]>
IRCT20220119053760N2 IRCT 2022-12-28 Esfahan University of Medical Sciences evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in children A randomized Clinical trial to evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in 2-12years old children 2022-12-22 anticipated 68 Complete https://irct.ir/trial/67386 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples were selected as available from Imam Hossein Hospital of Isfahan. Then, completely randomly and based on the children's national number, using spss software, they were randomly assigned to two intervention and placebo groups. After the child entered the hospital, if the entry and exit criteria were met, the children's national number was registered in the software and by choosing the exact ratio of 50% of the children, they were assigned to two randomized groups, Blinding description: Both groups received the standard drug. In the intervention group, in addition to the standard drug, montelukast nasal was used, and in the placebo group, placebo was used in the same amount and the same appearance of the drug. 2-3 Severe asthma attack. Intervention 1: Intervention group: Intranasal Montelukast drug using Montelukast powder from Aldrich Company, carboxymethyl cellulose as a suspending agent, methylparaben and propylparaben as antimicrobial and antifungal preservatives and phosphate buffer to adjust ph by a clinical pharmacy specialist in the faculty laboratory. Pharmacy of Isfahan University of Medical Sciences is prepared and given to the patient in a special package as a spray with a fixed dose inside the nose. The drug is used once a day. Intervention 2: Control group: The combination of carboxymethyl cellulose as a suspending agent, methyl paraben and propyl paraben as an antimicrobial and antifungal preservative and a phosphate buffer to adjust pH was prepared by a clinical pharmacy specialist in the laboratory of the Faculty of Pharmacy of Isfahan University of Medical Sciences and packaged in a special spray form. It is given to the patient with a fixed intranasal dose. The drug is used once a day. Yes - There is a plan to make this available What will be shared: Information and data will be available to applicants one year after obtaining the results. When: Information and data will be available to applicants one year after obtaining the results. To whom: Doctors Conditions: Comparison of new drug combination with another new drug Where to obtain: Send a message to dean@med.mui.ac.ir How to obtain: Send a message to dean@med.mui.ac.ir Comments:
public Dr. Morteza Sadi Nejad
Imam Hossein Children's Hospital, Imam Khomeini St
Isfahan Iran (Islamic Republic of) 3759153111 +98 913 787 7646 n.abrishami@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Neda Abrishami
Isfahan University of Medical Sciences, School of Medicine
Isfahan Iran (Islamic Republic of) 817671111 +98 31 3778 8089 n.abrishami@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children 2 to 12 years old Hospitalization due to an acute asthma attack with a pulmonary index score (PIS) between 7 and 11 (moderate attack) or a score greater than 12 (severe attack) 2 years 12 years Both Simultaneous treatment with systemic corticosteroids or antileukotrienes within 4 weeks before admission Other possible causes for the patient's symptoms such as pneumonia Having a history of chronic lung diseases and anatomical airway problems and congenital heart disease History of taking anticonvulsant and immunosuppressive drugs J45.5 Severe persistent asthma Treatment - Drugs Diagnosis Intervention group: Intranasal Montelukast drug using Montelukast powder from Aldrich Company, carboxymethyl cellulose as a suspending agent, methylparaben and propylparaben as antimicrobial and antifungal preservatives and phosphate buffer to adjust ph by a clinical pharmacy specialist in the faculty laboratory. Pharmacy of Isfahan University of Medical Sciences is prepared and given to the patient in a special package as a spray with a fixed dose inside the nose. The drug is used once a day. Control group: The combination of carboxymethyl cellulose as a suspending agent, methyl paraben and propyl paraben as an antimicrobial and antifungal preservative and a phosphate buffer to adjust pH was prepared by a clinical pharmacy specialist in the laboratory of the Faculty of Pharmacy of Isfahan University of Medical Sciences and packaged in a special spray form. It is given to the patient with a fixed intranasal dose. The drug is used once a day. The severity of the asthma attack. Timepoint: On the first day of hospitalization, every 4 hours and on the following days of hospitalization, once a day, patients based on PIS score (pulmonary index score). Method of measurement: According to the reference, a moderate attack is defined based on the need for auxiliary oxygen-nebulizer albuterol and systemic glucocorticoid, and a severe attack is defined based on the need for auxiliary oxygen-nebulizer salbutamol and ipratropium-systemic glucocorticoid-magnesium sulfate. Esfahan University of Medical Sciences Approved 2022-05-11 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences , Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)