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

Last updated: June 3, 2025
Sponsor: Oman Medical Speciality Board
Overall Status: Completed

Phase

4

Condition

Asthma

Treatment

Salbutamol

nebulized epinephrine

Clinical Study ID

NCT05667727
R2016
  • Ages 3-13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • Inclusion Criteria:

  • Pediatric age group 3 - 12 years

  • known to have asthma

  • Initial PRAM Score showed moderate to severe asthma exacerbation

Exclusion

  • Exclusion Criteria:

  • History of lung or upper airway disease other than asthma:

  • bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreignbody aspiration, bronchopulmonary dysplasia, cystic fibrosis and lowerairway 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 normalor high)

  • Allergy or hypersensitivity to epinephrine

  • Patient/Parents refusal to participate in the study

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Salbutamol
Phase: 4
Study Start date:
October 15, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Royal Hospital

    Muscat,
    Oman

    Site Not Available

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