Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours
研究概览
简要总结
Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine.
All patients will also be treated with metoclopramide.
详细描述
Investigational medications. Medications in each study arm are as follows:
A. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV B. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 16 mg IV Assignment. Will be concealed. The research pharmacist will determine assignment based on a random number sequence. Randomization. Randomization will occur in blocks of 4 based on a random number generator. Blinding. Patients, clinicians, and research personnel will be blinded. Stratification. Subjects will be stratified by study site (Moses or Weiler) and baseline pain intensity (moderate or severe).
Follow-up phone calls will be performed 48 hours and 7 days after ED (emergency department) discharge. At the first call, the next follow-up phone call will be scheduled. Attempts to complete the follow-up calls successfully will be made every eight hours until deemed futile. At this point, questionnaires will be sent by express courier, and failing this, the investigator will perform a home visit.
At the 48-hour phone call, the focus will be assessments of pain, functional status, migraine associated features, adverse events, satisfaction with the medication received, and use of rescue medication. The focus of the seven day phone call will be on the total number of days with headache since ED discharge, the need for repeat ED visits, healthcare providers visited, days of work missed, and adverse medication effects.
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)
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
- •Moderate or severe migraine
排除标准
- •Medication contra-indication
- •Concern for secondary cause of headache
研究组 & 干预措施
Dexamethasone 4mg
Dexamethasone 4mg, administered intravenously
干预措施: Dexamethasone 4mg (Drug)
Dexamethasone 16mg
Dexamethasone 16mg, administered intravenously
干预措施: Dexamethasone 16mg (Drug)
结局指标
主要结局
Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours
时间窗: 48 hours
The number of subjects achieving sustained headache relief for 48 hours and maintaining this level, without requiring additional rescue therapy for the entire 48 hour follow up period, will be determined. Headache relief will be defined as the number of subjects reporting a headache intensity of either "none" or "mild."
次要结局
- Patient Preference for Receiving the Same Medication for a Subsequent Headache(48 hours)
- Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration(Two hours)
- Additional Headache Medication in the ED(Up to 24 hours)
- Use of Additional Headache Medication After ED Discharge(Up to 24 hours)
- Number of Days With Headache(One week)