drugset / Trial / NCT01530880

Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage

NCT01530880

RandomizedParallel-groupOpen-labelTreatment

Summary

Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head injuries and is associated with poor recovery after injury. The current standard of care is to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can effectively reduce fever but results in a high rate of shivering. Shivering is stressful to the heart and can further worsen brain injury. Methods to combat shivering have been developed and are successful in limiting the stress in the majority of patients that use a body cooling device. However, the drugs used to control shivering are sedating and may also interfere with brain recovery. The purpose of this study is to assess whether ibuprofen given intravenously is more effective in combating fever than the current standard of care. Should results from this study demonstrate that ibuprofen infusion is effective, a larger study will be conducted to determine whether this aggressive fever control regimen leads to improved recovery after brain injury.

Timeline

Start
2012-10
Primary completion
2016-03-17
Completion
2016-03-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 650 mg Oral
Subject Ibuprofen Small molecule 85 mg Intravenous

Indications

No indication recorded.