地塞米松治疗创伤后头痛
2026年5月13日 更新者：Montefiore Medical Center
地塞米松辅助治疗急性创伤后头痛的随机研究
这是一项关于静脉注射甲氧氯普胺 + 静脉注射地塞米松与静脉注射甲氧氯普胺治疗急性创伤后头痛患者的随机研究。
研究概览
研究类型
介入性
注册 (实际的)
162
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
The Bronx、New York、美国、10467
- Montefiore
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 包括的患者将是符合国际头痛疾病分类标准的急性创伤后头痛的成年人。 这些如下：
- 头部发生外伤
- 头部受伤后 7 天内出现头痛
- 头痛不能用其他诊断更好地解释（例如，偏头痛或紧张型头痛）
- 在初始评估时，头痛的强度必须被评为中度或重度。
排除标准：
- 如果头部外伤后超过十天，如果头痛已经用抗多巴胺能药物治疗，或药物过敏或禁忌症，包括嗜铬细胞瘤、癫痫发作、帕金森病、使用 MAO，则患者将被排除在外抑制剂，以及使用抗排斥移植药物。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：地塞米松
地塞米松 10 毫克静脉注射 + 甲氧氯普胺 10 毫克静脉注射
|
地塞米松 10 毫克静脉注射
甲氧氯普胺 10mg IV
|
|
安慰剂比较：安慰剂
安慰剂 IV + 甲氧氯普胺 10mg IV
|
甲氧氯普胺 10mg IV
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
大体时间：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.
|
From ED discharge to 48-hours following discharge from the ED, up to 2 days total
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sustained Headache Relief
大体时间：48 hours after administration of study medication
|
Sustained headache pain relief will be defined as the number of patients achieving a headache intensity of "mild" or "none" after administration of study medication and who maintain that level for 48 hours without the use of rescue medication.
The percentage of patients reporting a headache intensity level of either "mild" or "none" will be considered to have achieved and maintained sustained headache relief and will be summarized by study arm.
|
48 hours after administration of study medication
|
|
Post Concussive Symptoms
大体时间：48 hours after ED discharge, up to 2 days total
|
Post concussive symptoms at 48 hours will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS).
Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132.
Higher SCAT PCSS scores are indicative greater severity of post-concussive symptoms.
Results will be summarized by study arm using basic descriptive statistics.
|
48 hours after ED discharge, up to 2 days total
|
|
Post Concussive Symptoms
大体时间：7 days after ED discharge, up to 7 days total
|
Post concussive symptoms at 7 days will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS).
Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132.
Higher SCAT PCSS scores are indicative of greater severity of post-concussive symptoms.
Results will be summarized by study arm using basic descriptive statistics.
|
7 days after ED discharge, up to 7 days total
|
|
Use of Rescue Medication in the ED
大体时间：Duration of ED admission, less than 1 day
|
Use of rescue medication will be defined as the number of patients administered any analgesic medication or headache abortive medication while in the ED.
The number of patients who used rescue medication while in the ED will be summarized by study arm.
|
Duration of ED admission, less than 1 day
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Days With Headache During the Week After ED Discharge
大体时间：Up to 1 week after ED discharge, up to 7 days total
|
The mean number of days with headache during the 1-week period following discharge will be summarized by study arm using basic descriptive statistics
|
Up to 1 week after ED discharge, up to 7 days total
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Benjamin Friedman, MD、Montefiore Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Blyth BJ, Bazarian JJ. Traumatic alterations in consciousness: traumatic brain injury. Emerg Med Clin North Am. 2010 Aug;28(3):571-94. doi: 10.1016/j.emc.2010.03.003.
- Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb.
- Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7.
- Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.
- Orr SL, Friedman BW, Christie S, Minen MT, Bamford C, Kelley NE, Tepper D. Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies. Headache. 2016 Jun;56(6):911-40. doi: 10.1111/head.12835.
- Evans RW. The Postconcussion Syndrome and Posttraumatic Headaches in Civilians, Soldiers, and Athletes. Neurol Clin. 2024 May;42(2):341-373. doi: 10.1016/j.ncl.2023.12.001. Epub 2024 Jan 16.
