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

NCT ID: NCT05667727

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2025-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

epinephrine group

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

Group Type: EXPERIMENTAL

nebulized epinephrine

Intervention Type: DRUG

we are using 1:1000 epinephrine into nebulization form

control group

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

Group Type: ACTIVE_COMPARATOR

Salbutamol

Intervention Type: DRUG

Patient will receive salbutamol as 4th nebulization.

Interventions

nebulized epinephrine

we are using 1:1000 epinephrine into nebulization form

Intervention Type: DRUG

Salbutamol

Patient will receive salbutamol as 4th nebulization.

Intervention Type: DRUG

Other Intervention Names

The control

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oman Medical Speciality Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Adnan Juma Al Rawahi

Emergency Medicine Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Royal Hospital

Muscat, , Oman

Countries

Oman

Other Identifiers

R2016

Identifier Type: -

Identifier Source: org_study_id