PAIS: Paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN 74418480]

BMC Cardiovascular Disorders

Volumn 5, Issue , 2005, Pages

  van Breda, Eric J ^a   van der Worp, H Bart ^b   van Gemert, H Maarten A ^c   Algra, Ale ^b   Kappelle, L Jaap ^b   van Gijn, Jan ^b   Koudstaal, Peter J ^a   Dippel, Diederik W J ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c MEANDER MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

PARACETAMOL; PLACEBO; ANALGESIC AGENT;

ARTICLE; BODY TEMPERATURE; CEREBROVASCULAR ACCIDENT; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; GASTROINTESTINAL HEMORRHAGE; HUMAN; LIVER FAILURE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; SYMPTOMATOLOGY; COMPARATIVE STUDY; DRUG EFFECT; FEVER; MULTICENTER STUDY (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); TRANSIENT ISCHEMIC ATTACK;

ACETAMINOPHEN; ANALGESICS, NON-NARCOTIC; BODY TEMPERATURE; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; FEVER; HUMANS; ISCHEMIC ATTACK, TRANSIENT; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STROKE;

EID: 26844556082     PISSN: 14712261     EISSN: 14712261     Source Type: Journal    
DOI: 10.1186/1471-2261-5-24     Document Type: Article

References (37)

