Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury
Status:
Withdrawn
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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.