About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Already treated with an anti-dopaminergic medication for post-concussion symptoms
Pheochromocytoma
Seizure disorder
Parkinson's disease
Trial design
Parallel
Treatments tested in this trial
Metoclopramide 10mg
DrugIntravenous drip
Acetaminophen
DrugIntravenous drip over 15 minutes
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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.
Other outcomes
Change in Numerical Rating Scale (NRS) pain score
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.
Sponsors and contacts
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