- Shah R, Das S, Gentile Kruse CF, de Prado BM, Raj N, Evans M, Panigrahi P, Hershey AD, Master CL, Szperka CL, Patterson Gentile C. Patterns of Use and Benefit of Triptans in the Treatment of Acute Headache Worsening in Youth With Post-Traumatic Headache. Pediatr Neurol. 2025 Jun;167:96-102. doi: 10.1016/j.pediatrneurol.2025.03.013. Epub 2025 Mar 27.
- Patterson Gentile C, Shah R, Irwin SL, Greene K, Szperka CL. Acute and chronic management of posttraumatic headache in children: A systematic review. Headache. 2021 Nov;61(10):1475-1492. doi: 10.1111/head.14236. Epub 2021 Dec 4.
- Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.
- Navratilova E, Rau J, Oyarzo J, Tien J, Mackenzie K, Stratton J, Remeniuk B, Schwedt T, Anderson T, Dodick D, Porreca F. CGRP-dependent and independent mechanisms of acute and persistent post-traumatic headache following mild traumatic brain injury in mice. Cephalalgia. 2019 Dec;39(14):1762-1775. doi: 10.1177/0333102419877662. Epub 2019 Sep 24.
- Kamins J. Models for Treating Post-traumatic Headache. Curr Pain Headache Rep. 2021 Jun 14;25(8):52. doi: 10.1007/s11916-021-00970-3.
- Zeng Z, Wei L, Zhang H, Chen W, Wang S. The Effect of Dexamethasone on Neuroinflammation and Cerebral Edema in Rats With Traumatic Brain Injury Combined With Seawater Drowning. Cureus. 2024 Mar 1;16(3):e55309. doi: 10.7759/cureus.55309. eCollection 2024 Mar.
- Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available.
- May A, Evers S, Goadsby PJ, Leone M, Manzoni GC, Pascual J, Carvalho V, Romoli M, Aleksovska K, Pozo-Rosich P, Jensen RH; European Academy of Neurology Task Force. European Academy of Neurology guidelines on the treatment of cluster headache. Eur J Neurol. 2023 Oct;30(10):2955-2979. doi: 10.1111/ene.15956. Epub 2023 Jul 28.
- Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.
- Friedman BW, Solorzano C, Kessler BD, Martorello K, Lutz CL, Feliciano C, Adler N, Moss H, Cain D, Irizarry E. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine. Neurology. 2023 Oct 3;101(14):e1448-e1454. doi: 10.1212/WNL.0000000000207648. Epub 2023 Aug 21.
- Ashina H, Diener HC, Tassorelli C, Scher AI, Lipton RB, Pozo-Rosich P, Sinclair AJ, Chong CD, Finkel AG, Ashina M, Schwedt TJ, Dodick DW, Terwindt GM. Guidelines of the International Headache Society for controlled trials of pharmacological preventive treatment for persistent post-traumatic headache attributed to mild traumatic brain injury. Cephalalgia. 2024 Mar;44(3):3331024241234068. doi: 10.1177/03331024241234068.
- Chin EY, Nelson LD, Barr WB, McCrory P, McCrea MA. Reliability and Validity of the Sport Concussion Assessment Tool-3 (SCAT3) in High School and Collegiate Athletes. Am J Sports Med. 2016 Sep;44(9):2276-85. doi: 10.1177/0363546516648141. Epub 2016 Jun 8.
- Friedman BW, Babbush K, Irizarry E, White D, John Gallagher E. An exploratory study of IV metoclopramide+diphenhydramine for acute post-traumatic headache. Am J Emerg Med. 2018 Feb;36(2):285-289. doi: 10.1016/j.ajem.2017.10.034. Epub 2017 Oct 13.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年6月25日
初级完成 (实际的)
2024年11月17日
研究完成 (实际的)
2024年12月22日
研究注册日期
首次提交
2021年3月11日
首先提交符合 QC 标准的
2021年3月11日
首次发布 (实际的)
2021年3月16日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2020-12625
- UL1TR001073 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The de-identified dataset will be made available to clinical researchers upon approval of the analytic plan.
Requests should be made to the corresponding author.
IPD 共享时间框架
Upon approval of the analytic plan.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.