Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
研究概览
简要总结
Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation.
Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation.
Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.
In addition to the study intervention, the standardized treatment pathway based on the current asthma guidelines in use at the investigator's center will be utilized. This pathway includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration and dosages of these other interventions will be administered at the discretion of the treating provider.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 6 years and less than 18 years
- •Pre-existing diagnosis of asthma
- •Presenting to the ED with an asthma exacerbation
排除标准
- •History of chronic lung or upper airway disease other than asthma
- •History significant, uncorrected congenital heart disease or cardiac arrhythmia
- •History of thyroid disease
- •Impending respiratory failure
- •Allergy to epinephrine
- •PEFR>60% of predicted and clinical asthma score less than 8
研究组 & 干预措施
No intervention
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
干预措施: No intervention (Other)
结局指标
主要结局
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
时间窗: 15 minutes after the study intervention
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
次要结局
- Disposition(At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention))
- Change in Percent of Predicted PEFR at t120(120 minutes after the study intervention)
- Breaths Per Minute at t120(breaths per minute 120 minutes after the study intervention)
- Heart Rate at t120(up to 120 minutes after the study intervention)
研究者
Kerry Caperell
Assistant Professor of Pediatrics
University of Louisville