A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
研究概览
简要总结
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet International Classification of Headache Disorders (3rd edition) criteria for acute post-traumatic headache as follows:
- •Traumatic injury to the head has occurred
- •Headache has developed within 7 days of injury to the head
- •Headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache)
- •The headache must be rated as moderate or severe in intensity at the time of initial evaluation
排除标准
- •More than ten days have elapsed since the head trauma
- •Headache has already been treated with an anti-dopaminergic medication
- •Medication allergies
- •Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of Monoamine oxidase (MAO) inhibitors, and use of anti-rejection transplant medications
研究组 & 干预措施
Dexamethasone
Dexamethasone 10mg IV + metoclopramide 10mg IV
干预措施: Metoclopramide 10mg (Drug)
Placebo
Placebo IV + metoclopramide 10mg IV
干预措施: Metoclopramide 10mg (Drug)
Dexamethasone
Dexamethasone 10mg IV + metoclopramide 10mg IV
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
时间窗: From ED discharge to 48-hours following discharge from the ED, up to 2 days total
Headache intensity will be rated based on the International Headache Society (IHS) 4-point scale. Using this scale participants will verbalize whether their headache intensity is "Severe," "Moderate," "Mild," or "None." The percentage of patients reporting a headache intensity level of either "Moderate" or "Severe" will be grouped and summarized by study arm. The number/percentage of patients reporting a headache intensity level of "Mild" or "None" will also be grouped and summarized by study arm. Between-group difference along with 95% confidence intervals will be reported. Patients who use an analgesic or abortive headache medication during the 48-hour period will be considered an outcome failure.
次要结局
- Sustained Headache Relief(48 hours after administration of study medication)
- Post Concussive Symptoms(48 hours after ED discharge, up to 2 days total)
- Post Concussive Symptoms(7 days after ED discharge, up to 7 days total)
- Use of Rescue Medication in the ED(Duration of ED admission, less than 1 day)