Treatment of Acute Migraine Headache in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.
研究概览
简要总结
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of acute migraine headache. The primary outcome will be the number of subjects headache free at two hours.
详细描述
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation of children [1-3]. Despite the high prevalence, there have been few pediatric studies of the acute treatment of migraine headache. Anti-dopaminergic medications such as metoclopramide are often considered first line medications in the emergency room treatment of acute migraine [personal communication with Children's Hospital of Philadelphia Emergency Department physicians], but only two pediatric studies guide this clinical management. One was a retrospective, uncontrolled, descriptive study [4] and one was a prospective, double-blind study that compared an anti-dopaminergic medication to a different medication but did not include a control group [5]. More rigorous studies are needed to determine whether commonly utilized anti-dopaminergic medications are efficacious.
We will perform a prospective, randomized, double-blind placebo controlled study of the acute treatment of pediatric migrainous headache with metoclopramide.
Primary Objective The primary objective of the study is to determine whether metoclopramide added to standard care [intravenous (iv) hydration, darkened room] is superior to placebo and standard care in resolving acute migraine headache intensity within two hours in children aged 8 to 18 years presenting to the emergency department (ED).
Secondary Objectives:
- Determine whether metoclopramide added to standard care (iv hydration, darkened room) is superior to placebo and standard care in resolving acute migraine headache intensity within one hour in children aged 8 to 18 years presenting to the emergency department.
- Determine whether metoclopramide added to standard care (iv hydration, darkened room) is superior to placebo and standard care in resolving acute migraine headache intensity at 24 hours in children aged 8 to 18 years presenting to the emergency department.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females age 8-18 years
- •Girls 11 years or older must have a negative urine/serum pregnancy test.
- •Diagnosis of pediatric migrainous headache. The criteria for pediatric migraine headache based on the most recent ICHD criteria are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred.
排除标准
- •Evidence that headache is due to a secondary underlying disorder based on history or physical examination.
- •Pregnant or lactating females.
- •Any investigational drug use within 30 days.
- •Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease.
- •Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation.
- •Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity.
- •If patients re-present to the ED, they can not be re-enrolled.
研究组 & 干预措施
Placebo
Standard care including intravenous fluid, but no metoclopramide.
干预措施: Placebo (Other)
Metoclopramide
Standard care including intravenous fluid PLUS metoclopramide.
干预措施: Metoclopramide (Drug)
结局指标
主要结局
The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.
时间窗: 2 hours
The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.
次要结局
- The Number of Subjects With a NRS Score of Zero at One Hour.(1 hour)
- Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.(1 hours)
- The Number of Subjects With a NRS Score of Zero at 24 Hours.(24 hours)
- Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.(2 hours)
- Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.(24 hours)