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IRCT20190406043179N1 IRCT 2019-08-05 Sabzevar University of Medical Sciences Evaluation of Bupivacaine and Dexamethasone effect on Post Tonsillectomy Pain reduction Evaluation of peritonsillar infiltration of Bupivacaine and Dexamethasone effect on pediatric post tonsillectomy pain reduction 2019-07-21 anticipated 70 Complete https://irct.ir/trial/38820 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: randomization method: Simple randomization Randomization unit: individual Randomization tool: with using a random numbers table How to create a random sequence: using a random numbers table to read it from top to bottom and the even numbers belong to intervention group and the odd numbers belong to control group. Allocation concealment:using of Sequentially numbered, sealed, opaque envelopes, In this way that the numbers obtained by the random numbers table will be written on the cards respectively. each card will be put inside sealed opaque envelopes.Then envelopes will be numbered and placed in boxes respectively. In the next stage, the patients will enter the group by taking the envelopes respectively (Preparation of the envelopes will be done by the secretary and the physician will not be informed of them), Blinding description: Patients will not be informed about which group they are attending, until data collection will be finished. 3 Pediatric post tonsillectomy pain. Intervention 1: Intervention group: there are 35 of attended patients (according to the criteria of entering the study), who they will receive Bupivacaine 5 mg (ّFrance Astra Zeneca company) with Dexamethasone (Iran Hormon company) 0.3 mg per kilogram of patient weight as a direct peritonsillar injection, before Surgery. 10 minutes later surgery will be start. Intervention 2: Control group: there are 35 of attended patients (according to the criteria of entering the study), who they will not receive any Bupivacaine and Dexamethasone before surgery (According to the references, if patients did not get drug, they will not harm and this is acceptable). 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 information
public Kaveh Ghajari
Sabzevar University of Medical Sciences Central Organization, Asad Abadi street, Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 3765 7960 kaveh.gh90@gmail.com Sabzevar University of Medical Sciences scientific Mohamad Shuride Yazdi
Sabzevar University of Medical Sciences, Asad Abadi Ave
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4422 1425 drshurideh@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Tonsillectomy surgery indication Age between 4-15 years 4 years 15 years Both Asthma Chronic analgesic drugs use Usage of analgesic drugs at 24 hours before surgery Inability to connect with others Chronic disease Peritonsillar abscess history Present upper respiratory infection Treatment - Other Treatment - Other Intervention group: there are 35 of attended patients (according to the criteria of entering the study), who they will receive Bupivacaine 5 mg (ّFrance Astra Zeneca company) with Dexamethasone (Iran Hormon company) 0.3 mg per kilogram of patient weight as a direct peritonsillar injection, before Surgery. 10 minutes later surgery will be start. Control group: there are 35 of attended patients (according to the criteria of entering the study), who they will not receive any Bupivacaine and Dexamethasone before surgery (According to the references, if patients did not get drug, they will not harm and this is acceptable). Pediatric post tonsillectomy pain,. Timepoint: 6, 12, 24 hours after surgery. Method of measurement: Using of Visual Pain Analog Scale by executor of plan. Sabzevar University of Medical Sciences Approved 2019-03-16 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Shahr blvd, Sabzevar Sabzevar Razavi Khorasan Iran (Islamic Republic of)