographic information will be collected. 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 There is no further information
public Mahdi Asadi
Zirtel. University St. at the end of the street
Yasuj Iran (Islamic Republic of) 7591938839 +98 31 3858 5462 mahdiasadi1581376@gmail.com Yasouj University of Medical Sciences scientific Mahdi Asadi
Zirtel. University St. at the end of the street
Yasuj Iran (Islamic Republic of) 7591938839 +98 31 3858 5462 mahdiasadi1581376@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) The age of entering the study is 3 to 30 years Absence of metabolic and endocrine diseases No history of psychosis Speech ability in adults Absence of physical and mental disorders in children 3 years 30 years Both Allergy to injectable drugs Postoperative hemodynamic disorders Lack of satisfaction and cooperation after the operation Analgesics Treatment - Drugs Treatment - Drugs Treatment - Other First intervention group: receiving ketamine. After intubation and anesthesia before surgical incision, peritonsillar injection of 2 ml of ketamine (ketamine will be diluted in 2 ml syringes) with a technique and as a fan from the upper poles. and below the tonsils by an injection surgeon and 5 minutes later the operation will begin. Blood pressure, heart rate (systolic and diastolic) and SpO2 will be recorded every ten minutes during surgery. The duration of anesthesia and operation is also recorded by the anesthesia assistant. The second intervention group: receiving lidocaine. After intubation and anesthesia before surgical incision, peritonsillar injection of 2 ml of lidocaine (lidocaine will be diluted in 2 ml syringes) with a technique and as a fan from the upper poles. and below the tonsils by an injection surgeon and 5 minutes later the operation will begin. Blood pressure, heart rate (systolic and diastolic) and SpO2 will be recorded every ten minutes during surgery. The duration of anesthesia and operation is also recorded by the anesthesia assistant. Control group: Control group: In this group, no action will be taken by the researcher and only their demographic information will be collected. Pain. Timepoint: minute 30-60-90 after surgery. Method of measurement: Visual Analog Scale and Numeric Pain Rating Scale. Yasouj University of Medical Sciences Approved 2023-01-29 Ethics committee of Yasuj University of Medical Sciences Zirtol.Daneshgah Ave Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)