Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children

Not Applicable

Completed

• Conditions: Respiratory Distress Score
• Interventions: Drug: Epinephrine; Drug: Salbutamol

• Registration Number: NCT03814954
• Lead Sponsor: Makassed General Hospital

Brief Summary

Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.

Detailed Description

The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study.

Children who meet the inclusion criteria will be alternately distributed in two groups:

Group 1:

Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

Group 2:

Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation.

Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-24
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-28
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Children diagnosed with acute bronchiolitis.

Exclusion Criteria

• Children with congenital heart disease or
• chronic lung diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epinephrine	Epinephrine	Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
Salbutamol	Salbutamol	Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.

Primary Outcome Measures

Name	Time	Method
Length of stay	5 days	Patients hospitalization duration will be recorded

Secondary Outcome Measures

Name	Time	Method
Respiratory distress scoring	5 days	The score will be measured through Silverman-Andersen Retraction scoring. The minimum score is 0 indicating no distress. The maximum score is 10 indicating severe respiratory distress

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon