Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Already treated with an anti-dopaminergic medication for post-concussion symptoms

Pheochromocytoma

Seizure disorder

Parkinson's disease

Trial design

Treatments tested in this trial

  • Metoclopramide 10mg
  • Acetaminophen

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators