Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to headache resolution
研究概览
简要总结
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.
详细描述
This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Excluded populations include those with sickle cell, concern for CNS infection
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pharmacy sends down drug and placebo in study preparations for administration.
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frontal migraine headache
排除标准
- •Non-english speaking
- •Known pregnancy
- •Sickle cell hemaglobinopathy
- •Concern for CNS infection
- •Acute febrile illness
- •non-frontal headaches
- •Concern for increased intracranial pressure
研究组 & 干预措施
SPG block
SPG block performed by using qtip applicator soaked in 2% lidocaine and placed posteriorly into nasal cavity where it dwells for up to 30 min
干预措施: Lidocaine topical (Drug)
Control
Delivered through IV access obtained in all patients.
干预措施: Prochlorperazine Injection (Drug)
结局指标
主要结局
Time to headache resolution
时间窗: treatment start to patient reported resolution, up to 6 hours
Time to headache resolution in emergency department
ED Length of stay
时间窗: Registration to discharge up to 6 hours
treatment to discharge
次要结局
- 24 hr follow up(1 day)
- Number of participants with treatment induced side effects(1 day)
- Patient satisfaction: Rated on a Likert 100 millimeter scale(Within 6 hours from ED registration)
- Determine adequacy of blinding(Asked at time of patient discharge from the emergency department or at 1 hr.)
研究者
Adam B Sivitz, MD
Medical Director Pediatric Emergency Medicine
Newark Beth Israel Medical Center