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IRCT2017051517756N14 IRCT 2017-07-05 Vice-chancellery for Research, Birjand University of Medical Sciences Comparing the effects of promethazine and gabapentin as premedication in reducing pain in tonsillectomy operation A clinical trial on the effects of promethazine and gabapentin as pre-medication in reducing postoperative pain in 7- to 9-year-old patients undergoing tonsillectomy 2017-07-23 anticipated 104 Complete https://irct.ir/trial/16254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Post-operative pain. Intervention 1: Intervention Group 1 (Gabapentin group): The gabapentin group receives 20 milligrams per kilogram along with 50 cc of water one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale. Intervention 2: Intervention Group 2 (The promethazine group): The group receives 0.5 cc per kilogram and up to a maximum dose of 25 milligram promethazine syrup orally one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale.
public Masoud Madihi
Ghaffari St., Birjand University of Medical Sciences,
Birjand, Iran (Islamic Republic of) +98 56 3239 5680 masoud.madihi@gmail.com Birjand University of Medical Sciences scientific Dr Mahmoud Ganjifard
Vali-e Asr Hospital, Ghaffari St.,
Birjand, Iran (Islamic Republic of) +98 56 3239 5680 ganji50@hotmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: non-addiction to and non-use of psychotropic and psychoactive drugs; no history of anxiety, neuropsychiatric, and hyperactivity disorders or chronic pain; age between 7 and 15 years; patient referred by the ENT specialist, co-researcher in this project; non-use of drugs effective on heart rate and pressure; informed consent. Exclusion criteria: Surgery length over 30 minutes; complications during or after surgery, e.g., bleeding and hypoxia 7 years 15 years Both R07.0 Pain in throat Treatment - Drugs Treatment - Drugs Intervention Group 1 (Gabapentin group): The gabapentin group receives 20 milligrams per kilogram along with 50 cc of water one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale. Intervention Group 2 (The promethazine group): The group receives 0.5 cc per kilogram and up to a maximum dose of 25 milligram promethazine syrup orally one hour before anesthesia. Postoperative pain at 3, 6, 12 and 24 hours after the operation will be measured using the Medical Objective Pain Scale. Pain severity. Timepoint: 3, 6, 12 and 24 hours after operation. Method of measurement: Medical Objective Pain Scale. Vice-chancellery for Research, Birjand University of Medical Sciences Approved 2017-05-01 Ethics Committee of Birjand University of Medical Sciences Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari St., Birjand, Iran (Islamic Republic of)