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NCT05667727
The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment With Placebo Using Improvement PRAM Score as a Primary Outcome
Conditions: Shortness of Breath, Asthma in Children, Epinephrine Causing Adverse Effects in Therapeutic Use, Salbutamol Adverse Reaction
Sex: All
Ages: 3 Years – 13 Years
Phase: PHASE4
Enrollment: 30
Sponsor: Oman Medical Speciality Board
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.
Eligibility Criteria
Inclusion Criteria:Age between 3 and 13 years oldPre-existing diagnosis of asthmaPresenting to the ED with an asthma exacerbationExclusion Criteria:History of chronic lung or upper airway disease other than asthmaHistory significant, uncorrected congenital heart disease or cardiac arrhythmiaImpending respiratory failureAllergy to epinephrine
Source: ClinicalTrials.gov (NCT05667727). StuddyBuddy aggregates publicly available trial information.