Intravenous Fluids in Benign Headaches Trial: A Randomized Single Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Reduction in Pain Scores at 60 Minutes
研究概览
简要总结
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.
详细描述
This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a "rescue medication" of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.
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
- Single (Participant)
盲法说明
By necessity the subject will be blinded but the RN administering the IV fluids will need to know the rate of infusion.
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 to 65 years
- •Temperature less than 100.4 F
- •Normal neurologic exam and normal mental status
排除标准
- •Meningeal signs are present
- •Acute angle closure glaucoma is suspected
- •Head trauma within the previous two weeks
- •Lumbar puncture within the previous two weeks
- •Thunderclap onset of the headache
- •Known allergy to one of the study drugs
- •History of intracranial hypertension
- •Is a prisoner
- •Patient declined informed consent
- •Non-English speaking patient or parent/guardian for pediatric patients
- •Attending provider excludes patient
- •Severe Dehydration
研究组 & 干预措施
Standard Treatment Arm
Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
干预措施: Normal Saline 5mL (Drug)
Standard Treatment Arm
Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
干预措施: Prochlorperazine 0.15 mg/kg up to 10 mg IV (Drug)
Standard Treatment Arm
Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
干预措施: Diphenhydramine 1 mg/kg up to 50 mg IV (Drug)
Study Arm
Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
干预措施: Normal Saline 20mL/kg (Drug)
Study Arm
Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
干预措施: Prochlorperazine 0.15 mg/kg up to 10 mg IV (Drug)
Study Arm
Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
干预措施: Diphenhydramine 1 mg/kg up to 50 mg IV (Drug)
结局指标
主要结局
Reduction in Pain Scores at 60 Minutes
时间窗: 60 minutes
The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.
次要结局
- Reduction in Pain Score at 30 Minutes(30 minutes)
- Admissions(1 day)
- Reduction in Nausea Score at 60 Minutes(60 minutes)
- Vomiting(60 minutes)
- Rescue Medication(60 minutes)
- Percentage of Patients With Persistent Headache(24-48 hours after discharge.)
研究者
Joseph (Tony) Zitek, MD
MD
University Medical Center of Southern Nevada