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
- 2
- 主要终点
- Frequency 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 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 MAO inhibitors, and use of anti-rejection transplant medications
研究组 & 干预措施
Placebo
Placebo IV + metoclopramide 10mg IV
干预措施: Metoclopramide 10mg (Drug)
Dexamethasone
Dexamethasone 10mg 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 Moderate or Severe headache after Emergency Department (ED) discharge
时间窗: Up to 48 hours after ED discharge
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 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 and their results will not be included in the analysis.
次要结局
- Sustained headache relief(48 hours after ED discharge)
- Post concussive symptoms(7 days after ED discharge)
- Use of Rescue medication(Duration of ED admission, up to 3-4 days)