Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment (IMPACT)

June 4, 2026 updated by: Montefiore Medical Center

A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10467
        • Montefiore Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metoclopramide 10 mg
Metoclopramide 10 mg IV over 15 minutes
Drug: Metoclopramide 10mg
Intravenous drip
Active Comparator: Acetaminophen
1000 Mg IV over 15 minutes
Drug: Acetaminophen
Intravenous drip over 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Time Frame: From 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.
From baseline to 48 hours post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in RPQ score Improvement in post-concussion symptoms measured using the RPQ between baseline and 1 hour after treatment.
Time Frame: From baseline to 1 hour and 7 days post-treatment
Change in post-concussion symptoms will also be measured at 1 hour and 7 days post-treatment using the RPQ as described for the primary outcome. 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.
From baseline to 1 hour and 7 days post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numerical Rating Scale (NRS) pain score
Time Frame: From baseline to 7 days post-treatment
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.
From baseline to 7 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin W Friedman, MD,MS, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

August 4, 2028

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-17404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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