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Oral Diclofenac Dispersible Provides a Faster Onset of Analgesia than Intramuscular Ketorolac in the Treatment of Postoperative Pain

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Summary

The objective of this study was to compare the efficacy and tolerability of single doses of a new oral formulation, diclofenac dispersible, with parenteral ketorolac in patients with postoperative pain following orthopaedic surgery. In this double-blind, double-dummy, between-patient study, 55 adult inpatients experiencing moderate-to-severe pain within 2 hours after surgery were randomly allocated to receive diclofenac dispersible 50mg orally or ketorolac 30mg intramuscularly. The primary efficacy variable was pain intensity at 15 minutes. Secondary efficacy variables included pain relief and global evaluation of efficacy by patient and investigator. Diclofenac dispersible was significantly superior to ketorolac with respect to the primary efficacy variable (p = 0.012). The area under the pain intensity-time curve from zero to 6 hours (AUC0–6) for reduction in pain intensity and the peak intensity difference values were also superior for diclofenac, although the differences just failed to reach statistical significance (p = 0.06). Pain relief scores were clinically and numerically superior in diclofenac recipients compared with ketorolac recipients over the 6-hour observation period. AUC0–6 for pain relief was significantly higher for the diclofenac-treated group compared with ketorolac-treated patients (p = 0.0002). Both treatments were well tolerated.

In conclusion, these data show diclofenac dispersible to have a faster onset of action and superior efficacy overall compared with intramuscular ketorolac in the management of pain after orthopaedic surgery. Diclofenac dispersible therefore provides a new oral alternative to parenteral nonsteroidal anti-inflammatory agents in the management of postoperative pain.

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Authors and Affiliations

  1. Istituto di Ortopedia e Traumatologia, Università Cattolica del Sacro Cuore, Roma, Italy

    Gianfranco Fineschi & Francesco Ciro Tamburrelli

  2. Medical Department, Ciba Italy, S.S. 233 Km 20.500, 21040, Origgio (VA), Italy

    Bianca Maria Francucci &  Roberto Pisati

Authors
  1. Gianfranco Fineschi
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  2. Francesco Ciro Tamburrelli
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  3. Bianca Maria Francucci
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  4. Roberto Pisati
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Fineschi, G., Tamburrelli, F.C., Francucci, B.M. et al. Oral Diclofenac Dispersible Provides a Faster Onset of Analgesia than Intramuscular Ketorolac in the Treatment of Postoperative Pain. Clin. Drug Invest. 13, 1–7 (1997). https://doi.org/10.2165/00044011-199713010-00001

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  • DOI: https://doi.org/10.2165/00044011-199713010-00001

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