Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children

Respiratory Distress Score Clinical Trial

Official title:

Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814954
• Other study ID #: 1812182
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2022
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

Inclusion Criteria:

• Children diagnosed with acute bronchiolitis.

Exclusion Criteria:

• Children with congenital heart disease or

• chronic lung diseases

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Distress Score

Intervention

Drug:
• Salbutamol
At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
• Epinephrine
At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Patients hospitalization duration will be recorded	5 days
Secondary	Respiratory distress scoring	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	5 days