The effect of zinc gluconate mouthwash in prevention of mucositis , following the administration of high doses of methotreoxate in children with acute lymphoblastic leukemia

The effect of zinc gluconate in prevention of mucositis, following a high dose of methotrexate in children with acute lymphoblastic leukemia

Clinical trial with control group, double-blind and randomized

Patients with acute lymphoblastic leukemia who are admitted to the pediatric oncology ward and are being treated with a high dose of methotrexate. For the patient, mouthwash should be performed every 8 hours from the start of the 24-hour methotrexate infusion and kept in the mouth for at least 30 seconds. In the intervention group, 1 mg zinc gluconate is added to the above solution. The studied patients and the design dentist who is in charge of the post-treatment examination are not aware of the type of mouthwash used in each patient-episode

Inclusion criteria: Age of 5 to 15 years, ALL,treated by high dose of methotrexate, no mucositis before receiving methotrexate, no nausea and vomiting before starting methotrexate exclusion criteria:presence of fever, use of systemic or topical antibiotics

Patients from 5 to 10 years old children with ALL who are treated with a high dose of intravenous methotrexate (5 g / 24 hours infusion). In the control group, the patient receives a standardized oral mucosa (containing 100,000 units nystatin per cc + diphenhydramine 2.5 mg per cc + 260 cc MG aluminum syrup). The case group in each patient-the mouthpiece episode in the same container containing the above plus 1grams in cc of zinc gluconate is used similarly.

The presence of mucositis، Mucositis intensity، Mucositis period، Number of nausea، The number of vomiting times، Number of feeds of fluids، The frequency of feeding solids

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.

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