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A double blind randomized pilot trial of naloxone in the treatment of acute ischemic stroke

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Abstract

Attention has focused on naloxone, an opiate receptor antagonist, because of its potential benefit in reversing neurological damage after acute cerebral ischemia. To evaluate the safety and possible efficacy of high-dose naloxone in ischemic stroke patients we planned a double blind pilot study. Between January 1989 and May 1990 24 patients were randomly assigned to the naloxone or placebo group according to age and neurological deficit. Naloxone was given in a loading dose of 5 mg/kg over 10 minutes followed by a 24-hour infusion at the rate of 3.5mg/kg/h. 10 patients experienced minor side effects but none of them had to discontinue the treatment. 9 patients improved: 6 in the naloxone group and 3 in the placebo group, but no significant difference was found using the non parametric Mann-Whitney test. Our study suggests that naloxone is safe at the dose used, but the results do not support the planning of similar trials on a larger scale.

Sommario

È stata posta grande attenzione sul Naloxone, un antagonista dei recettori degli oppiacei, e sulla sua potenziale utilità nel far regredire il danno neurologico dopo un'ischemia cerebrale acuta. Per valuatare la sicurezza e la possibile efficacia di alte dosi di naloxone nei pazienti con ictus ischemico, abbiamo programmato uno studio pilota in doppio cieco. Dal gennaio 1989 al maggio 1990 ventiquattro pazienti sono stati assegnati casualmente al gruppo Naloxone o a quello Placebo secondo l'età e il deficit neurologico. Il naloxone venne somministrato in una dose di carico di 5 mg/kg in 10 minuti seguita da un 'infusione di 24 ore (3.5 mg/kg/h). Dieci pazienti ebbero effetti collaterali minori ma nessuno di essi dovette interrompere il trattamento. Nove pazienti migliorarono: sei nel gruppo Naloxone e tre nel gruppo placebo, ma non fu trovata alcuna differenza significativa usando il test non parametrico di Mann-Whitney. Il nostro studio suggerisce che il naloxone è sicuro alla dose usata, ma i risultati non giustificano la pianificazione di trials più grandi con le stesse caratteristiche.

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Authors and Affiliations

  1. I Clinica Neurologica, Università di Bari, Piazza Giulio Cesare, 70124, Bari

    Federico F., Lucivero V., Lamberti P., Fiore A. & Conte C.

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  1. Federico F.
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  2. Lucivero V.
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  3. Lamberti P.
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  4. Fiore A.
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  5. Conte C.
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Federico, F., Lucivero, V., Lamberti, P. et al. A double blind randomized pilot trial of naloxone in the treatment of acute ischemic stroke. Ital J Neuro Sci 12, 557–563 (1991). https://doi.org/10.1007/BF02336951

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  • DOI: https://doi.org/10.1007/BF02336951

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