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IRCT20181006041252N5 IRCT 2019-01-04 Sabzevar University of Medical Sciences Investigating the effect of standard dose of Albuterol nebulizer, low dose of Albuterol nebulizer with Ipratropium bromide and Albuterol spray on the QT interval in children with moderate to severe asthma. Investigating the effect of standard dose of Albuterol nebulizer, low dose of Albuterol nebulizer with Ipratropium bromide and Albuterol spray on the QT interval in children with moderate to severe asthma. 2018-11-19 anticipated 81 Complete https://irct.ir/trial/36028 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted based on a permutation block, Accordingly, 27 blocks were allocated to patients, in each block, 3 were from following groups, treatment group A, B, and C. Eventually, after completion of the blocks, group A was treated with a standard dose of Albuterol nebulizer, group B was treated with low dose of Albuterol nebulizer with Ipratropium bromide, and group C was treated with albuterol spray, Blinding description: Each person will be assigned a study code A, B, and C, which will only be known to the researcher of the type of groups. The participants are unaware of the groups. 3 Asthma. Intervention 1: Intervention group: Patients use a standard dose of inhaler Albuterol (15 mg/kg, maximal 2.5 mg) twice every 20 minutes to 3 times. Intervention 2: Intervention group: Patients use a combination of low dose Albuterol (0.075 mg/kg, maximal 2.5 mg) and Ipratropium bromide (250 μg) twice every 20 minutes to 3 times. Intervention 3: Intervention group: Patients use an inhaled Albuterol (90 micrograms/kg) twice every 20 minutes to 3 times. 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 No more information
public ِDr. Alireza Asadi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1604 dralirezaasadi@gmail.com Sabzevar University of Medical Sciences scientific ِِDr. Alireza Asadi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1604 dralirezaasadi@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Children aged 6 months to 15 years Children with moderate to severe asthma or pulmonary obstructive disorder are more than 6 months old Children whose forced Expiratory Volume in First Second (FEV1) is less than 80% 6 months 15 years Both Children with heart and kidney disease Children who have received Albuterol treatment for less than 30 days. Children who have used Systemic Corticosteroids in the last week J45 Asthma Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients use a standard dose of inhaler Albuterol (15 mg/kg, maximal 2.5 mg) twice every 20 minutes to 3 times. Intervention group: Patients use a combination of low dose Albuterol (0.075 mg/kg, maximal 2.5 mg) and Ipratropium bromide (250 μg) twice every 20 minutes to 3 times. Intervention group: Patients use an inhaled Albuterol (90 micrograms/kg) twice every 20 minutes to 3 times. QT interval in the electrocardiogram. Timepoint: Electrocardiography (ECG) is performed at the beginning of the study (before the intervention), after the end of the third treatment and 4 hours after the treatment. Method of measurement: Electrocardiography (ECG). Sabzevar University of Medical Sciences Approved 2018-11-19 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)