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IRCT20190921044831N1 IRCT 2019-12-27 Kermen Medical University, Chancel of research "Effect of Tizanidine in reducing the pain of after septoplasty" Comparison of the effectiveness of oral Tizanidine in severity of pain after Septoplasty, in two groups of drug and placebo 2014-04-09 anticipated 71 Complete https://irct.ir/trial/42294 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization by Randomised number table, Blinding description: Surgeons and physicians who were assessing pain severity and anesthesia survivors and also patients were blinded. 3 Deviation of nasal septum. Intervention 1: Intervention group: Oral Tizanidine tablet 4 mg (Hakim Pharmacy Company) 2 hours before surgery. Intervention 2: Control group: Placebo, Oral Vitamin B1 100 mg tablet (Poursina Pharmacy Company) 2 hours before surgery. Yes - There is a plan to make this available What will be shared: The results of this clinical trial will be sent to the authored journals for publication and after publication, if any researchers who wish to cite this article requests, the coded information without any participants' personal information; will be sent. When: start of accessibility will be 3 months after publication To whom: محققینی که به طور معتبر قصد ارجاع به مقاله را دارند. Conditions: The results and preliminary data collected are confidential and coded by researchers who intend to refer to this article. Where to obtain: Formally request the corresponding author of the article. How to obtain: The applicant firstly proves his credibility as a researcher by introducing himself and his ORCID code, and then formally communicate with the corresponding author of the paper, explaining the title of his research and the purpose of obtaining this article's information and makes his request. After consulting with other authors, the author in charge of providing the researcher's request should be sure of the confidentiality of the data is maintained. Comments:
public علی اصغر عربی
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
kerman Iran (Islamic Republic of) ۷۶۱۸۷۵۱۱۵۱ +98 34 3132 5856 a_arabi@kmu.ac.ir Kerman University of Medical Sciences scientific َAliasghar Arabi Mianroodi
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
kerman Iran (Islamic Republic of) ۷۶۱۸۷۵۱۱۵۱ +98 34 3132 5856 a_arabi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with septoplasty class 1 or/and 2 ASA Not history of gastric ulcer Not history of using corticosteroids or other immune system suppressors 18 years 50 years Both Allergy to Tizanidine Age < 18 y or >50 y Re-Septoplasty Sinorhinoplasty Contraindication of Tizanidine therapy Cases that need to be treated differently by anesthesia or surgery Addiction Hepatic or renal disorder Cases of ASA 3 J34.2 Deflection or deviation of septum (nasal)(acquired) Treatment - Drugs Treatment - Drugs Intervention group: Oral Tizanidine tablet 4 mg (Hakim Pharmacy Company) 2 hours before surgery Control group: Placebo, Oral Vitamin B1 100 mg tablet (Poursina Pharmacy Company) 2 hours before surgery Pain of after septoplasty surgery. Timepoint: After 4, 8 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Kermen Medical University, Chancel of research Approved 2009-09-06 Kerman University of Medical Sciences Ethics committee Haft Bagh Alavi Highway Kerman Kerman Iran (Islamic Republic of)