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

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 |

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.
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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.
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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 |
- 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.
- 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 |
Inclusion Criteria:
- 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.
- Age 21 through 60 years of age.
- 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.
- Normal neurologic examination in the emergency department except for symptoms and signs described above (e.g., no focal neurologic deficit).
- Normal brain and skull on CT scan in the ED.
- Working cellular phone (for follow up assessment).
Exclusion Criteria:
- Significant concomitant non-cranial injury requiring pain medication (e.g., facial fracture, severe extremity injury, major blunt trauma.)
- Any type of skull or cervical spine fracture.
- Post-traumatic seizure.
- Currently taking NSAIDS, acetaminophen, or other pain medications on a regular basis.
- Currently taking ANY coagulant medication (e.g., Plavix, aspirin, Xeralto, Coumadin).
- Any bleeding disorder, predisposition to bleeding, or history of gastrointestinal bleeding.
- Pregnancy.
- Clinical intoxication with alcohol or illicit medication.
- Chronic alcohol abuse.
- Any liver or renal dysfunction or failure.
- Justification of obtaining CT brain evaluation that included patient being intoxicated.
- Intolerance, allergy or adverse reaction to either ibuprofen or acetaminophen.
- Any current or previously diagnosed cardiovascular condition (e.g., hypertension, coronary arterial disease, myocardial infarct, angina, congestive heart failure, pulmonary embolism, deep venous thrombosis).
- Any current or previously diagnosed neurovascular condition (e.g., stroke, TIA, multiple sclerosis, seizure disorder).
- Any active cancer or malignancy.

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
Contact: Ryan McConnell, BA | 312 694 7000 | rmcconn1@nm.org |
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 |
Principal Investigator: | Demetrios N. Kyriacou, MD,PhD | Northwestern University |
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 |
mild TBI concussion post-concussion syndrome |
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 Acetaminophen 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 |