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Comparison of Dexketoprofen Trometamol and Dipyrone in the Treatment of Renal Colic

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Abstract

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely used for pain relief in patients with renal colic. Dexketoprofen trometamol is an NSAID that has demonstrated good analgesic efficacy and a good safety profile after oral administration in different models of acute and chronic pain.

Objective: To assess the analgesic efficacy and safety of single intramuscular doses of dexketoprofen trometamol (25 and 50mg) compared with dipyrone (2g) in moderate to severe pain due to renal colic.

Study design: Multicentre, randomised, double-blind, parallel-group study.

Patients: Patients of both sexes aged 18–70 years with a diagnosis of renal colic were eligible for randomisation if they presented with at least moderate pain as assessed by visual analogue scale (VAS) scoring ≥40mm on a scale of 100mm immediately before study drug administration.

Methods: Assessment of analgesic efficacy was done using standard pain intensity and pain relief scales. Total scores from baseline to 6 hours after study drug administration were calculated for the sum of pain intensity differences relative to baseline (SPID), sum of analogue pain intensity differences relative to baseline (SAPID) and total pain relief scores (TOTPAR) as primary efficacy endpoints. Secondary efficacy and safety variables were also analysed.

Results: A total of 333 patients (dexketoprofen 25mg, n = 112; dexketoprofen 50mg, n = 113; dipyrone 2g, n = 108) were included in the study. No significant differences were found between the treatment groups with regard to SPID (p = 0.797), SAPID (p = 0.852) and TOTPAR (p = 0.716). The time-effect course for pain intensity differences and pain relief showed significantly (p < 0.05) higher values for both doses of dexketoprofen trometamol compared with dipyrone during the first hour after treatment administration. More than 90% of the patients in all three groups achieved pain relief of at least 50% as compared with baseline. Similarly, over 70% of the patients in all three groups considered the received treatment as excellent or good in the overall assessment of efficacy at the end of the study. No dose-effect relationship was observed in this pain model between both doses of dexketoprofen trometamol. All three treatments were well tolerated, showing mostly mild to moderate adverse events.

Conclusion: Dexketoprofen trometamol is a good analgesic for the treatment of moderate to severe pain due to renal colic, with a good safety profile and an efficacy comparable to that of dipyrone. The significantly greater effect of dexketoprofen trometamol early after administration suggests a faster onset of action, which can be of paramount importance in this condition.

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  1. 1 Use of tradenames is for product identification only and does not imply endorsement;

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Acknowledgements

This study was sponsored by Menarini Research. The authors thank Marta Pulido, MD, for editing the manuscript and for editorial assistance.

Participating investigators of the Dexketoprofen Renal Colic Study Group are: J. Sánchez-Carpena, Hospital Universitario Dr. Peset, Valencia; M. Mariné Blanco, Hospital de El Escorial, Madrid; C. Sánchez Juan, Hospital de Sagunto, Valencia; J. Rico Salvadó, Hospital de la Creu Roja, Barcelona; S. Tomás Vecina, Hospital Mútua de Terrassa, Barcelona; J.C. Gordillo Ballesteros, Hospital de Terrassa, Barcelona; F. Roqueta Egea, Centre Hospitalari Unitat Coronària de Manresa, Manresa, Barcelona; J. Sesma Sánchez, Hospital Virgen del Camino, Pamplona; J.A. Serrano Martínez, Hospital Morales Messeguer, Murcia; C. Galbán Rodríguez, Hospital Gil Casares, Santiago de Compostela, and A. Martín Joven, Policlínico de Vigo, S.A., Pontevedra, Spain. P. Jerntrop, Akutkliniken Universitetssjukhuset MAS, Malmo, and G. Persson, Akutenheten Länssjukhuset Ryhov, Jönköping, Sweden. M. Leivonen, Peijas Hospital, Vantaa; J. Kallio, Tampere University Hospital, Tampere; M. Multanen, Päijät-Häme Central Hospital, Lahti, and E. Wuokko, Maria Hospital, Helsinki, Finland.

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Authors and Affiliations

  1. Emergency Department, Hospital Universitario Dr Peset, Valencia, Spain

    Juan Sánchez-Carpena

  2. Emergency Department, Hospital Virgen del Camino, Pamplona, Navarra, Spain

    Javier Sesma-Sánchez

  3. Emergency Department, Hospital de Sagunto, Valencia, Spain

    Carlos Sánchez-Juan

  4. Emergency Department, Hospital Mútua de Terrassa, Barcelona, Spain

    Santiago Tomás-Vecina

  5. Emergency Department, Hospital de Terrassa, Barcelona, Spain

    Dolors García-Alonso

  6. Emergency Department, Hospital de la Creu Roja L’Hospitalet de Llobregat, Barcelona, Spain

    Jordi Rico-Salvadó

  7. Menarini Research, Florence, Italy

    Mónica Forns, Marta Mas, Isabel Paredes &  Remei Artigas

  8. Barcelona, Spain

    Mónica Forns, Marta Mas, Isabel Paredes &  Remei Artigas

  9. Laboratorios Menarini, SA, Clinical Research, C/ Alfons XII 587, E-08918, Badalona, Barcelona, Spain

    Remei Artigas

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  1. Juan Sánchez-Carpena

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Correspondence to Remei Artigas.

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Sánchez-Carpena, J., Sesma-Sánchez, J., Sánchez-Juan, C.et al. Comparison of Dexketoprofen Trometamol and Dipyrone in the Treatment of Renal Colic.Clin. Drug Investig.23, 139–152 (2003). https://doi.org/10.2165/00044011-200323030-00001

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