Analgesic Efficacy of Low Doses of Dexketoprof en in the Dental Pain Model: A Randomised, Double-Blind, Placebo-Controlled Study: Clinical Drug Investigation

C. Gay, E. Planas, M. Donado, J.M. Martínez, R. Artigas, F. Torres, D. Mauleón, G. Carganico

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38 Citations (Scopus)

Abstract

Dexketoprofen (S(+)-2-(3-benzoylphenyl)propionic acid) is the active enantiomer of ketoprofen, a racemic nonsteroidal anti-inflammatory drug with proven analgesic activity in the treatment of pain, including acute pain after dental surgery. The aim of this randomised, double-blind study was to compare the analgesic efficacy of single oral doses (5, 10 and 20mg) of the tromethamine salt of dexketoprofen (DKP.TRIS) [equivalent to 3.5, 7 and 14mg of dexketoprofen, respectively] with that of placebo in the dental pain model. Ibuprofen (400mg) was used to validate the model. A total of 206 patients experiencing moderate to severe pain after surgical removal of the impacted third molar tooth under local anaesthesia were entered in this trial at 2 centres. Patients rated their pain intensity and pain relief on verbal rating and visual analogue scales at regular intervals during the 6-hour period after drug administration. Patients were also requested to provide a global evaluation of treatment efficacy at the end of the observation period. DKP.TRIS (10 and 20mg) and ibuprofen were superior to placebo as determined by significantly higher values for the sum of the pain intensity difference scores and total pain relief scores from baseline. Furthermore, the time to reduce baseline pain by at least 50% was significantly more rapid in patients treated with DKP.TRIS (10 and 20mg) and ibuprofen than in placebo recipients. The mean time to remedication with rescue analgesia was significantly longer in all active treatment groups compared with placebo. DKP.TRIS was well tolerated, with a reported incidence of adverse events similar to that of placebo. No serious adverse events were reported in any treatment group. The results of this study suggest that DKP.TRIS is an effective analgesic with a favourable tolerability profile for the treatment of acute pain states.
Original languageEnglish
Pages (from-to)320-330
Number of pages11
JournalClinical Drug Investigation
Volume11
Issue number6
DOIs
Publication statusPublished - Jun 1996

Keywords

  • analgesic agent
  • dexketoprofen
  • ibuprofen
  • nonsteroid antiinflammatory agent
  • adult
  • analgesia
  • analgesic activity
  • article
  • bleeding
  • clinical trial
  • cold sensation
  • controlled clinical trial
  • controlled study
  • dental surgery
  • double blind procedure
  • drug efficacy
  • drug tolerability
  • female
  • fever
  • headache
  • hematoma
  • human
  • local anesthesia
  • major clinical study
  • male
  • molar tooth
  • multicenter study
  • nausea
  • oral drug administration
  • otalgia
  • pain
  • priority journal
  • randomized controlled trial
  • skin manifestation
  • sore throat
  • tooth pain
  • vertigo

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