1. Azzimondi G, Bassein L, Nonino F, Fiorani L, Vignatelli L, Re G, D'Alessandro R: Fever in acute stroke worsens prognosis. A prospective study. Stroke 1995, 26:2040-2043.
2. Castillo J, Martinez F, Leira R, Prieto JM, Lema M, Noya M: Mortality and morbidity of acute cerebral infarction related to temperature and basal analytic parameters. Cerebrovasc Dis 1994, 4:66-71.
3. Castillo J, Davalos A, Marrugat J, Noya M: Timing for fever-related brain damage in acute ischemic stroke. Stroke 1998, 29:2455-2460.
4. Fukuda H, Kitani M, Takahashi K: Body temperature correlates with functional outcome and the lesion size of cerebral infarction. Acta Neurol Scand 1999, 100:385-390.
5. Reith J, Jorgensen HS, Pedersen PM, Nakayama H, Raaschou HO, Jeppesen LL, Olsen TS: Body temperature in acute stroke: relation to stroke severity, infarct size, mortality, and outcome. Lancet 1996, 347:422-425.
6. Wang Y, Lim LL, Levi C, Heller RF, Fisher J: Influence of admission body temperature on stroke mortality. Stroke 2000, 31:404-409.
7. Dippel DWJ, van Breda EJ, Van Gemert HMA, van der Worp HB, Meijer RJ, Kappelle LJ, Koudstaal PJ: Effect of paracetamol (acetaminophen) on body temperature in acute ischemic stroke: a double-blind, randomized phase II clinical trial. Stroke 2001, 32:1607-1612.
8. van Breda EJ, van der Worp HB, Van Gemert HMA, Meijer RJ, Kappelle LJ, Koudstaal PJ, Dippel DWJ: 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. BMC Cardiovascular Disorders 2002, 2:7.
9. Dippel DWJ, van Breda EJ, van der Worp HB, van Gemert HM, Meijer RJ, Kappelle LJ, Koudstaal PJ: Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]. BMC Cardiovascular Disorders 2003, 3:2.
10. Dippel DWJ, van Breda EJ, van der Worp HB, van Gemert HM, Kappelle LJ, Algra A, Koudstaal PJ: Timing of the effect of acetaminophen on body temperature in patients with acute ischemic stroke. Neurology 2003, 61:677-679.
11. Clissold SP: Paracetamol and phenacetin. Drugs 1986, 32(Suppl 4):46-59.
12. Blume H, Ali SL, Elze M, Kramer J, Scholz ME: [The relative bioavailability of paracetamol in suppositories in comparison to tablets]. Arzneimittelforschung 1996, 46:975-980.
13. Adams HP Jr, Adams RJ, Brott T, del Zoppo GJ, Furlan A, Goldstein LB, Grubb RL, Higashida R, Kidwell C, Kwiatkowski TG, Marler JR, Hademenos GJ: Guidelines for the early management of patients with ischemic stroke: A scientific statement from the Stroke Council of the American Stroke Association. Stroke 2003, 34:1056-1083.
14. Broderick JP, Adams HP Jr, Barsan W, Feinberg W, Feldmann E, Grotta J, Kase C, Krieger D, Mayberg M, Tilley B, Zabramski JM, Zuccarello M: Guidelines for the management of spontaneous intracerebral hemorrhage: A statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke 1999, 30:905-915.
15. Moher D, Schulz KF, Altman D: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001, 285:1987-1991.
16. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J: Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988, 19:604-607.
17. Mahoney FI, Barthel DW: Functional evaluation: the Barthel index. MD State Med J 1965, 14:61-65.
18. The EuroQol Group: EuroQol: a new facility for the measurement of health related quality of life. Health Policy 1990, 16:199-208.
19. Dolan P: Modeling valuations for EuroQol health states. Medical Care 1997, 35:1095-1108.
20. Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V: Measurements of acute cerebral infarction: a clinical examination scale. Stroke 1989, 20:864-870.
21. Adams HPJ, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE: Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke 1993, 24:35-41.
22. Hernandez AV, Steyerberg EW, Habbema JD: Covariate adjustment in randomized controlled trials with dichotomous outcomes increases statistical power and reduces sample size requirements. J Clin Epidemiol 2004, 57:454-460.
23. International Stroke Trial Collaborative Group: The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. Lancet 1997, 349:1569-1581.
24. Jorgensen HS, Reith J, Pedersen PM, Nakayama H, Olsen TS: Body temperature and outcome in stroke patients. Lancet 1996, 348:193.
25. Hajat C, Hajat S, Sharma P: Effects of poststroke pyrexia on stroke outcome : a meta-analysis of studies in patients. Stroke 2000, 31:410-414.
26. Schwarz S, Hafner K, Aschoff A, Schwab S: Incidence and prognostic significance of fever following intracerebral hemorrhage. Neurology 2000, 54:354-361.
27. Boysen G, Christensen H: Stroke Severity Determines Body Temperature in Acute Stroke. Stroke 2001, 32:413-417.
28. Schaller B, Graf R: Hypothermia and stroke: the pathophysiological background. Pathophysiology 2003, 10:7-35.
29. Miyazawa T, Tamura A, Fukui S, Hossmann KA: Effect of mild hypothermia on focal cerebral ischemia. Review of experimental studies. Neurol Res 2003, 25:457-464.
30. Clifton GL, Miller ER, Choi SC, Levin HS, McCauley S, Smith KR, Muizelaar JP, Wagner FC, Marion DW, Luerssen TG, Chesnut RM, Schwartz M: Lack of effect of induction of hypothermia after acute brain injury. N Engl J Med 2001, 344:556-563.
31. Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K: Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med 2002, 346:557-563.
32. The Hypothermia after Cardiac Arrest Study Group: Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med 2002, 346:549-556.
33. Kammersgaard LP, Rasmussen BH, Jorgensen HS, Reith J, Weber U, Olsen TS: Feasibility and safety of inducing modest hypothermia in awake patients with acute stroke through surface cooling: A case-control study: the Copenhagen Stroke Study. Stroke 2000, 31:2251-2256.
34. Meijer RJ, Visser H, Koudstaal PJ, Dippel DWJ: Lowering body temperature in acute ischemic stroke without artificial ventilation and heavy sedation: a feasibility study. J Stroke Cerebrovasc Dis 2001, 10:157-160.
35. Schwab S, Georgiadis D, Berrouschot J, Schellinger PD, Graffagnino C, Mayer SA: Feasibility and safety of moderate hypothermia after massive hemispheric infarction. Stroke 2001, 32:2033-2035.
36. De Georgia MA, Krieger DW, Abou-Chebl A, Devlin TG, Jauss M, Davis SM, Koroshetz WJ, Rordorf G, Warach S: Cooling for Acute Ischemic Brain Damage (COOL AID): a feasibility trial of endovascular cooling. Neurology 2004, 63:312-317.
37. Hacke W, Kaste M, Bogousslavsky J, Brainin M, Chamorro A, Lees K, Leys D, Kwiecinski H, Toni P, Langhorne P, Diener C, Hennerici M, Ferro J, Sivenius J, Gunnar N, Bath P, Olsen TS, Gugging M: European Stroke Initiative Recommendations for Stroke Management-update 2003. Cerebrovasc Dis 2003, 16:311-337.