A Phase 4 interventional study of nebulized epinephrine and Salbutamol in Shortness of Breath, Asthma in Children and Epinephrine Causing Adverse Effects in Therapeutic Use, sponsored by Oman Medical Speciality Board. Completed at 1 site in Oman. Open to participants aged 3 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Oman Medical Speciality Board · Phase 4, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Oman Medical Speciality Board is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric age group 3 - 12 years
History of lung or upper airway disease other than asthma:
this arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization.
Drug: nebulized epinephrine
in this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization.
Drug: Salbutamol
we are using 1:1000 epinephrine into nebulization form
Patient will receive salbutamol as 4th nebulization.
Also known as: The control
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
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Oman Medical Speciality Board