]>
IRCT20231216060427N1 IRCT 2024-01-09 Mazandaran University of Medical Sciences The effect of topical ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in people under 18 years of age in Booalisina hospital from 2023 to 2024 The effect of topical ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in people under 18 years of age in Booalisina hospital from 2023 to 2024 2023-12-22 anticipated 60 Complete https://irct.ir/trial/74480 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To control the intervening variables and also to balance the groups in terms of number, a random block method was used based on the order of patients' entry, that is, from the first four patients, the data of 4 patients were allocated to two groups using random allocate software. Then this allocation of four continued until the samples were completed based on the sample size, Blinding description: After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Patients are included in the study in the order of table numbers. In the intervention group, at the beginning of the surgery, ketamine at a dose of 1mg/kg will be injected locally in the tonsillectomy area for all patients by the attending physician in the operating room. And the control group does not receive medicine. In the case of blinding, the patient and the nurse responsible for evaluating the pain score do not know whether the medicine has been injected into the patient or not. The student is an observer in the operating room. 2-3 Tonsillitis. Intervention 1: Intervention group: In the intervention group, at the beginning of the surgery, ketamine at a dose of 1mg/kg will be injected locally in the tonsillectomy area for all patients by the attending physician in the operating room. Intervention 2: Control group: The control group does not receive medication and the patient's pain is treated with intravenous acetaminophen at a dose of 12 mg/kg every 4 hours or 15 mg/kg every 6 hours with a maximum dose of 75 mg within 24 hours after the operation. 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 more information.
public Mahsa Heidari
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 drMahsaheidari@gmail.com Mazandaran University of Medical Sciences scientific Mahsa Heidari
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 drMahsaheidari@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) A person's willingness to participate in obtaining informed consent Chronic tonsillitis characterized by 7 or more episodes of sore throat per year for two consecutive years or 3 or more episodes of sore throat per year for three consecutive years. Occurrence of obstructive symptoms related to tonsil hypertrophy Patients of both sexes under 18 years of age 5 years 18 years Both The patient's unwillingness to continue to cooperate in the study History of taking painkillers Patients with a history of bleeding disorders Hemoglobin less than 10 g/dL History of rheumatological diseases Patients who have difficulty expressing pain J35 Chronic diseases of tonsils and adenoids Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, at the beginning of the surgery, ketamine at a dose of 1mg/kg will be injected locally in the tonsillectomy area for all patients by the attending physician in the operating room. Control group: The control group does not receive medication and the patient's pain is treated with intravenous acetaminophen at a dose of 12 mg/kg every 4 hours or 15 mg/kg every 6 hours with a maximum dose of 75 mg within 24 hours after the operation. The outcome of the patient's pain intensity after the operation based on the eye analog criterion. Timepoint: Pain intensity during recovery, 6 and 12 hours after surgery. Method of measurement: These results are measured by the evaluator, who is a trained nurse, who does not know about the allocation of the study subjects to each of the two allocation groups and the drugs used. Pain intensity is recorded during recovery 6 and 12 hours after the operation. The instrument for measuring this variable is based on the visual analog scale, and the face part of the visual analog scale will be used to measure the pain of patients aged 5 to 7 years, and the numerical part will be used to measure the pain of patients over 7 years old, and the help of the patient's parents will be taken to measure the pain.​. Mazandaran University of Medical Sciences Approved 2023-12-13 Ethic committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, at the begining of Valiasr Highway, Joibar three ways, imam Square,Sari, Mazndaran Province Sari Mazandaran Iran (Islamic Republic of)