The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial

R2016

Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects. It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient. A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.

2023-10-15

2025-06-01

2025-06-01

Recruiting

Early phase I

30

* Inclusion Criteria: * Pediatric age group 3 - 12 years * known to have asthma * Initial PRAM Score showed moderate to severe asthma exacerbation * Exclusion Criteria: * History of lung or upper airway disease other than asthma: * bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreign body aspiration, bronchopulmonary dysplasia, cystic fibrosis and lower airway mass effects * History of congenital heart disease or cardiac arrhythmia or heart failure. * Known hypertension * Impending respiratory failure (Decreasing mental status, Respiratory fatigue, Impending respiratory arrest, Hypoxemia (pO2 \< 60 mmHg), pCO2 could be normal or high) * Allergy or hypersensitivity to epinephrine * Patient/Parents refusal to participate in the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'both groups will receive salbutamol and ipratropium as back to back nebulization for 3 times. Then the candidate will be randomized into experimental group (epinephrine nebulization) and the control group (salbutamol nebulization as 4th nebulization)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'the clinical pharmacist will label the medications according to coding system. 2 boxes will be available, one for weight less than 20kg and other box for patient weight more than or equal of 20 kg. Both boxes will contain both medications (epinephrine and salbutamol) in identical syringe with the same volume.\n\nThe patient, physician and the nurse will be blinded to the 4th nebulization (experimental intervention)\n\nOnce patient get enrolled in the study and received the standard of care (back to back nebulization), the nurse with take the experimental intervention according to the weight and the coding which been done the pharmacist.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-04-09