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IRCT201402179014N25 IRCT 2014-05-26 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences The effect of intravenous ketamine plus paracetamol versus intravenous paracetamol alone on postoperative pain, nausea and vomiting after pediatric adenotonsilectomy The effect of intravenous ketamine plus paracetamol versus intravenous paracetamol alone on postoperative pain, nausea and vomiting after pediatric adenotonsilectomy: a triple blinded randomized clinical trial 2014-06-22 anticipated 98 Complete https://irct.ir/trial/9464 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Using balance blocks randomization with block of four. Blinding: The drugs are prescribed during surgery hence the patients will not aware of the type of medications. Furthermore, the anesthesiologist who will assess the effect of the intervention will be aware of the coding of the intervention and control groups. In addition, the analyzer will not aware of the coding either. Therefore, the trial will be run triple blinded. 2 Condition 1: Pain in throat. Condition 2: Nausea and vomiting. Intervention 1: Intravenous ketamine 0.25 mg/kg (2 ml) single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery. Intervention 2: Intravenous normal saline 2 ml single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery.
public Dr Lida Noori
Beasat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 918 341 6392 Dr.lidanori@yahoo.com Beasat Hospital scientific Dr Hossein Kimiaei
Beasat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 1341 6392 kimiaei@umsha.ac.ir Beasat Hospital Iran (Islamic Republic of) Inclusion criteria: (a) 3 to 12 years old; (b) candidate for elective adenotonsilectomy; having one or two criteria based on Physical Status Classification American Society of Anesthesiologists (ASA) Exclusion criteria: (a) history of psychiatric disease; (b) using analgesic within 24 hours before surgery; (c) sensitivity to ketamine or acetaminophen; (d) using cautery for hemostasis. 3 years 12 years Male R07.0 R11 Pain in throat Nausea and vomiting Treatment - Drugs Placebo Intravenous ketamine 0.25 mg/kg (2 ml) single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery. Intravenous normal saline 2 ml single dose plus intravenous acetaminophen 15 mg/kg single dose, 15 min before the end of surgery and every 6 hours until 24 hours after surgery. Pain severity. Timepoint: at 0.5, 6, 12, and 12 hours after surgery. Method of measurement: based on the CHEOPS Pain Score. Number of nausea and vomiting. Timepoint: at 0.5, 6, 12, and 12 hours after surgery. Method of measurement: based on clinical observation. The duration of time to use the first narcotic. Timepoint: per min after surgery. Method of measurement: based on medical record. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2014-05-17 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)