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IRCT20150119020715N6 IRCT 2018-06-23 Arak University of Medical Sciences The Effect of an Oral Medicine on Nausea and Vomiting Caused by Chemotherapy in Children With Cancer. Evaluation the Effect of Olanzapine on the Nausea and Vomiting Induced by Chemotherapy in Children with Malignancy. 2018-05-21 anticipated 60 Complete https://irct.ir/trial/30753 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomization we will use the block method, based on this, two lists of patients are provided and each list is placed in one of the groups, Blinding description: In this study, patient , the statistical analyst and physician are blind for study group. In order to blind the patient, two lists are provided and based on the number of patient admission who is pairs or single, he were take on one of these lists. In order to blind the statistical analyst, information is generally presented in two groups, and he does not have any information about the intervention and control groups. Also, the physician have not any information about two groups, accordingly, use for patients medication or similar placebo. 3 Nausea and vomiting. Intervention 1: Intervention group: 5 mg olanzapine tablets are used at a dose of 0.1 mg / kg PO per 24 hours (based on the weight at a maximum dose of 10 mg per day). Intervention 2: Control group: Similar placebo in control group used as triple-blind. 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 There are no more information.
public Aziz Eghbali
3819693345, Amir-Kabir Hospital, Basij Square, Arak, Iran
Arak Iran (Islamic Republic of) 3819693345 +33 135075 dr.eghbali@arakmu.ac.ir Arak University of Medical Sciences scientific Aziz Eghbali
3819693345, Amir-Kabir Hospital, Basij Square, Arak, Iran
Arak Iran (Islamic Republic of) 3819693345 +33 135075 dr.eghbali@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Children aged 5 to 15 years of age who have recently diagnosed as malignancy Indication of chemotherapy, based on assessment, diagnosis and approval by physician On the first day of chemotherapy, they should have a RAS score more than 20. 5 years 15 years Both Diseases that triggers the nausea and vomiting Inability to express the severity of nausea and vomiting Patients who has not satisfied with the study Olanzapine drug complications R11 Nausea and vomiting Treatment - Drugs Placebo Intervention group: 5 mg olanzapine tablets are used at a dose of 0.1 mg / kg PO per 24 hours (based on the weight at a maximum dose of 10 mg per day). Control group: Similar placebo in control group used as triple-blind Nausea and vomiting. Timepoint: Before starting chemotherapy, 24 hours after chemotherapy and 5 days after chemotherapy. Method of measurement: To evaluate the state of nausea and vomiting in patients, RAS criteria will be used to measure the state of nausea and vomiting in patients from 1 to 100. Arak University of Medical Sciences Approved 2018-02-10 Ethics committee of Arak University of Medical Sciences Sardasht Arak Markazi Iran (Islamic Republic of)