Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Verbal Pain Score at 60 Minutes
研究概览
简要总结
The purpose of this study is to determine whether patients in the emergency department with migraine headache who are administered an intravenous fluid bolus will report greater improvement in pain scores than control patients.
详细描述
The investigators intend to perform a small-scale pilot study assessing the effectiveness of IV fluid therapy for patients presenting to the ED with migraine headache. Patients will be randomly allocated to receive a bolus of 1000 ml normal saline or no fluid bolus. Patients and outcome assessors will be blinded to the assigned study group. Research assistants will assess pain scores, nausea, and functional disability at time 0 (just prior to starting the intervention), 60 minutes, and 120 minutes. Participants will be contacted 48 hours after leaving the ED to assess symptom burden following discharge.
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
- Triple (Participant, 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
- •Age 18 or older
- •Fluent in English
- •Meets International Classification of Headache Disorders (3rd ed) criteria for migraine headache:
- •A. At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- •C. Headache has at least two of the following four characteristics:
- •unilateral location pulsating quality moderate or severe pain intensity aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
- •D. During headache at least one of the following:
- •nausea and/or vomiting
- •photophobia and phonophobia E. Not better accounted for by another ICHD-3 diagnosis.
排除标准
- •Intravenous Fluids are contraindicated in the opinion of the emergency department physician caring for the patient (ex patient has an exacerbation of congestive heart failure).
- •Intravenous fluids are required in the opinion of the emergency department physician caring for the patient (ex patient has intractable vomiting, patient has severe dehydration).
- •Have already received greater than or equal to 500 ml of intravenous fluid during this emergency department visit, prior to enrollment.
- •Currently pregnant
研究组 & 干预措施
IV fluid bolus
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
干预措施: Normal saline (1000 mL) (Other)
Control
Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.
干预措施: Control (Other)
结局指标
主要结局
Verbal Pain Score at 60 Minutes
时间窗: 60 minutes
The primary outcome will be the difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and one hour later, at completion of the intervention. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.
次要结局
- Percentage of Patients Free of Pain at 2 Hours(120 minutes)
- Verbal Pain Score at 120 Minutes(120 minutes)
- Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes(60 minutes)
- Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit(48 hours)
- Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes(60 mins)
- Percentage of Patients Who Needed Rescue Medications(120 minutes)
- Length of Stay(1 day)
- Verbal Pain Score at 48 Hours(48 hours)
研究者
Christopher Jones
Assistant Professor
The Cooper Health System