Does a Single Oral Dose of Dexamethasone After Successful Emergency Treatment of Migraine Reduce the Incidence or Severity of Rebound Headache Within 48 Hours?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
研究概览
简要总结
The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the emergency department (ED) [after successful treatment] prevents rebound headache.
Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.
详细描述
Migraine headache can be a debilitating condition. A small but significant proportion of sufferers seek treatment in emergency departments [ED], accounting for 2-5% of ED visits.Available data suggests that up to 66% of these patients may experience rebound headache after discharge that affects their ability to function normally [eg work, social, etc].It appears that inflammation plays a key role in recurrences. A number of small studies suggest that a single dose of corticosteroids at the time of discharge might prevent rebound headache. To date these studies have used intravenous dexamethasone. The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the ED [after successful treatment] prevents rebound headache.
Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.
Aims: The primary aim is to compare the proportion of patients who experience rebound headache within 48 hours after ED treatment of migraine between a group treated with single dose oral dexamethasone 8mg and a group treated with placebo. Secondary aims are to compare headache severity, analgesia/ health service use, adverse events and return to normal functioning between the groups.
Methods:
Study design: Double blind, randomised placebo controlled clinical trial. Setting: Emergency Department, Western Hospital. Participants: Adult patients [age >17 years] with physician-diagnosed migraine treated in the ED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up
排除标准
- •Failure to consent
- •Pregnancy
- •Allergy to study medication
- •Findings inconsistent with migraine
- •Patients requiring hospital admission for further investigation and treatment
- •Patients with active peptic ulcer disease
- •Patients with Type 1 diabetes
- •Patients taking corticosteroids for another condition within 7 days
- •Active systemic fungal infection
- •Patients previously enrolled in the study
研究组 & 干预措施
1
This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
干预措施: placebo (Drug)
2
This group received intravenous phenothiazine migraine treatment (dosage at physician discretion) plus oral dexamethasone 8mg at time of emergency department discharge. Patients and clinicians were blinded.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
时间窗: 48 hours
Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
Proportion of Patients With Recurrent Headache Within 48 Hours.
时间窗: 48 hours
Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
次要结局
- Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.(48 hours)
研究者
Professor Anne-Maree Kelly
Director JECEMR
The Joseph Epstein Centre for Emergency Medicine Research