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Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

NCT07634393 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Concussion Post Syndrome
  • Head Trauma Injury

Interventions

DRUG

Metoclopramide 10mg

Intravenous drip

DRUG

Acetaminophen

Intravenous drip over 15 minutes

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-06-30
Completion
2028-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634393 on ClinicalTrials.gov