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Trials / Completed

CompletedNCT03814954

Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Makassed General Hospital · Academic / Other
Sex
All
Age
1 Month – 24 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSalbutamolAt 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
DRUGEpinephrineAt 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

Timeline

Start date
2019-01-01
Primary completion
2021-08-31
Completion
2021-08-31
First posted
2019-01-24
Last updated
2022-08-30

Locations

1 site across 1 country: Lebanon

Source: ClinicalTrials.gov record NCT03814954. Inclusion in this directory is not an endorsement.