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IRCT20181226042142N1 IRCT 2019-03-16 Arak University of Medical Sciences The effect of topical use of bupivacaine and dexamethasone in tonsilar cavity in order to reduce pain after tonsillectomy The effect of topical use of bupivacaine and dexamethasone in tonsilar cavity in order to reduce pain after tonsillectomy 2019-05-23 anticipated 60 Complete https://irct.ir/trial/38116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized, double-blind clinical trial for patients undergoing tonsillectomy in Amirkabir Hospital. A total of 60 patients candidates for Tonsillectomy were randomly divided into two equal groups that using gases soaked dexamethasone and bupivacaine , or normal-saline in order to insert in the tonsilar cavity , Blinding description: In this study, only an otolaryngologist who is responsible for the study is aware of the type of study and the studied groups, while the patients , are not aware.also intern responsible for the plan that is responsible for filling the questionnaire ; it is not aware of the type of groups in terms of impacted drugs, and only knows the groups based on A and B, and fills the questionnaire on the basis of it. 3 The Effect of Topical Use of Bupivacaine and Dexamethasone in Tonsilar Cavity in order to Reduce Pain After Tonsillectomy. Intervention 1: Intervention group: After obtaining informed consent, 30 patients immediately after tonsillectomy place a gas soaked with bupivacaine and dexamethasone into the tonsillar cavity of each side for 10 minutes. In patients, they are given a 1 mg / kg of solution of bupivacaine 0.5 percent plus 1 mg of dexamethasone per kilogram (maximum 8 mg dexamethasone) and use normal saline to bring it to 10 cc and transfer to 2 gases and immediately after the tonsillectomy put it in the tonsillar cavity for ten minutes .Then, the pain score of patients in each of the two groups was measured in three replicates at 12 hours, 24 hours and one week after the intervention based on the checklist prepared. Intervention 2: Control group: After obtaining informed consent, 30 patients immediately after tonsillectomy, place a gas soaked with 10 cc normal saline in the tonsilar cavity of each side. Then, the pain levels of the patients in the two groups,measured in three replicates, 12 hours later ,24 hours later and one week after the intervention based on the checklist. 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 Mohammadreza Mohammadi
No. 29, Shahid Hamid Reza Shamsi Avenue,Imam Khomeini Street
Khomein Iran (Islamic Republic of) 3881963356 +98 86 4633 5314 www.mm80091@gmail.com Arak University of Medical Sciences scientific Mohammadreza Mohammadi
No. 29, Shahid Hamid Reza Shamsi Avenue,Imam Khomeini Street
Khomein Iran (Islamic Republic of) 3881963356 +98 86 4633 5314 www.mm80091@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients with frequent pharyngitis Patients with complaints of chronic bad breath and sore throat Patients with chronic tonsillitis 2 years no limit Both Coagulation disorders in patients Suspect malignancy Asymmetric of tonsiles J35 Chronic diseases of tonsils and adenoids Treatment - Drugs Placebo Intervention group: After obtaining informed consent, 30 patients immediately after tonsillectomy place a gas soaked with bupivacaine and dexamethasone into the tonsillar cavity of each side for 10 minutes. In patients, they are given a 1 mg / kg of solution of bupivacaine 0.5 percent plus 1 mg of dexamethasone per kilogram (maximum 8 mg dexamethasone) and use normal saline to bring it to 10 cc and transfer to 2 gases and immediately after the tonsillectomy put it in the tonsillar cavity for ten minutes .Then, the pain score of patients in each of the two groups was measured in three replicates at 12 hours, 24 hours and one week after the intervention based on the checklist prepared. Control group: After obtaining informed consent, 30 patients immediately after tonsillectomy, place a gas soaked with 10 cc normal saline in the tonsilar cavity of each side. Then, the pain levels of the patients in the two groups,measured in three replicates, 12 hours later ,24 hours later and one week after the intervention based on the checklist. Intensity of pain. Timepoint: 12 hours later and 24 hours later and one week after the intervention. Method of measurement: Based on checklist. Number of nausea and vomiting. Timepoint: 12 hours later and 24 hours later and one week after the intervention. Method of measurement: Based on checklist. Arak University of Medical Sciences Approved 2019-02-24 Ethics Committee of Arak University of Medical Sciences Sardasht - Basij Square- Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)