Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Northwestern Memorial Hospital
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

1. 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.

2. Age 21 through 60 years of age.

3. 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.

4. Normal neurologic examination in the emergency department except for symptoms and signs described above (e.g., no focal neurologic deficit).

5. Normal brain and skull on CT scan in the ED.

6. Working cellular phone (for follow up assessment).

Exclusion Criteria:

1. Significant concomitant non-cranial injury requiring pain medication (e.g., facial fracture, severe extremity injury, major blunt trauma.)

2. Any type of skull or cervical spine fracture.

3. Post-traumatic seizure.

4. Currently taking NSAIDS, acetaminophen, or other pain medications on a regular basis.

5. Currently taking ANY coagulant medication (e.g., Plavix, aspirin, Xeralto, Coumadin).

6. Any bleeding disorder, predisposition to bleeding, or history of gastrointestinal bleeding.

7. Pregnancy.

8. Clinical intoxication with alcohol or illicit medication.

9. Chronic alcohol abuse.

10. Any liver or renal dysfunction or failure.

11. Justification of obtaining CT brain evaluation that included patient being intoxicated.

12. Intolerance, allergy or adverse reaction to either ibuprofen or acetaminophen.

13. Any current or previously diagnosed cardiovascular condition (e.g., hypertension, coronary arterial disease, myocardial infarct, angina, congestive heart failure, pulmonary embolism, deep venous thrombosis).

14. Any current or previously diagnosed neurovascular condition (e.g., stroke, TIA, multiple sclerosis, seizure disorder).

15. Any active cancer or malignancy.