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IRCT20190106042260N2 IRCT 2020-06-02 Iran University of Medical Sciences Evaluation of the effect of inhaled budesonide (Pulmicort) on children with acute asthma attack Evaluation of the effect of inhaled budesonide (Pulmicort) on children with acute asthma attack in patients referred to Ali Asghar Children's Hospital 2020-03-20 anticipated 80 Complete https://irct.ir/trial/48557 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted Block Randomization will be use and the number of two control and test groups will be equal so that in each group, 4, 8, 10, and 12 Blocks are used, and the volume of each group is 40, and in total will be 80 patients. Allocation Concealment: In sealed envelopes, a random sequence is mentioned on the envelope and given to the nurse, and the doctor and patient are not informed about the details, Blinding description: The sealed envelope is in the hands of the nurse of the triage or ward for the selection of the drug or placebo, and is randomly assigned to the patients, respectively. The drug with a placebo is drawn in the same form by the triage nurse in the syringe and used in a nebulizer. 3 Acute asthma attack in pediatric. Intervention 1: Intervention group: Children with an acute asthma attack receive the basic treatment for an asthma attack and will also receive an inhaled budesonide (Pulmicort). Ventolin dose will be 0/03 ml (0/15 mg) per kg (minimum 0/5 ml [2/5 mg], maximum 0/1 ml [5 mg]) . Intravenous hydrocortisone dose will be 40 mg/kg /d, and the dose of Pulmicort will be 0/25 mg inhaled every 6 hours, up to 4 times a day for a maximum of 1 mg daily throughout the hospitalization period. Intervention 2: Control group: Children with an acute asthma attack receive the basic treatment for an asthma attack and will also receive a 3 cc normal saline as a placebo. Ventolin dose will be 0/03 ml (0/15 mg) per kg (minimum 0/5 ml [2/5 mg], maximum 0/1 ml [5 mg]) . Intravenous hydrocortisone dose will be 40 mg/kg /d. Yes - There is a plan to make this available What will be shared: This study will be performed as a clinical trial (Phase 3) and Double-Blinded type, in two groups of control and intervention and with drugs approved by the Food and Drug Administration and common in the pharmaceutical market, and the results can be shared. When: After publishing the article To whom: Researchers, doctors Conditions: This study is a small-scale, pilot study, and is expected to be investigated with a bigger sample size after termination. Where to obtain: Rozhin pahlevani's Email Addresses: Pahlevan.r@iums.ac.ir Rozhin.pahlevan@gmail.com Rozhin_p92Yahoo.com How to obtain: Once the article is published, applicants can receive information about the data through the email addresses provided. Comments:
public Rozhin Pahlevani
No19, Elahieh complex, End of koohsar BLV.,Shahran,Tehran
Tehran Iran (Islamic Republic of) 1488874645 +98 21 4431 9829 rozhin.pahlevan@gmail.com Iran University of Medical Sciences scientific Rozhin Pahlevani
No. 4, Elahie 19, Elahie complex, End of koohsar Blvd., Shahran
Tehran Iran (Islamic Republic of) 1488874645 +98 21 4431 9829 Pahlevan.r@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosed as asthma by doctor Lack of other chronic and specific diseases Diagnosis as acute asthma attack by doctor Age range Between 2-12 years old 2 years 12 years Both A child with heart disease Lack of willingness to participate in the study Have chronic lung disease other than asthma Children who have received specific steroid medications over the past 7 days J45 Asthma Treatment - Drugs Placebo Intervention group: Children with an acute asthma attack receive the basic treatment for an asthma attack and will also receive an inhaled budesonide (Pulmicort). Ventolin dose will be 0/03 ml (0/15 mg) per kg (minimum 0/5 ml [2/5 mg], maximum 0/1 ml [5 mg]) . Intravenous hydrocortisone dose will be 40 mg/kg /d, and the dose of Pulmicort will be 0/25 mg inhaled every 6 hours, up to 4 times a day for a maximum of 1 mg daily throughout the hospitalization period. Control group: Children with an acute asthma attack receive the basic treatment for an asthma attack and will also receive a 3 cc normal saline as a placebo. Ventolin dose will be 0/03 ml (0/15 mg) per kg (minimum 0/5 ml [2/5 mg], maximum 0/1 ml [5 mg]) . Intravenous hydrocortisone dose will be 40 mg/kg /d. Cough rate. Timepoint: 6,12,24,48 hours after the interventions. Method of measurement: Based on mild / moderate / severe. Weezing score. Timepoint: 6,12,24,48 hours after the interventions. Method of measurement: Based on a score of 0 to 3/ without, in inhalation, in exhalation, Both. Workup Breathing. Timepoint: 6,12,24,48 hours after the interventions. Method of measurement: Based on mild / moderate / severe. Duration of hospitalization. Timepoint: The number of hospitalization days. Method of measurement: According to the number of days. Respiratory rate. Timepoint: 6,12,24,48 hours after the interventions. Method of measurement: Based on mild / moderate / severe. Possible complication. Timepoint: During the hospitalisation. Method of measurement: Based on drug side effects. Iran University of Medical Sciences Approved 2020-05-20 Ethics committee of Iran University of Medical Sciences No4, Elahieh 19, Elahieh Complex, end of Kuhsar Blvd, shahran, tehran,Iran Tehran Tehran Iran (Islamic Republic of)