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IRCT20141209020258N163 IRCT 2021-07-18 Arak University of Medical Sciences Comparison of Peritonsillar injection of mixture of Dexmedetomidine- Ropivacaine and tramadol - ‎Ropivacaine in postoperative pain control and sedation after tonsillectomy under general anesthesia Comparison of Peritonsillar injection of mixture of Dexmedetomidine- Ropivacaine and tramadol - ‎Ropivacaine in postoperative pain control and sedation after tonsillectomy under general anesthesia 2021-07-23 anticipated 99 Complete https://irct.ir/trial/57001 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random allocation with envelopes in 3 groups A and B and C. In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: In terms of patient blindness, the complementary intern does not know the groupings, and general anesthesia and drug injections are performed by an anesthesiologist. Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern. Also, the patients do not know about their group. 2-3 Tonsillectomy‎. Intervention 1: Intervention group1: 5 millilitre of a solution containing Ropivacaine 0.25% and 1 μg / kg of dexmedetomidine will be injected as a peritonsillar. (Dexmedetomidine made by Elixir Company - Iran). Intervention 2: Intervention group2: 5 millilitre of solution containing Ropivacaine 0.25% and 2 mg per kg of tramadol (manufactured by Caspian Tamin Iran - Rasht) will be injected as a peritonsilla. Intervention 3: Control group: 5 millilitre of 25% Ropivacaine solution with normal saline will be injected as a peritonsilla. 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 more information
public Dr Esmaeel Moshiri
Valiasr hospital, Valiasr square, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidate for tonsillectomy No metabolic glandular disease No coagulation disease No mental retardation Absence of peritonsillar abscess Absence of hypertension Absence of psychotic disorder Absence of chronic pain 3 years 12 years Both Dissatisfaction with the patient or parents' own surgery J03.9 Acute tonsillitis, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: 5 millilitre of a solution containing Ropivacaine 0.25% and 1 μg / kg of dexmedetomidine will be injected as a peritonsillar. (Dexmedetomidine made by Elixir Company - Iran) Intervention group2: 5 millilitre of solution containing Ropivacaine 0.25% and 2 mg per kg of tramadol (manufactured by Caspian Tamin Iran - Rasht) will be injected as a peritonsilla. Control group: 5 millilitre of 25% Ropivacaine solution with normal saline will be injected as a peritonsilla. Sedation. Timepoint: 5 minutes, 15 minutes, 30 minutes, 1, 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Wilson sedation scale. Pain. Timepoint: At 5 minutes, 15 minutes, 30 minutes, 1, 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Oucher‎ scale. Total dose of narcotics. Timepoint: 24 hours after surgery. Method of measurement: Hospital file. Arak University of Medical Sciences Approved 2021-05-30 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)