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IRCT20190202042583N3 IRCT 2021-09-01 Mazandaran University of Medical Sciences The effect of zinc gluconate mouthwash in prevention of mucositis , The effect of zinc gluconate mouthwash in prevention of mucositis , following the administration of high doses of methotreoxate in children with acute lymphoblastic leukemia 2019-06-22 anticipated 100 Complete https://irct.ir/trial/50256 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We divide each client into two groups using a random table. This table is a set of numbers. Consider the numbers 1 to 30 for intervention A and the numbers 31 to 60 for control B (for both size groups larger and smaller than 4 cm). Then we touch one of the numbers and move into one of the predetermined directions and record the numbers and assign them to one of the groups. In this way, patients are divided completely randomly, Blinding description: Each patient will be informed by the dentist prior to receiving the drug in terms of the severity and severity of the mucositis. The dentist will not be aware of the patient who is rejected (case or control). For the patient, starting with the 24-hour infusion, methotrexate is given every 8 hours for mouthwash and at least 30 seconds for oral mouthwash.In the control group, the patient receives a standard oral mucosa (containing 100,000 units of nystatin in a cc + diphenhydramine 2.5 mg per cc + 260 cc of MG aluminum syringe). The case group in each patient uses the same oral mucosal epizood in the same container containing the above plus 1mili grams in cc of zinc gluconate, The above mouthwash is prepared in coordination with the pharmacy department of the pharmacy of Bu Ali Hospital in Sari and under the supervision of the pharmacist's colleague, Dr. Sahraei. Patients are not aware of the type of mouthwash in each patient-episode The nurse in the oncology department monitors the proper use of mouthwash and, if not properly used, to be excluded from the study. 3 Acute Lymphoblastic Leukemia. Intervention 1: Intervention group: Each patient is evaluated for the presence and severity of mucositis before receiving the drug by the dentist. For the patient, mouthwashWhich is performed every 8 hours from the start of the 24-hour infusion of methotrexate which prepared in Mazandaran School of Pharmacy and keeping the mouthwash in the mouth for at least 30 seconds.In the intervention group, each patient uses mouthwash in the same container containing the above plus 1 mg / cc zinc gluconate Which has been prepared by the design consultant pharmacistin the same way. The patients studied are not aware of the type of mouthwash used in each patient-episode. In both groups, the number of nausea and vomiting and daily food intake are recorded.Patients are re-examined on the 4th day after the start of methotrexate by a partner dentist and the mucositis is registered according to the criteria of the World Health Organization. Intervention 2: Control group: Each patient will be co-supervised by the dentist prior to receiving the drug in terms of the existence and severity of mucositis. The patient is given a mouthwash at least 30 seconds after starting the 24-hour infusion of methotrexate Which was prepared in Mazandaran School of Pharmacy every 8 hours for mouthwash In both groups, the frequency of nausea and vomiting and Food intakes are recorded daily. People again on day 4 after starting methotrexate are checked out by a dentist who is a collaborator and mocositis is recorded according to the WHO criteria. If mucositis is present, again, on the 7th day, a dentist will examine the presence and severity of mucositi. 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 The results will be published later
public Mohammad Naderisorki
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 7837 dr.naderisorki@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammad Naderisorki
Bou Ali Sina Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 902 604 2132 dr.naderisorki@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age between 5 to 15 years old Acute Lymphoblastic Leukemia under the treatment of Children's Oncology Group (COG) chemotherapy protocol High dose of methotrexate No mucositis before receiving methotrexate No nausea and vomiting before starting methotrexate Platelet count above 100,000 per μl before From the onset of methotrexate The absolute neutrophil count exceeds 1500 ml / μl before starting methotrexate Hemoglobin above 8 g / l Before starting methotrexate, the ability to use mouthwash for 30 seconds every 8 hours 5 years 15 years Both Presence of fever Use of systemic or topical antibiotics C91.0 Acute lymphoblastic leukemia [ALL] Treatment - Drugs Placebo Intervention group: Each patient is evaluated for the presence and severity of mucositis before receiving the drug by the dentist. For the patient, mouthwashWhich is performed every 8 hours from the start of the 24-hour infusion of methotrexate which prepared in Mazandaran School of Pharmacy and keeping the mouthwash in the mouth for at least 30 seconds.In the intervention group, each patient uses mouthwash in the same container containing the above plus 1 mg / cc zinc gluconate Which has been prepared by the design consultant pharmacistin the same way. The patients studied are not aware of the type of mouthwash used in each patient-episode. In both groups, the number of nausea and vomiting and daily food intake are recorded.Patients are re-examined on the 4th day after the start of methotrexate by a partner dentist and the mucositis is registered according to the criteria of the World Health Organization. Control group: Each patient will be co-supervised by the dentist prior to receiving the drug in terms of the existence and severity of mucositis. The patient is given a mouthwash at least 30 seconds after starting the 24-hour infusion of methotrexate Which was prepared in Mazandaran School of Pharmacy every 8 hours for mouthwash In both groups, the frequency of nausea and vomiting and Food intakes are recorded daily. People again on day 4 after starting methotrexate are checked out by a dentist who is a collaborator and mocositis is recorded according to the WHO criteria. If mucositis is present, again, on the 7th day, a dentist will examine the presence and severity of mucositi Severity of Mucositis. Timepoint: Before receiving the drug and re-day four after the onset of methotrexate. Method of measurement: By the dentist and according to the Criteria WHO. Periods of Mucositis. Timepoint: Before receiving the drug and re-day four after the onset of methotrexate. Method of measurement: By the dentist and according to the Criteria WHO. Mazandaran University of Medical Sciences Approved 2020-04-04 Ethics committee of Mazandaran University of Medical Sciences Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari Sari Mazandaran Iran (Islamic Republic of)