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

Finding an Effective, Lowly-Effective, and Cheap Drug to Reduce Pain In Candidates for Adenotonsillectomy

Triple blind randomized trials with 122 patients

Patients undergoing adenotonsillectomy surgery who have been admitted to the ENT clinic since the approval of this plan for one year, will be included in the study if they are eligible for entry and consent. Blind Mode: Due to the type of intervention and coding, patients, researchers, and analyst do not know the contents of the spray used.

Entry requirements: Children aged 4 to 12 years old from both sexes candidates for adenotonsillectomy Conditions of absence: Sensitivity to Turmeric, use of cautery in surgery, any systemic illness, lack of understanding of the child from the visual scale of pain, lack of consent of the child's parents

Intervention group: The surgical site is rinsed, then use a Turmeric 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 Buff, for 5 days Control group: The surgical sitewas rinsed, then using normal saline spray at 2 minutes before surgery and using the same spray immediately after surgery, then using spray once a day, 3 times each time. 2 puffs, for 5 days

Scale of sore throat in the Visual Analog Scale (VAS) Questionnaire in the first 5 days after adenotonsillectomy

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.

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.

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Nasser Bahari , num ; 00989398225654

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