NCT05667727CompletedPhase 4
The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment Using Improvement PRAM Score as a Primary Outcome
The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 15 Oct 2023
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Oman Medical Speciality Board
- Diseases
- Asthma
- NCT number
- NCT05667727
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 30
- From 15 Oct 2023 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 3 years to 13 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Hospital Coordinator of this site? Confirm its status | Muscat | Oman | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.