The Emergency Department is staffed exclusively by board-certified emergency medicine physicians that also supervise the care of 48 residents and four fellows.
Data Analyses Plan. We will conduct all statistical analyses based on the American Statistical Association Ethical Guidelines for Statistical Practice67,68 and include the following:. Sample Size Estimation. Sample size estimation is especially challenging because there are no prior human studies measuring the effect of COX-2 inhibition on the incidence of mild TBI symptoms. Notwithstanding this limitation, we will use the presence of headache pain at 7 to 14 days as a binary outcome.
With these assumptions, the estimated number of study subjects needed to statistically assess ibuprofen versus acetaminophen for the treatment of mild TBI is a total of subjects. The experimental treatment oral doses of either ibuprofen 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 mg orally three times per day for two days for study subjects who are randomized to the ibuprofen arm.
The active comparator treatment is oral doses of acetaminophen mg three times per day. Drug: Acetaminophen Acetaminophen mg orrally three times per day for two days for subjects who are randomized to the acetaminophen arm. 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. 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 : 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.
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Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. First Posted : May 13, Last Update Posted : November 13, Study Description. Traumatic brain injury TBI is an important public health problem with an estimated 1.
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.
Show detailed description. Hide detailed description. Detailed Description:. We will conduct all statistical analyses based on the American Statistical Association Ethical Guidelines for Statistical Practice67,68 and include the following: Univariate Analyses.
We will first conduct univariate analyses to assess potential demographic and clinical differences between the two treatment groups. We will also use ANOVA to compare the effects of ibuprofen versus acetaminophen treatment on the incidence of mild TBI symptoms using continuous measures of pain scores and Neural-QOL measures of pain and cognitive function.
Thankfully, an increased awareness has prompted an increase in diagnosis of concussive injuries. Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. But what exactly is a concussion? During that process, and depending on what part of the brain was impacted, it can affect different functions like balance , memory, focus or even cause visual disturbances. When you hit your head, the neck can take on some of that force as well.
Symptoms can change over time, depending on activity level and with other potentially associated injuries, making them difficult to recognize and manage. That was a rhetorical question. It's a mixed bag Some research says that there are protective effects and benefits in post-concussion migraine, while other research suggests that chronic NSAID use makes cognitive outcomes of concussion worse. The same research that suggests benefit in migraine also says:. Ultimate, medications should probably NOT be considered in concussion care.
If you're considering reaching for an Ibuprofen after a concussion it's most likely because you're dealing with some sort of head, neck, or shoulder pain. Headache is one of the most common symptoms in concussion, and it can be shockingly simple to make progress with your headaches.
When looking at concussion there are five big buckets that we can divide up recovery into:. When dealing with post-traumatic headaches or pains related to your concussion each of these factors may influence your ability to recover and feel like yourself. Make integrative and comprehensive concussion care affordable and accessible.
Provide athletic and brain performance exercises to optimize life, work, and sports performance while minimizing the risk of injury. His office is located in Scottsdale, AZ. Ellis, M. Multi-disciplinary management of athletes with post-concussion syndrome: an evolving pathophysiological approach. Frontiers in neurology , 7 , Hall, E.
Antioxidant therapies for traumatic brain injury.
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