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IRCT20220508054785N1 IRCT 2022-08-31 Sabzevar University of Medical Sciences Injection of dexmedetomidine in reduction of pain in pediatrics tonsillectomy Submucosal injection of dexmedetomidine in reduction of postoperative pain in pediatric tonsillectomy 2022-10-23 anticipated 35 Complete https://irct.ir/trial/65039 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: this project which is actually a clinical trial aims to investigate the injection of dexmedetomidine in reduction of pain in pediatrics tonsillectomy patients who are divided into intervention and control group based on permutation block, Blinding description: The drug dexmedetomidine and normal saline with the same volume and in the same shape syringes are prepared by an anesthetist who knows the content of the research and is fully justified and is marked with code A or B. In this way, the researcher evaluates the patients only based on the code without knowing whether the patient is in the dexmedetomidine or normal saline group. 2 Tonsillectomy. Intervention 1: Intervention group: anaesthesia is induced by fentanyl 4 μg/kg &and propefol 2 μg/kg & atracurium 0.4 μg/kg after 3 minutes tracheal intubation and ventilation are performed and anaesthesia is maintained with nitrousoxide50% and oxygen 50% and isoflorane1.2 . the children were locally infiltrated with 1 μg/kg dexmedetomidine into the pretonsillar space by sergeon { between upper and lower parts of tonsils}. Intervention 2: Control group: anaesthesia is induced by fentanyl 4 μg/kg &and propefol 2 μg/kg & atracurium 0.4 μg/kg after 3 minutes tracheal intubation and ventilation are performed and anaesthesia is maintained with nitrousoxide50% and oxygen 50% and isoflorane1.2 .after anaesthesia normal saline with the same volume and in the same shape syringes with dexmetedomine are prepared and were locally infiltrated into the peritonsillar space by surgeon. 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 There is no further information.
public Shakiba mozari
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 sh.mozari@gmail.com Sabzevar University of Medical Sciences scientific Shakiba mozari
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 sh.mozari@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Candidate for tonsillectomy surgery 4 to 15 years ASA class I&II No peritonsillar abscess No chronic pain Not taking painkillers 24 hours before surgery 4 years 15 years Both Parents' lack of consent to continue attending the study History of allergy to any medicine Coagulation disorder Liver disorders Uncontrolled diabetes (ASA 3 and above) Active upper respiratory tract infection Occurrence of complications during surgery Increasing the recovery period to more than 60 minutes Increasing the duration of surgery Treatment - Drugs Treatment - Drugs Intervention group: anaesthesia is induced by fentanyl 4 μg/kg &and propefol 2 μg/kg & atracurium 0.4 μg/kg after 3 minutes tracheal intubation and ventilation are performed and anaesthesia is maintained with nitrousoxide50% and oxygen 50% and isoflorane1.2 . the children were locally infiltrated with 1 μg/kg dexmedetomidine into the pretonsillar space by sergeon { between upper and lower parts of tonsils} Control group: anaesthesia is induced by fentanyl 4 μg/kg &and propefol 2 μg/kg & atracurium 0.4 μg/kg after 3 minutes tracheal intubation and ventilation are performed and anaesthesia is maintained with nitrousoxide50% and oxygen 50% and isoflorane1.2 .after anaesthesia normal saline with the same volume and in the same shape syringes with dexmetedomine are prepared and were locally infiltrated into the peritonsillar space by surgeon. Severity of pain after tonsil surgery. Timepoint: 4, 8, 12 and 24 after the intervention. Method of measurement: Faces Pain Scale-Revised (FPS-R). Sabzevar University of Medical Sciences Approved 2022-02-13 Ethics Committee of Sabzevar University of Medical Sciences Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)