Introduction: Aim of this randomized prospective clinical trial is to compare two methods of antipyretics and evaluate their efficacy in controlling fever during the acute phase of brain damage.
Methods: Twenty-two febrile comatose patients: 12 severe traumatic brain injury and 10 subarachnoid hemorrhage divided in 2 groups: Diclofenac low-dose infusion (10 patients) and extemporaneous boluses of NSAIDs (CTRL, 12 patients). The primary outcome measure was length of time with temperature>38 degrees C. Secondary outcome measures were: 1) to assess the effects of each antipyretic strategy on intracranial pressure (ICP), cerebral perfusion pressure (CPP), mean arterial pressure (MAP) and heart rate; 2) to monitor adverse effects of each antipyretic strategy. The baseline characteristics in the two treatment groups were similar.
Results: Primary findings: percentage of time per patient with temperature>38 degrees C was significantly lower (P<0.0001) in the DCF group, 4% (0-22%), vs. 34% (8-56%) in CTRL group. In addition, mean T degrees , max T degrees were lower in DCF than in CTRL (P<0.05). Secondary findings: CPP and MAP were significantly higher in DCF group (P<0.05) while ICP was not different (NS). However, if ICP pre randomization was <25 mmHg, CTRL suffered a worst ICP (24+/-11 vs. 16+/-7 P=0.01), MAP (89+/-10 vs. 104+/-10 P=0.01) and CPP (75+/-10 vs. 94+/-17 P=0.01) compared to DCF. No differences between the two treatment were recorded when ICP>or=25 mmHg before randomization. There was no gastrointestinal or intracranial bleeding.
Conclusions: Low dose DCF infusion is a potential useful strategy for a successful control temperature better than intermittent NSAIDs dosing, minimizing potentially brain-damaging effects of fever.