Clinical trial NCT05667727: The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment Using Improvement PRAM Score as a Primary Outcome
Official title: The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shortness of Breath
Asthma in Children
Epinephrine Causing Adverse Effects in Therapeutic Use
Salbutamol Adverse Reaction
Lead sponsor: Oman Medical Speciality Board
Sponsor class: OTHER_GOV
First posted: 2022-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: both groups will receive salbutamol and ipratropium as back to back nebulization for 3 times. Then the candidate will be randomized into experimental group (epinephrine nebulization) and the control group (salbutamol nebulization as 4th nebulization)
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: * Inclusion Criteria:

  * Pediatric age group 3 - 12 years
  * known to have asthma
  * Initial PRAM Score showed moderate to severe asthma exacerbation
* Exclusion Criteria:

  * History of lung or upper airway disease other than asthma:

    * bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreign body aspiration, bronchopulmonary dysplasia, cystic fibrosis and lower airway mass effects
  * History of congenital heart disease or cardiac arrhythmia or heart failure.
  * Known hypertension
  * Impending respiratory failure (Decreasing mental status, Respiratory fatigue, Impending respiratory arrest, Hypoxemia (pO2 \< 60 mmHg), pCO2 could be normal or high)
  * Allergy or hypersensitivity to epinephrine
  * Patient/Parents refusal to participate in the study

Primary outcomes:
measure: change in pediatric respiratory assessment measure (PRAM) score
timeFrame: at (60) mints
measure: change in pediatric respiratory assessment measure (PRAM) score
timeFrame: at (80) mints
measure: change in pediatric respiratory assessment measure (PRAM) score
timeFrame: at (100) mints
Secondary outcomes:
measure: Emergency Department (ED) length of stay
timeFrame: from the randomization up to 4 hours
measure: The rate for admission
timeFrame: from the randomization up to 4 hours
measure: rate of any side effect of nebulized epinephrine
timeFrame: from the randomization up to 4 hours
measure: The need for respiratory support (O2, Non-invasive ventilation, intubation)
timeFrame: from the randomization to the disposal time
measure: The rate of revisit to Emergency Department within 72 hours of the index visit
timeFrame: Till 72 hours post discharge
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Royal Hospital
Study officials:
References: