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IRCT20100518003954N9 IRCT 2020-02-14 Hamedan University of Medical Sciences The effect of ketamine and dexmedetomidine on preoperative sedation and intraoperative bleeding and analgesia during recovery Comparing the effect of intranasal ketamin and intranasal dexmedetomedin versus placebo on sedation,bleeding,pain & agitation in children undergoing adenotonsilectomy 2018-08-23 anticipated 3 Complete https://irct.ir/trial/42706 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: For this purpose we will use the hexadecimal random blocks method. For this purpose, we produce six sheets of paper. On the two sheets the letter K means "Ketamin" and on the other two sheets the letter D "dexmedetomedin" and on the two sheets the letter P means Placebo. Mix the sheets together and place in a drawer. On referral to each eligible patient, one leaf was randomly drawn and assigned to one of three study groups according to this leaflet, whether K, D or P. It should be noted that the drawn sheets will not be returned to the drawer until all six sheets have been drawn. After randomly pulling out all six sheets, all sheets will be returned to the drawer and the same operation will continue for the next six patients until the desired sample size (93 patients) is reached, Blinding description: In this study, the researcher first presents the necessary explanations to the child's father {patient's father}. In the drawer she receives from the nurse, the patient is left unaware of the chosen group. Questionnaires and surveys are carried out by the researcher to the end. The analyzer analyzes the data based solely on the three types of groups a, b, and c, and after receiving the information from the analyzer, the nurse determines the relationship between the groups at the end. 3 Evaluation of the effect of ketamine or dexmedetomidine on placebo for preoperative relaxation& Intraoperative hemorrhage and postoperative analgesia in patients undergoing adenotonsillectomy. Intervention group: This study is a randomized clinical trial of children in need of elective adenotonsillectomy with ASA status I and II in Hamadan Baysat Hospital in 1397. After sufficient explanation is given to parents if they consent to participate in the informed consent study. Patients were randomly divided into three groups: dexmedetomidine (D), ketamine (k) and placebo (normal saline (NS)). Patients were given 2μg / kg of dexmodetimidine or 5mg / kg of ketamine 30 minutes before induction of anesthesia and in the control group received 5 drops of 9% normal saline with 2mg syringe when the child was present with their parents.Medications are given in both nostrils in recumbent position. Blood pressure, pulse rate, and Spo2 were measured every 15 minutes until the patient was discharged from the recovery room. Patients were treated with 1mg / kg fentanyl intravenously and anesthetized with isoflurane 20 minutes prior to anesthesia. Completion of the procedure for all patients for analgesia is 15 mg / kg of acetaminophen infused with 20 cc normal saline. Intervention group 1: Intranasal ketamine 5 mg / kg once 30 min before anesthesia • Intervention group 2: Intranasal dexmedothymidine 2 micrograms per kg 30 minutes before anesthesia • Comparison group: Normal saline intravenously Nose 4 drops once 30 minutes before anesthesia begins. Yes - There is a plan to make this available What will be shared: Individual data of study participants, after unidentifiable individuals, can be shared in most tables and graphs. When: Start data access period 6 month after printing results To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: It is possible to use the data after obtaining the written consent of the researchers Where to obtain: Dr. Mohammad Hossein Bakhshai : bakhshaei@umsha.ac.ir Dr. Mohsen Zarei : drm.zarei@yahoo.com How to obtain: If you send an email, the data request will be answered within a week. Comments:
public Mohsen Zarei
Bassat Hospital, Beheshti Blvd.
Hamedan Iran (Islamic Republic of) 6515713834 +98 81 3264 0020 drm.zarei@yahoo.com Hamedan University of Medical Sciences scientific Mohammad Hossein Bakhshaei
Bassat Hospital, Shahid Beheshti Boulevard
hamedan Iran (Islamic Republic of) 6515713834 +98 81 3264 0021 bakhshaei@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Children undergoing adenotonsillectomy surgery who do not have concomitant disease. 4 years 12 years Both Drug sensitivity to ketamine or dexmedothymidine Mental retardation ADHD Psychiatric drug use History of heart, kidney, liver disease Any pathological problems in the nose Patients who return to the operating room due to postoperative bleeding Treatment - Drugs Intervention group: This study is a randomized clinical trial of children in need of elective adenotonsillectomy with ASA status I and II in Hamadan Baysat Hospital in 1397. After sufficient explanation is given to parents if they consent to participate in the informed consent study. Patients were randomly divided into three groups: dexmedetomidine (D), ketamine (k) and placebo (normal saline (NS)). Patients were given 2μg / kg of dexmodetimidine or 5mg / kg of ketamine 30 minutes before induction of anesthesia and in the control group received 5 drops of 9% normal saline with 2mg syringe when the child was present with their parents.Medications are given in both nostrils in recumbent position. Blood pressure, pulse rate, and Spo2 were measured every 15 minutes until the patient was discharged from the recovery room. Patients were treated with 1mg / kg fentanyl intravenously and anesthetized with isoflurane 20 minutes prior to anesthesia. Completion of the procedure for all patients for analgesia is 15 mg / kg of acetaminophen infused with 20 cc normal saline. Intervention group 1: Intranasal ketamine 5 mg / kg once 30 min before anesthesia • Intervention group 2: Intranasal dexmedothymidine 2 micrograms per kg 30 minutes before anesthesia • Comparison group: Normal saline intravenously Nose 4 drops once 30 minutes before anesthesia begins Relaxation before intranasal injection of ketamine or dexmedetomidine in adenotonsillectomy. Timepoint: Evaluation of sedation before adenotonsillectomy in children receiving intranasal ketamine or dexmedetomidine versus placebo 15 and 30 minutes after drug administration. Method of measurement: Questionnaire according to clinical criteria. Evaluation of the effect of medication on intraoperative bleeding. Timepoint: At the end of surgery. Method of measurement: Calculation of bleeding inside the suction bottle and bleeding medical gases. Evaluation of the effect of medication on postoperative pain and restlessness. Timepoint: Evaluation of patient pain and restlessness at 15, 30, 45 and 60 minutes after surgery in recovery. Method of measurement: Using the standard questionnaire: Children's Hospital of Eastern Ontario pain score and Pediatric Anesthesia Emergency Delirium (PAED) scal. Hamedan University of Medical Sciences Approved 2018-07-09 Ethics committee of Hamedan university of Medical sciences Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)