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NCT07634393

Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
Montefiore Medical Center
~200 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Metoclopramide 10mgAcetaminophen

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Measured over From baseline to 48 hours post-treatment

Conditions

Concussion Post Syndrome
Head Trauma Injury

Explore related trials

ConcussionTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Benjamin W Friedman, MD,MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Hamed Sarikhani, MD
[email protected]
929-731-2137
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) scoreFrom baseline to 48 hours post-treatment

    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.