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IRCT20160508027793N1 IRCT 2019-09-12 Hamedan University of Medical Sciences The IV Ondansetron on analgesic effects of IV Acetaminophen after pediatric tonsillectomy The effect of IV Ondansetron on analgesic effects of IV Acetaminophen after pediatric tonsillectomy: a double blinded randomized clinical trial 2019-08-15 anticipated 60 Complete https://irct.ir/trial/41333 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose we will use the Quadratic Block Randomization method. For this purpose, we provide four sheets of paper. On the two sheets the letter I means "Intervention" and on the other two sheets the letter C means "Comparison". Mix the sheets together and place in a drawer. On referral to each eligible patient, one leaflet will be randomly drawn and based on this leaflet, whether I or C, will be assigned to one of the intervention groups receiving ondansetron and acetaminophen or a comparison of acetaminophen recipients. It should be noted that the sheets that have been drawn out will not be returned to the drawer until they have been drawn out. After randomly pulling out all four sheets of all four sheets, all the sheets are returned to the drawer again and the procedure will continue again for the next four patients until the desired sample size is reached, Blinding description: In both intervention and control groups, intravenous acetaminophen will be prescribed 2 minutes before surgery, so the patient will not be informed of the prescription drug. Medications are provided by a technician so the anesthesiologist who will measure and record the outcome of the study will not be aware of the type of medication prescribed. In addition, the analyzer will not know the results of the coding of the intervention and comparison groups. Therefore, the study will be conducted in a triple blind manner. 3 Chronic tonsillitis and adenoiditis. Intervention 1: Intervention group: Intravenous ondansetron 0.1 mg / kg in 2 ml volume plus intravenous acetaminophen 15 mg / kg 15 minutes before surgery and acetaminophen suppository every 6 hours to 24 hours after surgery. Intervention 2: Control group: Intravenous normal saline 2 ml plus acetaminophen 2 mg / kg 15 min before end of surgery and acetaminophen suppository every 6 hours to 24 hours. Yes - There is a plan to make this available What will be shared: Mean pain score When: From 2018 to 12019 To whom: Researchers working in academic and scientific institutions Conditions: statistic analysis Where to obtain: Dr. Mahshid Nikooseresht Niko_mahshid@yahoo.com How to obtain: Send email to assistance professor Comments:
public Leyla Halimi
N37 , Ettehad Ally Zolfaghar street , Fatemieh Blv Besat Sq Hamedan , Iran
Hamedan Iran (Islamic Republic of) 6515934715 +98 81 3838 0032 lhhalimi20@yahoo.com Hamedan University of Medical Sciences scientific Mahshid Nikooseresht
in front of Mardom's Park, Pazhuhesh`s crossroad
Hamedan Iran (Islamic Republic of) 6517619664 +98 81 3838 0574 Niko_mahshid@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria :• Age 4-5 years: Candidate for elective adenotonsillectomy • Parental consent• • No history of psychiatric illness • Do not use the apparatus 2 hours before surgery • Insensitivity to ondansetron or acetaminophen • No history of venous hepatic disease 3 years 12 years Both • Failure to cooperate after initial interventions • Failure to show proper pain level • The patient has a decreased level of consciousness. J35.0 Chronic tonsillitis and adenoiditis Treatment - Drugs Treatment - Drugs Intervention group: Intravenous ondansetron 0.1 mg / kg in 2 ml volume plus intravenous acetaminophen 15 mg / kg 15 minutes before surgery and acetaminophen suppository every 6 hours to 24 hours after surgery Control group: Intravenous normal saline 2 ml plus acetaminophen 2 mg / kg 15 min before end of surgery and acetaminophen suppository every 6 hours to 24 hours Painless. Timepoint: 15 minutes before surgery and every 6 hours to 24 hours. Method of measurement: Children's hospital Eastern Ontario Pain Scale (ChEOPS). Nausea and vomiting. Timepoint: Four times at recovery, 6 hours, 12 hours and 24 hours after surgery. Method of measurement: ask. Hamedan University of Medical Sciences Approved 2019-08-14 Ethics committee of Hamedan University of Medical Sciences Opposite of Mardom`s Park , Pazhuhesh crossroad Hameedan Hamadan Iran (Islamic Republic of)