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IRCT20190226042852N1 IRCT 2019-07-27 Ardabil University of Medical Sciences Effectivness of intravenous Acetaminophen and Ondansetron in prevention of shivering Effectivness of intravenous Acetaminophen and Ondansetron in prevention of postappendectomy shivering in general anesthesia method 2019-07-11 anticipated 150 Complete https://irct.ir/trial/39177 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Convenience sampling determines the inclusion of patients to this study.These patients will be randomly investigated in 3 groups of Acetaminophen,Ondansetron and Placebo.Closed packets will be employed as randomization tool in this study.To randomize 3packs of A,B and C will be prepared based on the sample size and randomly injected to the patients while considering the pack codes.Prepartion of these 3medicines will be done by an anesthetic technician not having any part in the research and then rendered for injection by a person who is unaware of the syringe content.In Acetaminophen group 15mg/kg and 8mg Ondansetron in Ondansetron group and 2cc Normal Salin in placebo group will be injected.To apply blinding,Solution for injection will contain an equal volume of2cc for all the three groups, Blinding description: Preparation of drugs will be done by Anesthetic technician who is no role in this study and injection will be done by person who nonaware of syringe matter.In Acetaminophen group 15mg/kg and 8mg Ondansetron in Ondansetron group and 2cc Normal Salin in plasebo group will be injected.Injectable solution volume in 3group will be equal(2cc).Another person who nonaware of type of injected drugs,evaluated patients post operative.Person who analize data not be aware of type of injected drugs. 3 Effectivness of acetaminophen and ondansetron in prevention ofshivering. Intervention 1: Intervention group: Intravenous Acetaminophen. Intervention 2: Intervention group: Intravenous ondansetron. Intervention 3: Control group: Normal salin. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Dr Hamed Zandian
univercity street,Ardebil university medicine sience
Ardebil Iran (Islamic Republic of) 8599156189 +45 33 52 22 47 h.zandian@arums.ac.ir Ardabil University of Medical Sciences scientific Ahmad Ghazi
University street
Ardebil Iran (Islamic Republic of) 8599156189 +98 224733524498 a.ghazi@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Satisfaction to enter the study Age between15_55 Class ASA I, II 15 years 55 years Both Exit requirement of study History of allergy to Acetaminophen or Ondansetron Rynaud syndrom Hypothyroid or Hyperthyroid Cardiovascular disease Body temprature>38or<36 T88.5 Other complications of anesthesia Treatment - Drugs Treatment - Drugs Placebo Intervention group: Intravenous Acetaminophen Intervention group: Intravenous ondansetron Control group: Normal salin Shivering. Timepoint: Postoperative. Method of measurement: grading of shivering. Ardabil University of Medical Sciences Approved 2018-02-18 Ethics committee of Ardabil University ofMedical Sciences university street,Ardabil Ardabil Ardabil Iran (Islamic Republic of)