Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Recurrence of headache
研究概览
简要总结
For some patients who come to the emergency department for treatment of a migraine headache, peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective treatment for headache relief. Previous studies have demonstrated that adding steroids as an adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the subsequent few days.
详细描述
Previous studies have provided evidence that administering steroids in addition to standard migraine headache treatment in the emergency department may reduce the recurrence of the headache within 24-72 hours. The standard migraine treatments in previous studies have been varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS, and opioid analgesics. The steroids added to the standard treatment have been prednisone and dexamethasone (both IV and oral).
This is the first study to examine the combination of peripheral nerve block as the primary treatment of migraine followed by oral dexamethasone to prevent recurrence.
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
study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet ICHD-3 Migraine Headache Criteria
- •Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2
- •Nerve block performed with bupivacaine 0.5%
排除标准
- •Head trauma
- •Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)
- •Headache in the setting of viral syndrome
- •Chronically on steroids
- •Known allergy to dexamethasone
- •Unable to reach the patient by phone or text for follow-up
- •Gestational diabetes or other uncontrolled diabetes
- •Known to be immunocompromised
研究组 & 干预措施
Placebo
Single oral dose of placebo pill
干预措施: Placebo (Drug)
Dexamethasone
single oral dose of dexamethasone (8mg)
干预措施: Dexamethasone Oral (Drug)
结局指标
主要结局
Recurrence of headache
时间窗: 72-96 hours post treatment
Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred
次要结局
- Early recurrence headache and timing(72-96hrs post treatment)
- side effects of dexamethasone identified if any(72-96 hrs post treatment)
研究者
Edward Michelson, MD
Professor and Chair Dept of Emergency Medicine
Texas Tech University Health Sciences Center, El Paso