Abstract
Objective
The aim of this study was to assess the efficacy and safety of a single intravenous (i.v.) bolus of dexketoprofen trometamol compared with an i.v. infusion of dipyrone in patients with moderate to severe pain due to renal colic.
Methods
A total of 308 patients with renal colic and visual analog scale (VAS) score ≥40 mm participated in a multicenter, randomized, double blind, double-dummy, parallel, and active-controlled study and were randomized to dexketoprofen 25 mg (n = 101), dexketoprofen 50 mg (n = 104), and dipyrone 2 g (n = 103).
Results
Mean [± standard deviation (SD)] total pain relief (TOTPAR) scores were similar in the dexketoprofen 50 mg (15.3 ± 8.6) and dipyrone (15.5 ± 8.6) and slighly higher than in dexketoprofen 25 mg (13.5 ± 8.6), although significant differences were not achieved. In the same way, patients in the dexketoprofen 50 mg and dipyrone groups showed higher scores in the sum of pain intensity differences (SPID) and the sum of analogue pain intensity differences (SAPID) than patients in the dexketoprofen 25 mg group, reaching statistical significance in comparison with dexketoprofen 25 mg and dipyrone for SPID and SAPID (p < 0.05). The time–effect course for pain intensity differences and pain relief showed significantly higher values for both doses of dexketoprofen during the first 30 min after drug administration (p < 0.05). Dexketoprofen 50 mg and dipyrone groups had 66% and 70%, respectively, of patients with at least 50% of maximum obtainable TOTPAR in comparison with 56% in the dexketoprofen 25 mg group. The study medications were well tolerated.
Conclusions
Dexketoprofen 50 mg administered as a single i.v. bolus was effective for the relief of moderate to severe pain in patients with renal colic, with a good safety profile and efficacy similar to i.v. dipyrone 2 g. Dexketoprofen produced analgesia that was faster in onset.
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Acknowledgments
This study was financially supported by a grant from the Menarini Group. The authors have no conflicts of interest directly relevant to the content of this study. The authors thank Marta Pulido MD for editing the manuscript and editorial assistance, and Silvia Garrido for the technical support.
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Dexketoprofen Renal Colic Study Group: S. Tomás Vecina, Hospital Mútua de Terrassa, Barcelona; Ma L. Recuero Sánchez, Hospital del Insalud de Mérida, Badajoz; R. Bugarín González, Hospital Clínico Universitario, Santiago de Compostela, E. Gene Tous, Corporació Sanitària Parc Taulí, Sabadell, Barcelona; JA. Mota Gracia, Hospital Rafael Méndez, Murcia; A. Román Jasanada, Hospital General Universitario de Guadalajara, Guadalajara; Sonia González, Fundación Hospital Alcorcón, Alcorcón, Madrid; D. García Alonso, Consorci Sanitari de Terrassa, Terrassa, Barcelona; L García González, Consorci Sanitari Integral, Hospital General de l’Hospitalet de Llobregat, Barcelona; J. Sánchez Carpena, Hospital Universitario Dr. Peset, Valencia; M. Mariné Blanco, Hospital de El Escorial, El Escorial, Madrid; F, Roqueta Egea, Fundació Althaia — Xarxa Assistencial de Manresa, Manresa, Barcelona; J. A. Serrano Martínez, Hospital General Universitario Morales Messeguer, Murcia; G. Ferrán Martínez, Hospital General de Castellón, Castellón; A. Martín Joven, Policlínica de Vigo, S.A, Pontevedra; M.L. Mosteiro Álvarez, Hospital de Montecelo, Pontevedra; and F. Domínguez Hervella, Complejo Hospitalario Cristal Piñor, Ourense.
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Sánchez-Carpena, J., Domínguez-Hervella, F., García, I. et al. Comparison of intravenous dexketoprofen and dipyrone in acute renal colic. Eur J Clin Pharmacol 63, 751–760 (2007). https://doi.org/10.1007/s00228-007-0322-4
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DOI: https://doi.org/10.1007/s00228-007-0322-4