NCT05667727

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Oman Medical Speciality Board · Other Government
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size. Patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization. PRAM score with calculated before and at 60, 80, 100 min after the treatment.

Conditions

• Shortness of Breath
• Asthma in Children
• Epinephrine Causing Adverse Effects in Therapeutic Use
• Salbutamol Adverse Reaction

Interventions

Type	Name	Description
DRUG	nebulized epinephrine	we are using 1:1000 epinephrine into nebulization form
DRUG	Salbutamol	Patient will receive salbutamol as 4th nebulization.

Timeline

• Start date: 2023-10-15
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2022-12-29
• Last updated: 2025-06-06

Locations

1 site across 1 country: Oman