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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children; Shortness of Breath; Epinephrine Causing Adverse Effects in Therapeutic Use; Salbutamol Adverse Reaction
• Intervention / Treatment: Drug: nebulized epinephrine; Drug: Salbutamol

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Oman
  • Muscat, Oman
    • Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: epinephrine group; this arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization.	Drug: nebulized epinephrine; we are using 1:1000 epinephrine into nebulization form
Active Comparator: control group; in this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization.	Drug: Salbutamol; Patient will receive salbutamol as 4th nebulization.; Other Names: The control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pediatric respiratory assessment measure (PRAM) score	treating physician will calculate the PRAM score before and immediately after the intervention by 20 mins, if there is no change in PRAM score or the case worsen, candidate will receive further treatment, but if he/she improved, will be assessed in the second interval.	at (60) mints
change in pediatric respiratory assessment measure (PRAM) score	immediately after the intervention by 40 mins, candidate will be assessed, calculating the PRAM score again, and decide he/she will need further treatment or to continue observation.	at (80) mints
change in pediatric respiratory assessment measure (PRAM) score	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.	at (100) mints

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department (ED) length of stay	"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.	from the randomization up to 4 hours
The rate for admission	"during the assessment" this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home.	from the randomization up to 4 hours
rate of any side effect of nebulized epinephrine	"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.	from the randomization up to 4 hours
The need for respiratory support (O2, Non-invasive ventilation, intubation)	"during assessment"	from the randomization to the disposal time
The rate of revisit to Emergency Department within 72 hours of the index visit	"after discharge"	Till 72 hours post discharge

Collaborators and Investigators

• Sponsor: Oman Medical Speciality Board

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Signs and Symptoms, Respiratory; Asthma; Dyspnea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Reproductive Control Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Albuterol; Epinephrine
• Other Study ID Numbers: R2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No