Nebulized epinephrine for treating asthma in children
The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
This study is testing if nebulized epinephrine can help children with asthma attacks feel better compared to the usual treatment they receive.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 13 Years |
| Sex | All |
| Sponsor | Oman Medical Speciality Board Government |
| Locations | 1 site (Muscat) |
| Trial ID | NCT05667727 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of nebulized epinephrine compared to standard treatment in pediatric patients experiencing asthma exacerbations. It is a double-blinded, randomized control study where participants will receive either nebulized epinephrine or standard treatment after initial care. The primary outcome is the improvement in the Pediatric Respiratory Assessment Measure (PRAM) score, with secondary outcomes including the need for additional management and potential side effects. A pilot study will precede the main trial to determine the necessary sample size.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 12 years with a known diagnosis of asthma and a moderate to severe exacerbation as indicated by their initial PRAM score.
Not a fit: Patients with other significant respiratory or cardiac conditions, or those with allergies to epinephrine, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing asthma exacerbations in children.
How similar studies have performed: This approach is novel, as no previous studies with the same methodology have been found.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Muscat
- Royal Hospital — Muscat, Oman (Recruiting)
Study contacts
- Study coordinator: Adnan Al-Rawahi, Resident
- Email: r2016@resident.omsb.org
- Phone: 00968 95576483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.