Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children

Makassed General Hospital

Status: Completed

Conditions: Respiratory Distress Score

Treatments: Drug: Salbutamol; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03814954

1812182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children diagnosed with acute bronchiolitis.

Exclusion criteria

• Children with congenital heart disease or
• chronic lung diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Salbutamol

Active Comparator group

Description:

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

Treatment:

Drug: Salbutamol

Epinephrine

Experimental group

Description:

Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.

Treatment:

Drug: Epinephrine