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

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

The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment With Placebo

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.

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, the experimental group which include salbutamol (standard dose), ipratropium bromide (standard dose) along with epinephrine (1ml of 1:1000) to given as nebulization. The other group with given the standard treatment with the same doses with epinephrine. PRAM score with calculated before and at 20, 40, 90 min after the treatment.

Shortness of Breath, Asthma in Children, Epinephrine Causing Adverse Effects in Therapeutic Use, Salbutamol Adverse Reaction

one group will receive (salbutamol and ipratropium) + nebulized epinephrine and the other group will receive (salbutamol and ipratropium) + placebo (normal saline)

the clinical pharmacist will label the medications according to coding system, every new patient will be assessed by the treating physician then the staff nurse will provide the intervention (she will known the medication), both participant and the treating physician will be masked.

this arm will include the participant who will receive the epinephrine plus the standard treatment (salbutamol and ipratropium)

in this arm, participant will receive the placebo (normal saline) plus the standard treatment (salbutamol and ipratropium)

the control group will receive Normal saline (placebo) plus the standard treatment (salbutamol and ipratropium)

treating physician will calculate the PRAM score before and immediately after the intervention by 20 mins, if there is no change in PRAM score or the case worsen, candidate will receive further treatment, but if he/she improved, will be assessed in the second interval.

immediately after the intervention by 40 mins, candidate will be assessed, calculating the PRAM score again, and decide he/she will need further treatment or to continue observation.

immediately after the intervention by 90 mins, candidate will be assessed again, calculating the PRAM score and decide about if he will need further treatment or no. Total observation will be almost 2 hours in order to look for other outcome as well.

"during the assessment", after the exposure This outcome will be decided upon each reassessment intervals, at any time during assessment if there is no change in PRAM score or worsening patient will receive further treatment as decided before and his enrollment in the study will be ended here.

"during the assessment" this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home.

"during the assessment" Each candidate will be assessed throughout the enrolment in the study, starting from the administration of the medication till 2 hours post exposure.

Inclusion Criteria: Age between 3 and 13 years old Pre-existing diagnosis of asthma Presenting to the ED with an asthma exacerbation Exclusion Criteria: History of chronic lung or upper airway disease other than asthma History significant, uncorrected congenital heart disease or cardiac arrhythmia Impending respiratory failure Allergy to epinephrine