The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: a phase II double-blind randomised placebo-controlled trial

Completed

• Conditions: Stroke; Circulatory System; Cerebrovascular diseases

• Registration Number: ISRCTN98608690
• Lead Sponsor: Erasmus Medical Center (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified