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 — DRUGIntravenous drip
- Acetaminophen — DRUGIntravenous 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 mgMetoclopramide 10 mg IV over 15 minutes
- Active Comparator: Acetaminophen1000 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
- Hamed Sarikhani, MD929-731-2137
- Benjamin W W.Friedman, MD,MS7189043333
Locations (1)
| Facility | City | State | ZIP |
|---|---|---|---|
| Montefiore Medical Center | New York | New York | 10467 |
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