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IRCT20141009019470N92 IRCT 2020-01-06 Shiraz University of Medical Sciences Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children 2020-02-04 anticipated 150 Complete https://irct.ir/trial/44675 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: These children will be randomly divided into 3 groups of 50 cases based on randomization chart which is derived from www.randomization.org, Blinding description: Assistant anesthesiologist who’s not involved in the data collection will prepare the syringe for each patient. Anesthesia nurse who is present in the operating room will not provide any information to the recovery staff after the surgery and deliver the patient to the recovery room, while, the patient, nurse, recovery officer, and data analyst will be briefed on the study. Have been. 2-3 Tonsillectomy. Intervention 1: Intervention group: The 1st group will receive ketamine 0.5 mg/kg and midazolam 0.01 mg/kg, 10 minute before the end of the surgery. Intervention 2: Intervention group: The second group will receive propofol 1 mg/kg and ketamine 0.5 mg/kg, 10 minute before the end of the surgery. Intervention 3: Intervention group: The third group received ketamine 0.5 mg/kg, 10 minute before the end of the surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our policies.
public Rezvan Haghighat
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 HAGHIGHAT@yahoo.com Shiraz University of Medical Sciences scientific Zeinabsadat Fatahi Saravi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 parniafattahi@rocketmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) ASA I-II Airway class I-II Normal BMI children aged 5-15 children candidate for elective adenotonsillectomy Isoflurane based anesthesia 5 years 15 years Both History of neuropsychiatric illness CHD URTI Seizure Drug reactions Any history of post operation complications Any complication of surgery or anesthesia that could cause agitation itself J35.01 Chronic tonsillitis Prevention Prevention Prevention Intervention group: The 1st group will receive ketamine 0.5 mg/kg and midazolam 0.01 mg/kg, 10 minute before the end of the surgery. Intervention group: The second group will receive propofol 1 mg/kg and ketamine 0.5 mg/kg, 10 minute before the end of the surgery. Intervention group: The third group received ketamine 0.5 mg/kg, 10 minute before the end of the surgery. Sedation. Timepoint: At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge. Method of measurement: Richmond Agitation & Sedation Scale (RASS). Pain. Timepoint: At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge. Method of measurement: Objective Pain Scale (OPS). Recover duration. Timepoint: At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge. Method of measurement: Modified Aldrete score. Shiraz University of Medical Sciences Approved 2018-02-22 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)