Metoclopramide vs Acetaminophen for Concussion

(IMPACT Trial)

HS
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Overseen ByBenjamin W Friedman, MD,MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two common medications, metoclopramide (used for nausea) and acetaminophen (a pain reliever), to determine which better eases symptoms after a mild head injury, such as headaches, dizziness, or trouble concentrating. It targets individuals who recently experienced a concussion and are suffering from pain or other symptoms as a result. Participants should have sustained their concussion within the last week and be experiencing significant pain or post-concussion symptoms not present before the injury. The trial aims to improve concussion treatment in the emergency department by identifying the more effective medication. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they can benefit more patients.

What is the safety track record for these treatments?

Research has shown that both metoclopramide and acetaminophen are generally well-tolerated. Studies have found that metoclopramide, often used in emergencies, is safe for short-term use and can help manage symptoms like nausea and headaches after a concussion.

Acetaminophen is widely recognized as a safe and effective treatment for headaches, including those from concussions. It is often recommended for relieving post-concussion symptoms such as pain and discomfort.

No major side effects have been commonly reported for either medication in these situations. However, some individuals might experience side effects like drowsiness or mild stomach issues. Participants should discuss any concerns with their healthcare provider before joining a trial.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using metoclopramide and acetaminophen for treating concussions because they offer new ways to manage symptoms. Metoclopramide is typically used for nausea and migraines, and it might help with concussion symptoms by improving blood flow in the brain and reducing headache-related nausea. Acetaminophen is a pain reliever, and while it's commonly used, administering it intravenously can provide faster relief for concussion-related headaches compared to oral options. These treatments are being explored for their potential to provide quicker and more effective symptom relief than standard pain medications like NSAIDs.

What evidence suggests that this trial's treatments could be effective for post-concussion symptoms?

This trial will compare Metoclopramide and Acetaminophen for treating concussion symptoms. Studies have shown that Metoclopramide can reduce headache pain in individuals with post-head injury headaches. Specifically, one study found that patients who took Metoclopramide experienced significant improvement compared to those who took a placebo, which contains no active medicine. Acetaminophen, a common pain reliever, can also aid in faster recovery from concussions. Research suggests that over-the-counter pain relievers like Acetaminophen help individuals resume normal activities sooner after a concussion. Both treatments have evidence supporting their effectiveness in managing post-concussion symptoms.678910

Who Is on the Research Team?

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Benjamin W Friedman, MD,MS

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who come to the emergency room within 7 days of a mild head injury and are experiencing new, significant post-concussion symptoms like headache or dizziness. They must have moderate-to-severe pain and their doctor plans to give them medication through an IV.

Inclusion Criteria

Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
I went to the emergency room within 7 days of my head injury.
My pain level is 6 or higher on a scale from 0 to 10.
See 4 more

Exclusion Criteria

I do not have any conditions that prevent me from taking the study medications.
I do not have any reasons that prevent me from taking the study medications.
I cannot take the study drugs or MAO inhibitors.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intravenous metoclopramide or acetaminophen for acute post-concussion symptoms

Immediate (single dose)
1 visit (in-person)

Follow-up

Participants are monitored for changes in post-concussion symptoms using the RPQ and NRS pain score

7 days
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Metoclopramide

Trial Overview

The study compares two IV medications—metoclopramide (10mg) versus acetaminophen—to see which works better at relieving acute concussion symptoms such as headache, nausea, and trouble concentrating in the first week after injury. Participants are randomly assigned to one treatment group.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Metoclopramide 10 mgActive Control1 Intervention
Group II: AcetaminophenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Citations

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It also highlighted that providing clinical guidance to health care providers is critical to improving the health and safety of this vulnerable population.

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