The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in pediatric respiratory assessment measure (PRAM) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric age group 3 - 12 years
- •known to have asthma
- •Initial PRAM Score showed moderate to severe asthma exacerbation
排除标准
- •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
研究组 & 干预措施
epinephrine group
this arm will include the participant who will receive back to back nebulization (standard of care) plus epinephrine nebulization.
干预措施: nebulized epinephrine (Drug)
control group
in this arm, participant will receive the standard of care treatment (salbutamol and ipratropium, back to back) plus salbutamol as 4th nebulization.
干预措施: Salbutamol (Drug)
结局指标
主要结局
change in pediatric respiratory assessment measure (PRAM) score
时间窗: at (100) mints
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.
次要结局
- rate of any side effect of nebulized epinephrine(from the randomization up to 4 hours)
- The rate of revisit to Emergency Department within 72 hours of the index visit(Till 72 hours post discharge)
- The need for respiratory support (O2, Non-invasive ventilation, intubation)(from the randomization to the disposal time)
- Emergency Department (ED) length of stay(from the randomization up to 4 hours)
- The rate for admission(from the randomization up to 4 hours)
研究者
Adnan Juma Al Rawahi
Emergency Medicine Resident
Oman Medical Speciality Board