Clinical Trial: Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury

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.

Detailed Summary:

OBJECTIVES

The long-term goal of the proposed project is to develop an effective pharmacological therapy for patients with mild TBI to improve functional outcomes. The main objective is to compare the effects of ibuprofen versus acetaminophen for reducing the short-term development post-concussion symptoms in patients with mild TBI. We will conduct a double-blinded randomized clinical trial (RCT) with the specific aim of measuring the comparative effects of equipotent doses of ibuprofen versus acetaminophen on the incidence of concussion symptoms to be measured 7 to 10 days after mild TBI in emergency department patients with isolated closed head injury. The main study hypothesis of our research project is that patients with mild TBI who are treated with ibuprofen will have a lower incidence of post-concussion symptoms compared to patients treated with acetaminophen. The proposed investigation is novel because it will be the very first RCT to compare analgesic medications for the specific treatment of mild TBI.

BACKGROUND

Pathophysiology of Mild TBI. TBI results from external mechanical force applied to the cranium leading to parenchymal brain damage. This resultant brain injury can range from mild temporary impairment to severe disability. TBI transpires in two phases: (1) primary brain injury occurs at the moment of the application of mechanical force on the cranium and results in lacerations, contusions, hematomas and shearing injuries of the brain; and (2) secondary brain injury begins immediately after the primary brain injury and results from the cellular mediation of neuroinflammation.15,16 The principal injury of mild TBI is diffuse axonal injury from shearing forces that is not usually identified by CT brain scan.17-20 Secondary brain injury activates multiple cell
Sponsor: Northwestern University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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).


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: May 11, 2015
Date Started: May 2015
Date Completion: December 2015
Last Updated: May 12, 2015
Last Verified: March 2015