]>
IRCT20220508054776N1 IRCT 2023-11-07 Ghoum University of Medical Sciences The effect of oral montelukast in controlling acute asthma attacks in children Evaluation of the effect of adding oral Montelukast to standard treatment in controlling of acute asthma attacks in pediatrics 2024-02-29 anticipated 90 Complete https://irct.ir/trial/73420 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Addition of oral montelukast to the standard treatment of acute asthma attack in children, Randomization description: Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website, Blinding description: The special codes created by the website are assigned to the patients and provided to the therapists, and neither the patient nor the therapist knows whether the oral medication that is given to the patient in addition to the standard treatment is Montelukast or a placebo, both medications. It is produced in tablet form by Airocast. 3 Acute asthma attack. Intervention 1: Case group: Children aged 13-5 years will receive 5 mg of oral memontelocut as a single dose in addition to standard primary treatment. Intervention 2: Control group:2. The control group consists of children who will receive standard treatment along with 5 mg of placebo provided by Airocast company to control asthma attacks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts from September 2024 To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: A letter to the Vice-Chancellor of Medical Sciences Research, Qom Where to obtain: Seyyed Salman Moosavinejad How to obtain: One Month Comments:
public Seyed Salman Moosavinejad
Hazrat Masoumeh Hospital, Zainuddin Square, Qom
Qom Iran (Islamic Republic of) 3713649373 +98 25 3162 5224 salman.moosavi1234@gmail.com Ghoum University of Medical Sciences scientific Seyed Salman Moosavinejad
Hazrat Masoumeh Hospital, Zainuddin Square, Qom
Qom Iran (Islamic Republic of) 3713649373 +98 25 3162 5224 salman.moosavi1234@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Children aged 5-13 years Children with an acute asthma attack 5 years 13 years Both Parents' lack of consent to participate in the study The child's heart, lung, and metabolic diseases Children under 5 years old and over 13 years old History of anti-leukotriene use in the last two weeks Children who need intubation for treatment J45.50 Severe persistent asthma Treatment - Drugs Treatment - Drugs Case group: Children aged 13-5 years will receive 5 mg of oral memontelocut as a single dose in addition to standard primary treatment. Control group:2. The control group consists of children who will receive standard treatment along with 5 mg of placebo provided by Airocast company to control asthma attacks.. PEF. Timepoint: PEF measurement on arrival and 6 hours later. Method of measurement: Picoflowmeter device. The effect of adding oral montelukast to standard treatment on patient's blood oxygen. Timepoint: Upon arrival and 6 hours later. Method of measurement: with pulse oximeter. Effect of adding oral montelukast to standard treatment on vital signs. Timepoint: Upon arrival and 6 hours later. Method of measurement: Examination of the patient by a doctor. Effect of adding oral montelukast to standard treatment on respiratory distress. Timepoint: Upon arrival and 6 hours later. Method of measurement: Examination of the patient by a doctor. Ghoum University of Medical Sciences Approved 2022-05-10 Ethics Committee of Qom University of Medical Sciences Qom,Iran Qom Ghoum Iran (Islamic Republic of)