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IRCT20120118008768N9 IRCT 2019-03-17 Hamedan University of Medical Sciences Evaluation of the effect of superhydration on postoperative nausea and vomiting after tonsillectomy Comparison of the effects of restrictive and liberal fluid therapy on Postoperative nausea and vomiting in pediatric tonsillectomy surgery 2018-10-09 anticipated 110 Complete https://irct.ir/trial/35250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization with sealed envelope For this purpose 4 papers were prepared. The letter "I" for Internention was written on 2 papers and the letter "C" for Comparison was written on two another papers. All 4 sheets were placed in a drawer and for including each patient one sheet was pulled out. According to the letter on the sheet "I" or "C"; the patient was assigned to intervention (leg elevation) or control (supine position) group. All of the four sheets were re-turned to the drawer and this cycle will be continued to meet the calculated sample size, Blinding description: Patients, the person who collects data and the person who analyzes the data are blinded. N/A Nausea and vomiting. Intervention 1: Intervention group: (superhydration) Ringer lactate infusion 30cc/kg at the time of operation. Intervention 2: Control group: Infusion of 10cc/kg Lactated Ringer during surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahshid Nikooseresht
Anesthesiolgy Department, Besat Hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
Hamadan Iran (Islamic Republic of) 6514845471 +98 81 3264 0050 nikoo_mahshid@yahoo.com Hamedan University of Medical Sciences scientific Mahshid Nikooseresht
Anesthesiolgy Department, Besat Hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
Hamadan Iran (Islamic Republic of) 6514845471 +98 81 3264 0050 nikoo_mahshid@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Healthy children aged between 2-12 yr Candidate for tonsillectomy 2 years 12 years Both ِRefuse to sign the informed consent by the parents history of diabetes mellitus mental retardation obesity (body mass index N95th percentile for age and sex intake of antiemetic within 24 hours before surgery intake of psychoactive medication within 24 hours before surgery known gastroesophageal reflux. Inaccessibility of patient for follow-up R11 Nausea and vomiting Prevention Prevention Intervention group: (superhydration) Ringer lactate infusion 30cc/kg at the time of operation Control group: Infusion of 10cc/kg Lactated Ringer during surgery Postoperative nausea and vomiting. Timepoint: in recovery room, 12 hours and 24 hours after surgery. Method of measurement: question from patient or parents. Requested antiemetic dose in first 24 hours after surgery. Timepoint: Aّt first 24 hours after surgery. Method of measurement: Evaluation of patients file and recording in questionnaire. Hamedan University of Medical Sciences Approved 2018-10-09 Committee of Ethics in Research, Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan Hamadan Hamadan Iran (Islamic Republic of)