Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department
研究概览
简要总结
BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous oxide has analgesic properties similar to those of opioids and is easy to administer. It has been shown in two small studies to be effective in treating migraine headaches.
RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of acute migraine headaches in children and adolescents presenting to an Emergency Department?
DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be taken to examine change in pain scores before and after nitrous oxide treatment.
METHODS Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment at multiple time-points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •During the study enrollment period, eligible subjects will be English-speaking children and adolescents
- •Between the ages of 8 - 18 years (inclusive)
- •With history of migraine present for at least one year
- •With previous migraine headaches conforming to ICHD-II diagnostic criteria
- •Able to give assent according to institutional guidelines, and
- •Have parental consent to participate.
排除标准
- •Any patients will be excluded if he/she
- •Has had any neurosurgical interventions
- •Has underlying seizure disorders
- •Presents with a headache of a different quality than their other migraines
- •Has contraindications to nitrous oxide
- •Unable to complete the pain assessment
- •Does not have a dependable contact number for the follow-up call
研究组 & 干预措施
Nitrous Oxide
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department
时间窗: within 48 hours
次要结局
未报告次要终点