Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury (IVAMTBI)
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|ClinicalTrials.gov Identifier: NCT02443142|
Recruitment Status : Withdrawn (Lack of study participants.)
First Posted : May 13, 2015
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion||Drug: Ibuprofen Drug: Acetaminophen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury|
|Study Start Date :||May 1, 2015|
|Actual Primary Completion Date :||July 1, 2016|
|Actual Study Completion Date :||July 1, 2016|
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.
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.
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).
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
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60045|
|Principal Investigator:||Demetrios N. Kyriacou, MD,PhD||Northwestern University|