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 (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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
we are using 1:1000 epinephrine into nebulization form
Patient will receive salbutamol as 4th nebulization.
Royal Hospital
Muscat, Oman
change in pediatric respiratory assessment measure (PRAM) score
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.
Time frame: at (60) mints
change in pediatric respiratory assessment measure (PRAM) score
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.
Time frame: at (80) mints
change in pediatric respiratory assessment measure (PRAM) score
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.
Time frame: at (100) mints
Emergency Department (ED) length of stay
"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.
Time frame: from the randomization up to 4 hours
The rate for admission
"during the assessment" this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home.
Time frame: from the randomization up to 4 hours
rate of any side effect of nebulized epinephrine
"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.
Time frame: from the randomization up to 4 hours
The need for respiratory support (O2, Non-invasive ventilation, intubation)
"during assessment"
Time frame: from the randomization to the disposal time
The rate of revisit to Emergency Department within 72 hours of the index visit
"after discharge"
Time frame: Till 72 hours post discharge
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