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

Oman Medical Speciality Board

Status and phase: Completed; Phase 4

Conditions: Shortness of Breath; Asthma in Children; Salbutamol Adverse Reaction; Epinephrine Causing Adverse Effects in Therapeutic Use

Treatments: Drug: Salbutamol; Drug: nebulized epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT05667727

R2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

epinephrine group

Experimental group

Description:

this arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization.

Treatment:

Drug: nebulized epinephrine

control group

Active Comparator group

Description:

in this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization.

Treatment:

Drug: Salbutamol