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Clinical Trial Summary

Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects. It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient. A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.


Clinical Trial Description

Because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size. Patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization. PRAM score with calculated before and at 60, 80, 100 min after the treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05667727
Study type Interventional
Source Oman Medical Speciality Board
Contact Adnan Al-Rawahi, Resident
Phone 00968 95576483
Email r2016@resident.omsb.org
Status Recruiting
Phase Phase 4
Start date October 15, 2023
Completion date June 1, 2025

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