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IRCT20200809048343N1 IRCT 2020-11-13 Kashan University of Medical Sciences Comparison of the effect of Dexamethasone and Ondansetron on nausea , vomiting and delirium in children undergoing upper GI endoscopy Comparison of the effect of Dexamethasone and Ondansetron on nausea,vomiting and delirium in children undergoing upper GI endoscopy 2020-08-22 anticipated 60 Complete https://irct.ir/trial/50291 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, the group receiving dexamethasone was coded with the letter A, the group receiving ondansetron with the letter B and the control group with the letter C, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists Randomization list was prepared by selecting a sample size of 60 (three groups of 30) and Permuted block randomization method (block size=6) (10 blocks of 6). Then, through the obtained randomization list, the subjects will be assigned to one of the three groups A or B or C. For example, suppose that in the first six blocks, the permutation method is AABCBC, so the first and second samples are group A (dexamethasone), the third and fifth samples are group B (ondansetron), and the fourth and sixth samples are Group C (control) will be assigned and the same will continue until the last sample (60th person), Blinding description: In this study, participants did not know how to work and prescribe drugs. 3 dyspepsia. Intervention 1: Intervention group: In the dexamethasone group, 0.1 mg / kg dexamethasone is injected when the anesthesia level is sufficient. Intervention 2: Intervention group: In the ondansetron group, 0.15 mg / kg of ondansetron is injected when the anesthesia level is sufficient. Intervention 3: Control group: In the control group, no drug is injected. 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 Its release schedule is not yet known
public Dr.Mahsa Nassaj
Amir Kabir Street
Kashan Iran (Islamic Republic of) 8718646351 +98 31 5534 0342 mahsa.nassaj87@gmail.com Kashan University of Medical Sciences scientific Dr.Ramin Madani
Qutb Ravandi Boulevard
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5531 7889 drraminmadani@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Children 5 to 14 years old who are candidates for UGIE with deep anesthesia ASA stage : 1 , 2 Modified APFEL score 0 , 1 5 years 14 years Both History of allergies to the drugs used in the study History of previous chemotherapy History of malignancy History of metabolic disease History of diabet Upper respiratory tract anatomical disease Treatment with Psychiatric drugs/Behavioural disorder Children who have received sedatives before the procedure. Children who are candidates for ERCP or emergency endoscopy Children who receive higher doses of the drug due to the difficulty of the operation to prolong the duration of anesthesia R10.1 Dyspepsia NOS /Epigastric pain Prevention Prevention Other Intervention group: In the dexamethasone group, 0.1 mg / kg dexamethasone is injected when the anesthesia level is sufficient. Intervention group: In the ondansetron group, 0.15 mg / kg of ondansetron is injected when the anesthesia level is sufficient. Control group: In the control group, no drug is injected. Percentage of people with nausea and vomiting. Timepoint: Existence of nausea-vomiting after the intervention. Method of measurement: view. Intensity of delirium in individuals. Timepoint: Measurement of delirium severity after intervention (during recovery). Method of measurement: PAED Scaling Score. Kashan University of Medical Sciences Approved 2020-07-13 Ethics committee of Kashan University of Medical Science 3 km of Ravand road, Physician Boulevard., Medical School Kashan Isfehan Iran (Islamic Republic of)