Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
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|ClinicalTrials.gov Identifier: NCT03814954|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Score||Drug: Salbutamol Drug: Epinephrine||Not Applicable|
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:
Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||February 15, 2020|
Active Comparator: Salbutamol
Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
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
Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer.
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
- Length of stay [ Time Frame: 5 days ]Patients hospitalization duration will be recorded
- Respiratory distress scoring [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814954
|Contact: Mariam A Rajab, MD||+9611636000 ext firstname.lastname@example.org|
|Makassed General Hospital||Recruiting|
|Contact: Mariam Rajab, MD +9611636000 ext 6317 email@example.com|
|Principal Investigator:||Mariam Rajab, MD||Makassed General Hospital|