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IRCT20191022045200N1 IRCT 2019-10-28 Arak University of Medical Sciences The effect of dexamethasone and ketamine on postoperative pain Comparison of addition of ketamine and dexamethasone to ropivacaine in peritonsillar infiltration to reduce postoperative pain 2019-04-21 anticipated 92 Complete https://irct.ir/trial/43227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 5 patients, aged 4-5 years, referred to Amir Kabir Hospital in Arak, were diagnosed with tonsillectomy and met inclusion criteria after obtaining informed consent. Patients were then randomly divided into two groups of dexamethasone plus bupivacaine and ketamine plus bupivacaine, Blinding description: Blindness Due to the double blindness of the study, only the relevant expert in this study is aware of the type of study and study groups, while patients are not aware of the type of drug being used. Also, the intern who is responsible for the design of the checklist is not aware of the groups based on the injectable drug and only identifies the groups based on A and B and fills the checklists accordingly. 2-3 Tonsillectomy. Intervention 1: First Intervention group: 2 cc of ropivacaine 0.5% plus dexamethasone 0.5 mg / kg (maximum 1 mg) with distilled water delivered to CC 10 and injected into the peritonsillar fossa by the surgeon so that the injection was only in the sub mucus area. 5cm injection is given on each side. Intervention 2: Second Intervention group: CC 2 of 0.5% ropivacaine solution plus 0.5 mg / kg ketamine with distilled water is delivered to CC 10 and injected into the peritonsillar fossa by the surgeon so that the injection is only in the sub mucus area. 5cm injection is given on each side. 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 informations
public Fatemeh Hoseini
No. 68, Fourteen Alley, Somayeh Blv, Moallem Sq.
Qom Iran (Islamic Republic of) 3715694439 +98 25 3774 4933 S_zeiho@yahoo.com Arak University of Medical Sciences scientific Fatemeh Hoseini
No. 68, Fourteen Alley, Somayeh Blv, Moallem Sq.
Qom Iran (Islamic Republic of) 3715694439 +98 25 3774 4933 S_zeiho@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Children 1 to 4 years old candidate for elective tonsillectomy Absence of underlying cardiovascular, respiratory, kidney, liver and brain diseases No history of motion sickness 3 years 15 years Both Surgery lasts more than 4 hours Bleeding action greater than 10 cc / kg J35.03 Chronic tonsillitis and adenoiditis Treatment - Drugs Treatment - Drugs First Intervention group: 2 cc of ropivacaine 0.5% plus dexamethasone 0.5 mg / kg (maximum 1 mg) with distilled water delivered to CC 10 and injected into the peritonsillar fossa by the surgeon so that the injection was only in the sub mucus area. 5cm injection is given on each side. Second Intervention group: CC 2 of 0.5% ropivacaine solution plus 0.5 mg / kg ketamine with distilled water is delivered to CC 10 and injected into the peritonsillar fossa by the surgeon so that the injection is only in the sub mucus area. 5cm injection is given on each side. Pain score on the Visual Analogue Scale. Timepoint: Minutes 15, 30 and 2, 4, 8, 16, 24 hours after surgery. Method of measurement: Visual Analogue Scale ruler. Patient Agitation rate. Timepoint: Minutes 15, 30 and 2, 4, 8, 16, 24 hours after surgery. Method of measurement: Riker Sedation-Agitation scale. Arak University of Medical Sciences Approved 2018-06-10 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Sardasht Town Arak Markazi Iran (Islamic Republic of)