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

Phase 4

Recruiting

• Conditions: Asthma in Children; Shortness of Breath; Epinephrine Causing Adverse Effects in Therapeutic Use; Salbutamol Adverse Reaction
• Interventions: Drug: nebulized epinephrine; Drug: Salbutamol

• Registration Number: NCT05667727
• Lead Sponsor: Oman Medical Speciality Board

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-29
• Study Start: 2023-10-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epinephrine group	nebulized epinephrine	this arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization.
control group	Salbutamol	in this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization.

Primary Outcome Measures

Name	Time	Method
change in pediatric respiratory assessment measure (PRAM) score	at (100) mints	immediately after the intervention by 90 mins, candidate will be assessed again, calculating the PRAM score and decide about if he will need further treatment or no.; Total observation will be almost 2 hours in order to look for other outcome as well.

Secondary Outcome Measures

Name	Time	Method
rate of any side effect of nebulized epinephrine	from the randomization up to 4 hours	"during the assessment"; Each candidate will be assessed throughout the enrolment in the study, starting from the administration of the medication till 2 hours post exposure.
The rate of revisit to Emergency Department within 72 hours of the index visit	Till 72 hours post discharge	"after discharge"
The need for respiratory support (O2, Non-invasive ventilation, intubation)	from the randomization to the disposal time	"during assessment"
Emergency Department (ED) length of stay	from the randomization up to 4 hours	"during the assessment", after the exposure; This outcome will be decided upon each reassessment intervals, at any time during assessment if there is no change in PRAM score or worsening patient will receive further treatment as decided before and his enrollment in the study will be ended here.
The rate for admission	from the randomization up to 4 hours	"during the assessment"; this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home.

Trial Locations

Locations (1)

Royal Hospital; 🇴🇲 Muscat, Oman