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Blood, 29 October 2009, Vol. 114, No. 18, pp. 3742-3747.
Prepublished online as a Blood First Edition Paper on August 28, 2009; DOI 10.1182/blood-2009-06-227330.


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Submitted June 12, 2009
Accepted August 5, 2009

A randomized, controlled clinical trial of ketoprofen for sickle-cell disease vaso-occlusive crises in adults

Pablo Bartolucci, Tony El Murr, Francoise Roudot-Thoraval, Anoosha Habibi, Aline Santin, Bertrand Renaud, Violaine Noel, Marc Michel, Dora Bachir, Frederic Galacteros, and Bertrand Godeau*

Service de Medecine Interne, Hopital Henri-Mondor, Assistance Publique-Hopitaux de Paris, Universite Paris 12, Creteil, France
Service d'Epidemiologie, Hopital Henri-Mondor, Assistance Publique-Hopitaux de Paris, Universite Paris 12, Creteil, France
Service de Reference de la Drepanocytose, Hopital Henri-Mondor, Assistance Publique-Hopitaux de Paris, Universite Paris 12, Creteil, France
Service d'Accueil des Urgences, Hopital Henri-Mondor, Assistance Publique-Hopitaux de Paris, Universite Paris 12, Creteil, France

* Corresponding author; email: bertrand.godeau{at}hmn.aphp.fr.

Vaso-occlusive crisis (VOC) is the primary cause of hospitalization of patients with sickle-cell disease. Treatment mainly consists of intravenous morphine, which has many dose-related side effects. Nonsteroidal antiinflammatory drugs have been proposed to provide pain relief and decrease the need for opioids. Nevertheless, only a few underpowered trials of NSAID for sickle-cell VOC have been conducted and conflicting results were reported. We conducted a phase 3, double-blind, randomized, placebo-controlled trial with ketoprofen (300 mg/day for 5 days), a nonselective cyclooxygenase inhibitor, for severe VOC in adults. A total of 66 VOC episodes were included. The primary efficacy outcome was VOC duration. The secondary end points were morphine consumption, pain relief and treatment failure. Seven VOC episodes in each group were excluded from the analysis because of treatment failures. No significant between-group differences were observed for the primary outcome or the secondary end points. Thus, although ketoprofen was well-tolerated, it had no significant efficacy as treatment of VOC requiring hospitalization. These findings argue against its systematic use in this setting.


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