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

NCT05667727 | Completed Phase 4

• 1 other identifier: R2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Emergency Department (ED) length of stay

  from the randomization up to 4 hours

• The rate for admission

  from the randomization up to 4 hours

• rate of any side effect of nebulized epinephrine

  from the randomization up to 4 hours

• The need for respiratory support (O2, Non-invasive ventilation, intubation)

  from the randomization to the disposal time

• The rate of revisit to Emergency Department within 72 hours of the index visit

  Till 72 hours post discharge

Study Arms (2)

epinephrine group

EXPERIMENTAL

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

Drug: nebulized epinephrine

control group

ACTIVE COMPARATOR

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

Drug: Salbutamol

Interventions

nebulized epinephrine DRUG

we are using 1:1000 epinephrine into nebulization form

epinephrine group

Salbutamol DRUG

Patient will receive salbutamol as 4th nebulization.

Also known as: The control

control group

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric age group 3 - 12 years
• known to have asthma
• Initial PRAM Score showed moderate to severe asthma exacerbation

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

Royal Hospital

Muscat, Oman

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the clinical pharmacist will label the medications according to coding system. 2 boxes will be available, one for weight less than 20kg and other box for patient weight more than or equal of 20 kg. Both boxes will contain both medications (epinephrine and salbutamol) in identical syringe with the same volume. The patient, physician and the nurse will be blinded to the 4th nebulization (experimental intervention) Once patient get enrolled in the study and received the standard of care (back to back nebulization), the nurse with take the experimental intervention according to the weight and the coding which been done the pharmacist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Resident

Model Details: both groups will receive salbutamol and ipratropium as back to back nebulization for 3 times. Then the candidate will be randomized into experimental group (epinephrine nebulization) and the control group (salbutamol nebulization as 4th nebulization)

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 29, 2022
• Study Start: October 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2024-04

Locations

OM (1)