Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary outcome of acute PCH relief will be determined by measuring the difference between VAS score at baseline and after the last dose of study drug.
研究概览
简要总结
Concussion is defined as any temporary disturbance in brain function following a blow to the head. It may not involve a loss of consciousness and usually results in a post concussive headache (PCH) immediately after the injury. Between 30 and 50 percent of patients with concussion will develop postconcussive syndrome (PCS) consisting of symptoms such as headache, and a variety of other debilitating symptoms lasting several weeks to months.
The objective of this study is to determine if metoclopramide, a drug commonly used in the treatment of migraine headache, will be effective in relieving PCH and in preventing PCS.
Eligible patients will have a history of a concussion resulting in headache within the past 24 hours. Patients will rate their pain on a standard scale before and after being treated with one or two intravenous doses of either metoclopramide or saltwater placebo. They will be contacted by telephone 1, 4 and 8 weeks later in order to determine if they have developed the postconcussive syndrome.
详细描述
PURPOSE AND OBJECTIVES The primary objective of this study is to prospectively evaluate the effect of metoclopramide in ED patients with minor head injury. The primary hypothesis is that the administration of intravenous metoclopramide will be effective in relieving the symptoms of acute post traumatic headache in ED patients with minor head injury.
The secondary hypothesis is that the administration of intravenous metoclopramide will also be effective in reducing the incidence of chronic post-concussive syndrome in ED patients with minor head injury. The research question is "Does the administration of intravenous metoclopramide at a dose of 10 or 20 mg to adult ED patients experiencing headache following a minor head injury result in a significant decrease in pain severity as measured on a 10cm visual analogue scale, as compared to placebo?"
RESEARCH METHODOLOGY This is a prospective, double-blind, randomized, placebo-controlled trial.
Only patients who meet the following inclusion criteria will be recruited:
- History of blunt head trauma within preceding 24 hours
- Immediate and transient post traumatic impairment of neurological functions such as alteration of consciousness, amnesia, disorientation, or disturbance of vision or equilibrium.
- Onset of headache within one hour of trauma.
- Significant intra-cranial injury excluded by CT scan or clinical assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients who meet the following inclusion criteria will be recruited:
- •History of blunt head trauma within preceding 24 hours.
- •Immediate and transient post traumatic impairment of neurological functions defined as alteration of consciousness, amnesia, disorientation, disturbance of vision or equilibrium (10).
- •Onset of headache within one hour of trauma.
排除标准
- •Patients with any of the following exclusion criteria will not be enrolled:
- •Age less than or equal to 19 years.
- •Known or suspected pregnancy.
- •Known hypersensitivity or intolerance to metoclopramide.
- •Inability to give informed consent.
- •Known gastrointestinal hemorrhage, perforation or obstruction.
- •Known seizure disorder.
- •Known pheochromocytoma.
- •Concurrent significant CNS depression due to drugs or alcohol.
- •Concurrent treatment for psychiatric illness.
- •Any acute brain injury on CT scan (if performed) as defined by any radiographic finding which would normally require admission to hospital and neurological follow up
结局指标
主要结局
The primary outcome of acute PCH relief will be determined by measuring the difference between VAS score at baseline and after the last dose of study drug.
次要结局
- The secondary outcome of PCS will be measured by telephone questionnaire using the Rivermead Post Concussion Symptoms Questionnaire at 1, 4 and 8 weeks after injury