Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment (NCT07634393) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
United States200 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing intravenous metoclopramide and intravenous acetaminophen for acute concussion — are either of these medications something that might already be an option for me right now through standard care, and how does that compare to joining a trial?
2Since this trial is Phase 4, does that mean both medications already have a stronger safety track record than earlier-phase studies, and what are the known side effects of IV metoclopramide specifically that I should be aware of?
3The trial isn't recruiting yet — given where I am in my recovery right now, is it realistic to wait for this study to open, or would that delay in starting treatment put me at a disadvantage?
4The main thing being measured is change in the Rivermead Post-Concussion Symptoms Questionnaire score — can you explain what that measures and whether it would capture the specific symptoms I'm dealing with most?
5If I don't join this trial, what are the standard treatment options available to me right now for post-concussion symptoms, and how do they compare to what this study is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Timeframe: From baseline to 48 hours post-treatment