Shortness of Breath, Asthma in Children, Epinephrine Causing Adverse Effects in Therapeutic Use, Salbutamol Adverse Reaction
Conditions
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.
Interventions
we are using 1:1000 epinephrine into nebulization form
DRUGSalbutamol
Patient will receive salbutamol as 4th nebulization.
Sponsors
Oman Medical Speciality Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
the clinical pharmacist will label the medications according to coding system. 2 boxes will be available, one for weight less than 20kg and other box for patient weight more than or equal of 20 kg. Both boxes will contain both medications (epinephrine and salbutamol) in identical syringe with the same volume. The patient, physician and the nurse will be blinded to the 4th nebulization (experimental intervention) Once patient get enrolled in the study and received the standard of care (back to back nebulization), the nurse with take the experimental intervention according to the weight and the coding which been done the pharmacist.
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)
Eligibility
Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in pediatric respiratory assessment measure (PRAM) score | at (60) mints | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department (ED) length of stay | from the randomization up to 4 hours | 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. |
| The rate for admission | from the randomization up to 4 hours | during the assessment this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home. |
| rate of any side effect of nebulized epinephrine | from the randomization up to 4 hours | 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. |
| The need for respiratory support (O2, Non-invasive ventilation, intubation) | from the randomization to the disposal time | during assessment |
| The rate of revisit to Emergency Department within 72 hours of the index visit | Till 72 hours post discharge | after discharge |
Countries
Oman
Outcome results
None listed