Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

Starting soon · Phase 4

Conditions studied: Concussion Post Syndrome, Head Trauma Injury

In brief

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.

Key facts

Study ID

NCT07634393

Run by

Montefiore Medical Center

People needed

200

Starts

2026-08-01

Expected to finish

2028-08-04

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Montefiore Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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