PISA. The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: Protocol for a phase II double-blind randomised placebo-controlled trial [ISRCTN98608690]

BACKGROUND: During the first days after stroke, one to two fifths of the patients develop fever or subfebrile temperatures. Body temperature is a strong prognostic factor after stroke. Pharmacological reduction of temperature in patients with acute ischaemic stroke may improve their functional outcome. Previously, we studied the effect of high dose (6 g daily) and low dose (3 g daily) paracetamol (acetaminophen) in a randomised placebo-controlled trial of 75 patients with acute ischemic stroke. In the high-dose paracetamol group, mean body temperature at 12 and 24 hours after start of treatment was 0.4°C lower than in the placebo group. The effect of ibuprofen, another potent antipyretic drug, on body-core temperature in normothermic patients has not been studied. AIM: The aim of the present trial is to study the effects of high-dose paracetamol and ibuprofen on body temperature in patients with acute ischaemic stroke, and to study the safety of these treatments. DESIGN: Seventy-five (3 × 25) patients with acute ischaemic stroke confined to the anterior circulation will be randomised to treatment with either: 400 mg ibuprofen, 1000 mg acetaminophen, or with placebo 6 times daily during 5 days. Body-temperatures will be measured with a rectal electronic thermometer at the start of treatment and after 24 hours. An infrared tympanic thermometer will be used to monitor body temperature at 2-hour intervals during the first 24 hours and at 12-hour intervals thereafter. The primary outcome measure will be rectal temperature at 24 hours after the start of treatment. The study results will be analysed on an intent-to-treat basis, but an on-treatment analysis will also be performed. No formal interim analysis will be carried out

Reproducibility of visual analog scale (VAS) pain scores to mechanical pressure

This study tested the reproducibility of visual analog scale (VAS) pain scores to measure changes in masseter muscle pain evoked by maximally tolerable mechanical stimulation over a short time period in healthy subjects. This study also evaluated gender differences in reproducibility of VAS scores to mechanical stimulation. Ten healthy female and eight healthy male individuals participated in this study. The recordings of VAS pain scores to an identical mechanical pressure on the masseter muscle were performed at three different sessions (T1, T2, and T3). The subjects rated their pain on a VAS to a maximally tolerable stimulus that was recorded on an algometer at the first session. The algometer pressure reading was recorded for each subject and then used to duplicate the same identical mechanical stimulus at each of the three sessions. This identical pressure was repeated in the same marked spot at six minutes and after 30 minutes. The subjects rated the pain on a VAS to this identical stimulus at each session. There was no significant difference in VAS pain scores of all subjects at T1, T2, and T3. There was no significant difference in reproducibility of VAS pain scores in females compared to males. Intraclass correlation coefficients were 0.811 on the right masseter and 0.844 on the left masseter. VAS pain scores to mechanical stimulation were reproducible over a short time period. Gender did not affect the reproducibility. This previously unreported method of measuring pain to repeated identical mechanical stimulation appears to have potential for both clinical and research application