Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

Part of paid clinical trials in New York, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT07634393
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Concussion Post Syndrome
  • Head Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metoclopramide 10mg — DRUG
    Intravenous drip
  • Acetaminophen — DRUG
    Intravenous drip over 15 minutes

Study Details

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 Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Aug 4, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metoclopramide 10 mg
    Metoclopramide 10 mg IV over 15 minutes
  • Active Comparator: Acetaminophen
    1000 Mg IV over 15 minutes

Primary Outcome Measure

Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score [ Time Frame: From baseline to 48 hours post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Montefiore Medical CenterNew YorkNew York10467

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