Stroke Circulatory System Cerebrovascular diseases
Conditions
Interventions
1. Paracetamol 6 g daily, for 5 days
2. Ibuprofen 2.4 g daily, for 5 days
3. Placebo for 5 days
Sponsors
Erasmus Medical Center (The Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. An acute ischaemic anterior circulation stroke 2. A body temperature greater than 36.0°C or less than 39.0°C 3. A CT scan that is compatible with acute ischaemic stroke 4. A focal deficit without rapid improvement 5. A possibility to start treatment within 24 hours after stroke onset
Exclusion criteria
Exclusion criteria: 1. Severe aphasia, defined as an aphasia score of 2 or 3 on the National Institutes of Health Stroke Scale (NIHSS) 2. Treatment with an non-Steroidal Anti-Inflammatory Drug (NSAID) deemed necessary 3. Hypersensitivity to ibuprofen or paracetamol 4. (Chronic) liver failure or cirrhosis 5. (Chronic) renal failure 6. History of alcohol abuse 7. Active gastric ulcer disease or a history of peptic ulceration or gastro-intestinal haemorrhage in the preceding year 8. Colitis ulcerosa 9. Pregnancy 10. Use of corticosteroids 11. A severe concomitant medical condition that could affect the assessment of the effect of the study medication on temperature 12. Residual neurological impairment resulting from a previous stroke that may hamper the assessment of functional outcome 13. Death appearing imminent 14. No informed consent given
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body temperature at 24 hours from start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in baseline temperature at 1 and 5 days from start of treatment 2. Time with elevated body temperature (greater than 37.0°C) (area under the curve) during the first 24 hours and the first five days Tertiary outcomes: Functional outcome at one month, as determined by the scores on the modified Rankin Scale (mRS) and Barthel Index (BI). | — |
Countries
Netherlands
Outcome results
None listed