Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment (IMPACT)
A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
The IMPACT study is a randomized, double-blind clinical trial evaluating two commonly used intravenous medications - metoclopramide and acetaminophen - for treating acute post-concussion symptoms in emergency department patients after mild head injury. The study aims to determine which treatment more effectively improves symptoms such as headache, dizziness, nausea, concentration difficulties, and emotional changes within the first week after injury.
Participants will be enrolled across two Montefiore emergency departments and followed using a validated post-concussion symptom questionnaire. Findings from this study may help improve evidence-based treatment strategies for patients experiencing concussion-related symptoms after head trauma.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Nearly 1.5 million patients present to US emergency departments (ED) annually following head trauma. Many, even with a low velocity mechanism of injury, report a variety of post-concussion symptoms, including headache, dizziness, and nausea. For most patients, post-concussion symptoms will resolve after several days, though up to 1/4 will develop persistent symptomatology that can last months or years.
Very few randomized studies are available to guide treatment of acute post-concussion symptoms. In the absence of evidence, most emergency physicians treat post-concussion symptoms using typical medications for the symptom - thus headache is treated with analgesic medication, nausea with antiemetics, and dizziness with medications such as meclizine. Other symptoms commonly described as part of post-concussion syndrome, such as fatigue, irritability, and poor concentration, are usually left untreated.
Two randomized studies among ED patients who experienced head trauma were recently completed at Montefiore EDs. In the first, one dose of IV metoclopramide, when compared to placebo, improved post-concussion syndrome both in the ED and one week later. In this study, IV metoclopramide was effective against a broad range of symptoms beyond just headache and nausea. Variables related to concentration (including concentration, remembering, and feeling like one is in a fog) were better in the metoclopramide arm at both one hour and at one week. Similarly, variables related to emotion (including feeling more emotional, irritability and sadness) were better in the active group. In the second study, adding IV dexamethasone to metoclopramide did not result in increased or prolonged efficacy.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Hamed Sarikhani, MD
- Номер телефона: 929-731-2137
- Электронная почта: hsarikhani@montefiore.org
Учебное резервное копирование контактов
- Имя: Benjamin W W.Friedman, MD,MS
- Номер телефона: 7189043333
- Электронная почта: befriedman@montefiore.org
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10467
- Montefiore Medical Center
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Контакт:
- Hamed Sarikhani Assistant Professor of Emergency Medicine, MD
- Номер телефона: 929-731-2137
- Электронная почта: hsarikhani@montefiore.org
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Контакт:
- Benjamin W.Friedman, MD,MS
- Номер телефона: 718-904-3333
- Электронная почта: befriedman@montefiore.org
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adults presenting to one of the study emergency departments (EDs)
- Acute minor traumatic brain injury/concussion as defined by the Zurich Consensus Statement, including symptoms in somatic, cognitive, emotional, behavioral, physical, cognitive impairment, or sleep domains
- ED visit occurring within 7 days of the head injury
- Overall pain intensity greater than >=6 on a 0-10 scale
- Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
- Reported post-concussion symptoms were not present prior to the injury
- Treating attending physician plans to administer a parenteral medication
Exclusion Criteria:
- Already treated with an anti-dopaminergic medication for post-concussion symptoms
- Contraindications to study medications, including:
- Pheochromocytoma
- Seizure disorder
- Parkinson's disease
- Use of monoamine oxidase (MAO) inhibitors
- Use of anti-rejection transplant medications
- Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Metoclopramide 10 mg
Metoclopramide 10 mg IV over 15 minutes
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Intravenous drip
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Активный компаратор: Acetaminophen
1000 Mg IV over 15 minutes
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Intravenous drip over 15 minutes
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Временное ограничение: From baseline to 48 hours post-treatment
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Change in post-concussion symptoms from baseline to 48 hours after treatment will be measured using the RPQ.
The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury.
It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") to 4 ("A severe problem"), for an overall possible range of 0-64, such that higher scores reflect worsening concussive symptomatology.
Absolute change from baseline scores will be summarized by study arm using descriptive statistics.
For patients requiring rescue therapy in the ED, the pre-rescue medication RPQ score will be used in lieu of the 48-hour score to ensure that the 48-hour outcome reflects the individual's poor response to the investigational medication.
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From baseline to 48 hours post-treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in RPQ score Improvement in post-concussion symptoms measured using the RPQ between baseline and 1 hour after treatment.
Временное ограничение: From baseline to 1 hour and 7 days post-treatment
|
Change in post-concussion symptoms will also be measured at 1 hour and 7 days post-treatment using the RPQ.
The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury.
It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") to 4 ("A severe problem"), for an overall possible range of 0-64, such that higher scores reflect worsening concussive symptomatology.
For purposes of this study, an absolute change from baseline score will be reported for the 1 hour and 7 days post-treatment timepoints.
Values will be summarized by study arm using descriptive statistics.
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From baseline to 1 hour and 7 days post-treatment
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Numerical Rating Scale (NRS) pain score
Временное ограничение: From baseline to 7 days post-treatment
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Change in pain score from baseline to 7 days post-treatment will be assessed using the NRS for pain.
The NRS is a commonly used rating scale for pain in ED studies and is comprised of a segmented, 11-point assessment wherein patients verbally identify their pain severity on a scale ranging from 0 ("No pain") to 10 ("Worst pain imaginable"), such that higher scores are indicative of increased pain intensity.
For purposes of this outcome, a relative change from baseline score will be reported for the 7-day post-treatment timepoint.
Values will be summarized by study arm using descriptive statistics.
Changes in pain scores will be analyzed in relation to RPQ symptom improvement as an exploratory outcome.
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From baseline to 7 days post-treatment
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Benjamin W Friedman, MD,MS, Montefiore Medical Center
Публикации и полезные ссылки
Общие публикации
- 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.
- 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.
- McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.
- 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.
- 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.
- Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available.
- Fanciullacci M, Alessandri M, Del Rosso A. Dopamine involvement in the migraine attack. Funct Neurol. 2000;15 Suppl 3:171-81.
- Charbit AR, Akerman S, Goadsby PJ. Dopamine: what's new in migraine? Curr Opin Neurol. 2010 Jun;23(3):275-81. doi: 10.1097/WCO.0b013e3283378d5c.
- Varner C, Thompson C, de Wit K, Borgundvaag B, Houston R, McLeod S. Predictors of persistent concussion symptoms in adults with acute mild traumatic brain injury presenting to the emergency department. CJEM. 2021 May;23(3):365-373. doi: 10.1007/s43678-020-00076-6. Epub 2021 Feb 8.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Повреждения головного мозга, травматические
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Раны и травмы
- Травма, нервная система
- Травмы головы, закрытые
- Раны, Непроникающие
- Травмы головного мозга
- Сотрясение мозга
- Постконтузионный синдром
- Черепно-мозговая травма
- Органические химические вещества
- Углеводороды
- Углеводороды, циклические
- Карбоновые кислоты
- Гидрокси кислоты
- Углеводороды, ароматные
- Анилиды
- Амиды
- Анилиновые соединения
- Амины
- Ацетанилиды
- Фенолы
- Бензольные производные
- Кислоты, карбоциклический
- Пара-аминобензоаты
- Аминобензоаты
- Бензоаты
- Гидроксибензоаты
- Фенил -эфиры
- Бензамиды
- Хлорбензоаты
- Гидроксибензоат -эфиры
- Ацетаминофен
- Метоклопрамид
Другие идентификационные номера исследования
- 2025-17404
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .