Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment

NCT07634393 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025-17404
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Trauma Injury; Concussion Post Syndrome

Keywords

Concussion; Head Trauma; Acetaminophen; Metoclopramide

Outcome Measures

Primary Outcomes (1)

• Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score

  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.

  From baseline to 48 hours post-treatment

Secondary Outcomes (1)

• Change in RPQ score Improvement in post-concussion symptoms measured using the RPQ between baseline and 1 hour after treatment.

  From baseline to 1 hour and 7 days post-treatment

Other Outcomes (1)

• Change in Numerical Rating Scale (NRS) pain score

  From baseline to 7 days post-treatment

Study Arms (2)

Metoclopramide 10 mg

ACTIVE COMPARATOR

Metoclopramide 10 mg IV over 15 minutes

Drug: Metoclopramide 10mg

Acetaminophen

ACTIVE COMPARATOR

1000 Mg IV over 15 minutes

Drug: Acetaminophen

Interventions

Metoclopramide 10mg DRUG

Intravenous drip

Metoclopramide 10 mg

Acetaminophen DRUG

Intravenous drip over 15 minutes

Acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

New York, New York, 10467, United States

Location

Related Publications (9)

• McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.

  PMID: 23479479 BACKGROUND

• Fanciullacci M, Alessandri M, Del Rosso A. Dopamine involvement in the migraine attack. Funct Neurol. 2000;15 Suppl 3:171-81.

  PMID: 11200788 BACKGROUND

• Charbit AR, Akerman S, Goadsby PJ. Dopamine: what's new in migraine? Curr Opin Neurol. 2010 Jun;23(3):275-81. doi: 10.1097/WCO.0b013e3283378d5c.

  PMID: 20164768 BACKGROUND

• Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.

  PMID: 33762421 BACKGROUND

• Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7.

  PMID: 31638888 BACKGROUND

• Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available.

  PMID: 34928511 BACKGROUND

• Evans RW. The Postconcussion Syndrome and Posttraumatic Headaches in Civilians, Soldiers, and Athletes. Neurol Clin. 2024 May;42(2):341-373. doi: 10.1016/j.ncl.2023.12.001. Epub 2024 Jan 16.

  PMID: 38575256 BACKGROUND

• Blyth BJ, Bazarian JJ. Traumatic alterations in consciousness: traumatic brain injury. Emerg Med Clin North Am. 2010 Aug;28(3):571-94. doi: 10.1016/j.emc.2010.03.003.

  PMID: 20709244 BACKGROUND

• Varner C, Thompson C, de Wit K, Borgundvaag B, Houston R, McLeod S. Predictors of persistent concussion symptoms in adults with acute mild traumatic brain injury presenting to the emergency department. CJEM. 2021 May;23(3):365-373. doi: 10.1007/s43678-020-00076-6. Epub 2021 Feb 8.

  PMID: 33555602 BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion; Craniocerebral Trauma

Interventions

Metoclopramide; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Benjamin W Friedman, MD,MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamed Sarikhani, MD

CONTACT

929-731-2137; hsarikhani@montefiore.org

Benjamin W W.Friedman, MD,MS

CONTACT

7189043333; befriedman@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative effectiveness study. Randomization will occur in blocks of four based on a random number generator.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 4, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

US (1)