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Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury (IVAMTBI)

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ClinicalTrials.gov Identifier: NCT02443142
Recruitment Status : Unknown
Verified March 2015 by Demetrios Kyriacou, Northwestern University.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Collaborator:
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Demetrios Kyriacou, Northwestern University

Brief Summary:
Traumatic brain injury (TBI) is an important public health problem with an estimated 1.7 million new cases in the United States each year. Although the vast majority of these victims sustain mild TBI, many still develop headache, difficulty concentrating, and decreased memory with potential for serious long-term consequences. In particular, mild TBI is an important consequence of combat-related injuries sustained by military personnel and sports-related injuries in young adults. Unfortunately, treatment of mild TBI is usually limited to oral analgesics for headache pain such as acetaminophen (Tylenol) or ibuprofen (Motrin or Advil). Since there are no previous randomized trials of these medications for mild TBI, their comparative effectiveness is not known. Increasing animal based evidence suggests that mild TBI is related to brain cell injury caused by overexpression of a cellular enzyme (COX-2) that causes neuroinflammation. Fortunately, inhibition of COX-2 is easily achieved using ibuprofen. We hypothesize that head injured patients treated with ibuprofen will have a lower incidence of mild TBI symptoms than patients treated with acetaminophen. We will conduct a randomized clinical trial to measure the comparative effects of ibuprofen versus acetaminophen on the incidence of specific symptoms of mild TBI in emergency department patients with head injury.

Condition or disease Intervention/treatment Phase
Brain Concussion Drug: Ibuprofen Drug: Acetaminophen Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury
Study Start Date : May 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibuprofen
Ibuprofen is a nonselective NSAID that inhibits both COX-1 and COX-2 isoenzymes. COX-2 inhibition prevents arachidonic acid from converting to vasoactive prostaglandins and reactive oxygen species in brain cell. The analgesic, antipyretic, and antiinflammatory activity of ibuprofen operates mainly through inhibition of COX-2. The experimental treatment oral doses of either ibuprofen (800 mg three times per day). Subjects will receive the first medication dose in the emergency department and will be given the remaining 5 doses to take over 48 hours as outpatients.
Drug: Ibuprofen
Ibuprofen 800 mg orally three times per day for two days for study subjects who are randomized to the ibuprofen arm.
Other Name: motrin

Active Comparator: Acetaminophen
Acetaminophen is a poor inhibitor of both COX isoenzymes in the CNS and has significantly weaker antiinflammatory effects than NSAIDs. Acetaminophen does not inhibit COX in peripheral tissues and is less effective in the presence of peroxides. The active comparator treatment is oral doses of acetaminophen (1000 mg three times per day). Subjects will receive the first medication dose in the emergency department and will be given the remaining 5 doses to take over 48 hours as outpatients.
Drug: Acetaminophen
Acetaminophen 1000 mg orrally three times per day for two days for subjects who are randomized to the acetaminophen arm.
Other Name: tylenol




Primary Outcome Measures :
  1. Post-concussion symptoms [ Time Frame: 7 to 14 days after enrollment. ]
    The main outcome variables will be the incidence of post-concussion symptoms that will be measured using NIH Common Data Elements and Neuro-QOL instruments. The Neuro-QOL instruments were developed for the NIH by the Northwestern University Department of Medical Social Sciences to provide clinically relevant and psychometrically robust health-related quality of life assessment tools for patients with common neurological disorders. In addition, the Neuro-QOL measurement system provides item banks and short forms that enable patient reported outcome measurement in neurological research which minimizes patient burden.41-44 This information will be collected at 7 to 14 days after initial ED evaluation. Emphasis will be placed on the Neuro-QOL instruments that measure headache pain and cognitive function as these are the most common and concerning symptoms of mild TBI.


Secondary Outcome Measures :
  1. Adverse drug reactions [ Time Frame: 7 to 14 days after enrollment ]
    Information regarding adverse drug reactions (ADRs) will also be obtained during the follow up interview of the study subjects. This assessment will include questions regarding abdominal pain or discomfort and any allergic reaction (e.g., rash, swelling, or difficulty breathing).



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Closed head injury within the past 24 hours with history (loss of consciousness, amnesia, mechanism of injury such as motor vehicle collision or fall from height) or specific symptoms and signs (headache, vomiting, dizziness, head injury, short-term memory deficit, confusion, blurred vision, balance problems) that prompts computerized tomography (CT) brain evaluation as determined by an emergency physician.
  2. Age 21 through 60 years of age.
  3. Initial Glasgow Coma Score of 13 or greater at time of ED presentation with normal neurologic examination and Glasgow Coma Score of 15 within two hours of initial assessment.
  4. Normal neurologic examination in the emergency department except for symptoms and signs described above (e.g., no focal neurologic deficit).
  5. Normal brain and skull on CT scan in the ED.
  6. Working cellular phone (for follow up assessment).

Exclusion Criteria:

  1. Significant concomitant non-cranial injury requiring pain medication (e.g., facial fracture, severe extremity injury, major blunt trauma.)
  2. Any type of skull or cervical spine fracture.
  3. Post-traumatic seizure.
  4. Currently taking NSAIDS, acetaminophen, or other pain medications on a regular basis.
  5. Currently taking ANY coagulant medication (e.g., Plavix, aspirin, Xeralto, Coumadin).
  6. Any bleeding disorder, predisposition to bleeding, or history of gastrointestinal bleeding.
  7. Pregnancy.
  8. Clinical intoxication with alcohol or illicit medication.
  9. Chronic alcohol abuse.
  10. Any liver or renal dysfunction or failure.
  11. Justification of obtaining CT brain evaluation that included patient being intoxicated.
  12. Intolerance, allergy or adverse reaction to either ibuprofen or acetaminophen.
  13. Any current or previously diagnosed cardiovascular condition (e.g., hypertension, coronary arterial disease, myocardial infarct, angina, congestive heart failure, pulmonary embolism, deep venous thrombosis).
  14. Any current or previously diagnosed neurovascular condition (e.g., stroke, TIA, multiple sclerosis, seizure disorder).
  15. Any active cancer or malignancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443142


Contacts
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Contact: Ryan McConnell, BA 312 694 7000 rmcconn1@nm.org

Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Not yet recruiting
Chicago, Illinois, United States, 60045
Contact: Ryan McConnell    312-694-7000    rmcconn1@nm.org   
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
Investigators
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Principal Investigator: Demetrios N. Kyriacou, MD,PhD Northwestern University

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Responsible Party: Demetrios Kyriacou, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT02443142     History of Changes
Other Study ID Numbers: NorthwesternU
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: March 2015
Keywords provided by Demetrios Kyriacou, Northwestern University:
mild TBI
concussion
post-concussion syndrome
Additional relevant MeSH terms:
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Acetaminophen
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action