Brief 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.
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.
Brief Title
Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
Detailed Description
Nearly 1.5 million patients present to US emergency departments (ED) annually following head trauma. Many, even with a low velocity mechanism of injury, report a variety of post-concussion symptoms, including headache, dizziness, and nausea. For most patients, post-concussion symptoms will resolve after several days, though up to 1/4 will develop persistent symptomatology that can last months or years.
Very few randomized studies are available to guide treatment of acute post-concussion symptoms. In the absence of evidence, most emergency physicians treat post-concussion symptoms using typical medications for the symptom - thus headache is treated with analgesic medication, nausea with antiemetics, and dizziness with medications such as meclizine. Other symptoms commonly described as part of post-concussion syndrome, such as fatigue, irritability, and poor concentration, are usually left untreated.
Two randomized studies among ED patients who experienced head trauma were recently completed at Montefiore EDs. In the first, one dose of IV metoclopramide, when compared to placebo, improved post-concussion syndrome both in the ED and one week later. In this study, IV metoclopramide was effective against a broad range of symptoms beyond just headache and nausea. Variables related to concentration (including concentration, remembering, and feeling like one is in a fog) were better in the metoclopramide arm at both one hour and at one week. Similarly, variables related to emotion (including feeling more emotional, irritability and sadness) were better in the active group. In the second study, adding IV dexamethasone to metoclopramide did not result in increased or prolonged efficacy.
The pharmacy will use sealedenvelope.com to generate the blinded assignment sequence.
Very few randomized studies are available to guide treatment of acute post-concussion symptoms. In the absence of evidence, most emergency physicians treat post-concussion symptoms using typical medications for the symptom - thus headache is treated with analgesic medication, nausea with antiemetics, and dizziness with medications such as meclizine. Other symptoms commonly described as part of post-concussion syndrome, such as fatigue, irritability, and poor concentration, are usually left untreated.
Two randomized studies among ED patients who experienced head trauma were recently completed at Montefiore EDs. In the first, one dose of IV metoclopramide, when compared to placebo, improved post-concussion syndrome both in the ED and one week later. In this study, IV metoclopramide was effective against a broad range of symptoms beyond just headache and nausea. Variables related to concentration (including concentration, remembering, and feeling like one is in a fog) were better in the metoclopramide arm at both one hour and at one week. Similarly, variables related to emotion (including feeling more emotional, irritability and sadness) were better in the active group. In the second study, adding IV dexamethasone to metoclopramide did not result in increased or prolonged efficacy.
The pharmacy will use sealedenvelope.com to generate the blinded assignment sequence.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
929-731-2137
Central Contact Email
hsarikhani@montefiore.org
Central Contact Role
Contact
Central Contact Phone
718-904-3333
Central Contact Email
befriedman@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
CONCUSSION POST SYNDROME
HEAD TRAUMA INJURY
Eligibility Criteria
Inclusion Criteria:
* 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
* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
* Reported post-concussion symptoms were not present prior to the injury
* Treating attending physician plans to administer a parenteral medication
Exclusion Criteria:
* Already treated with an anti-dopaminergic medication for post-concussion symptoms
* Contraindications to study medications, including:
* Pheochromocytoma
* Seizure disorder
* Parkinson's disease
* Use of monoamine oxidase (MAO) inhibitors
* Use of anti-rejection transplant medications
* Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.
* 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
* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
* Reported post-concussion symptoms were not present prior to the injury
* Treating attending physician plans to administer a parenteral medication
Exclusion Criteria:
* Already treated with an anti-dopaminergic medication for post-concussion symptoms
* Contraindications to study medications, including:
* Pheochromocytoma
* Seizure disorder
* Parkinson's disease
* Use of monoamine oxidase (MAO) inhibitors
* Use of anti-rejection transplant medications
* Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.
Inclusion Criteria
Inclusion Criteria:
* 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
* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
* Reported post-concussion symptoms were not present prior to the injury
* Treating attending physician plans to administer a parenteral medication
* 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
* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10
* Reported post-concussion symptoms were not present prior to the injury
* Treating attending physician plans to administer a parenteral medication
Gender
All
Gender Based
false
Keywords
Concussion
Head Trauma
Acetaminophen
Metoclopramide
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07634393
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-17404
Overall Status
Not yet recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
Primary Outcomes
Outcome Description
Change in post-concussion symptoms from baseline to 48 hours after treatment will be measured using the RPQ. The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury. It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") to 4 ("A severe problem"), for an overall possible range of 0-64, such that higher scores reflect worsening concussive symptomatology. Absolute change from baseline scores will be summarized by study arm using descriptive statistics. For patients requiring rescue therapy in the ED, the pre-rescue medication RPQ score will be used in lieu of the 48-hour score to ensure that the 48-hour outcome reflects the individual's poor response to the investigational medication.
Outcome Measure
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Outcome Time Frame
From baseline to 48 hours post-treatment
Secondary Ids
Secondary Id
2025
Secondary Outcomes
Outcome Description
Change in post-concussion symptoms will also be measured at 1 hour and 7 days post-treatment using the RPQ. The RPQ is a validated instrument designed to quantify the severity of post-concussive symptoms following mild traumatic brain injury. It consists of 16 items encompassing physical (e.g., headache, dizziness), cognitive (e.g., poor concentration, forgetfulness), and emotional (e.g., irritability, depression) domains, each rated on a 5-point Likert scale from 0 ("Not experienced at all") to 4 ("A severe problem"), for an overall possible range of 0-64, such that higher scores reflect worsening concussive symptomatology. For purposes of this study, an absolute change from baseline score will be reported for the 1 hour and 7 days post-treatment timepoints. Values will be summarized by study arm using descriptive statistics.
Outcome Time Frame
From baseline to 1 hour and 7 days post-treatment
Outcome Measure
Change in RPQ score Improvement in post-concussion symptoms measured using the RPQ between baseline and 1 hour after treatment.
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415
Investigator Department
Emergency Medicine
Investigator Sponsor Organization
Montefiore
Study Department
Emergency Medicine
Study Division
Not Applicable
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
MeSH Terms
POST-CONCUSSION SYNDROME
BRAIN CONCUSSION
CRANIOCEREBRAL TRAUMA
HEAD INJURIES, CLOSED
TRAUMA, NERVOUS SYSTEM
NERVOUS SYSTEM DISEASES
WOUNDS AND INJURIES
WOUNDS, NONPENETRATING
BRAIN INJURIES, TRAUMATIC
BRAIN INJURIES
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
METOCLOPRAMIDE
ACETAMINOPHEN
BENZAMIDES
AMIDES
ORGANIC CHEMICALS
PARA-AMINOBENZOATES
AMINOBENZOATES
BENZOATES
ACIDS, CARBOCYCLIC
CARBOXYLIC ACIDS
CHLOROBENZOATES
HYDROXYBENZOATE ETHERS
HYDROXYBENZOATES
HYDROXY ACIDS
BENZENE DERIVATIVES
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
PHENYL ETHERS
PHENOLS
ACETANILIDES
ANILIDES
ANILINE COMPOUNDS
AMINES