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IRCT20130713013976N6 IRCT 2018-12-05 Hamedan University of Medical Sciences Effect of Curcumin in Adenotonsillectomy pain reduction Study of the efficacy of Turmeric oil oral spray (Curcumin) on reduction of post Adenotonsillectomy pain in 4-12 years old children: three blind randomized clinical trial 2018-10-23 anticipated 122 Complete https://irct.ir/trial/35423 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the Block Randomization block method. In this method, we prepare four paper sheets. On the two letters "C" means "Curcuma Longa" (intervention group) and we write two letters of the letter "N" meaning "Normal Saline" (control group). We mix the sheets together. Then, by random selection of the sheets, the Turmeric and Normal Saline spray from one to one hundred and twenty will be numbered respectively. The drug code will be covered by researchers until the end of the study. By referring to each patient, we choose one of the vials randomly and deliver it to the patient. The scientist who will deliver the medication to the patient and the patient interviewer will not be aware of the type of medication used. Then, the data collected by the C, N codes (these codes refer to Turmeric spray and Normal Saline, and the analyzer does not know how to assign the codes to the drugs), will enter the statistical software version 16 and will be analyzed. After the data is analyzed and the results are finalized, the drug code is decoded and the effect of each drug will be identified and recorded, Blinding description: In this study, the shape of both sprays (Curcumin and placebo) was identical and randomly Quadrupled randomized blocks were randomly assigned. Spray distributors (researchers) and patients and the person who performs statistical analysis do not know the nature of the substance in the spray. After analyzing the data and identifying the results, the drug code is decoded and the effect of each drug will be identified and recorded. Therefore, this study is done in a three blind randomized clinical trial. 3 Adenotonsillar hypertrophy. Intervention 1: Intervention group: The surgical site is rinsed, then use aTurmeric spray spray at 2 puffs one minute before surgery and use the same amount of spray immediately after surgery, then use spray once a day 3 times and 2 times. Intervention 2: Control group: The surgical site is rinsed, then using normal saline spray at 2 minutes before surgery and using the same spray as immediately after surgery, then using spray 3 times a day, 2 puffs per day, For 5 days. 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 No more information
public Nasser Bahari
University of Medical science, Ayatollah Kashani Blvd, Hamadan, Iran.
Hamedan Iran (Islamic Republic of) 1234567890 +98 939 822 5654 naser.bahaari.medicalstudent@gmail.com Hamedan University of Medical Sciences scientific Javaneh Jahanshahi
BESAT hospital, Hamadan
Hamedan Iran (Islamic Republic of) 1234567890 +98 81 3264 0020 J.JAHANSHAHI@UMSHA.AC.IR Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients undergoing Adenotonsillectomy Age 4 to 12 years of both sexes 4 years 12 years Both Sensitivity to Turmeric Using cautery during surgery In the absence of understanding the pain assessment images by the child and the inability to intervene and lack of parental support Any known systemic disease, such as congenital anomalies, bleeding disorders, type 1 diabetes, kidney disease, colds, and fever Treatment - Drugs Treatment - Drugs Intervention group: The surgical site is rinsed, then use aTurmeric spray spray at 2 puffs one minute before surgery and use the same amount of spray immediately after surgery, then use spray once a day 3 times and 2 times Control group: The surgical site is rinsed, then using normal saline spray at 2 minutes before surgery and using the same spray as immediately after surgery, then using spray 3 times a day, 2 puffs per day, For 5 days Scale of sore throat in the Visual Analog Scale (VAS). Timepoint: Measurement of sore throat in the first 5 days after Adenotonsillectomy. Method of measurement: Visual Analogue Scale. The frequency of use of prescribed acetaminophen intake. Timepoint: In the first 5 days after Adenotonsillectomy. Method of measurement: Questionnaire. Having or not having ear pain (autoelastic). Timepoint: In the first 5 days after Adenotonsillectomy. Method of measurement: Questionnaire. Tolerate normal diet. Timepoint: In the first 5 days after Adenotonsillectomy. Method of measurement: Questionnaire. Having or not having nausea. Timepoint: In the first 5 days after Adenotonsillectomy. Method of measurement: Questionnaire. Hamedan University of Medical Sciences Approved 2018-09-22 Ethics committee of Hamadan University of Medical Science Ethics Committee of Hamadan University of Medical Science, Khaje Rashid Blv., Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)