Asthma in Children Clinical Trial
Official title:
The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 13 Years |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
Oman | Royal Hospital | Muscat |
Lead Sponsor | Collaborator |
---|---|
Oman Medical Speciality Board |
Oman,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in pediatric respiratory assessment measure (PRAM) score | treating physician will calculate the PRAM score before and immediately after the intervention by 20 mins, if there is no change in PRAM score or the case worsen, candidate will receive further treatment, but if he/she improved, will be assessed in the second interval. | at (60) mints | |
Primary | change in pediatric respiratory assessment measure (PRAM) score | immediately after the intervention by 40 mins, candidate will be assessed, calculating the PRAM score again, and decide he/she will need further treatment or to continue observation. | at (80) mints | |
Primary | change in pediatric respiratory assessment measure (PRAM) score | immediately after the intervention by 90 mins, candidate will be assessed again, calculating the PRAM score and decide about if he will need further treatment or no.
Total observation will be almost 2 hours in order to look for other outcome as well. |
at (100) mints | |
Secondary | Emergency Department (ED) length of stay | "during the assessment", after the exposure
This outcome will be decided upon each reassessment intervals, at any time during assessment if there is no change in PRAM score or worsening patient will receive further treatment as decided before and his enrollment in the study will be ended here. |
from the randomization up to 4 hours | |
Secondary | The rate for admission | "during the assessment"
this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home. |
from the randomization up to 4 hours | |
Secondary | rate of any side effect of nebulized epinephrine | "during the assessment"
Each candidate will be assessed throughout the enrolment in the study, starting from the administration of the medication till 2 hours post exposure. |
from the randomization up to 4 hours | |
Secondary | The need for respiratory support (O2, Non-invasive ventilation, intubation) | "during assessment" | from the randomization to the disposal time | |
Secondary | The rate of revisit to Emergency Department within 72 hours of the index visit | "after discharge" | Till 72 hours post discharge |
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