Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

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.

Primary Outcome Measures

1. Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
   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.

Secondary Outcome Measures

1. Change in RPQ score Improvement in post-concussion symptoms measured using the RPQ between baseline and 1 hour after 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.