Onset of analgesia by a topically administered flurbiprofen lozenge: a randomised controlled trial using the double stopwatch method

Autor: Bernard P. Schachtel, E. Schachtel, Tim Shea, Mary Beth Lorton, Sue Aspley, Adrian Shephard
Rok vydání: 2018
Předmět:
Zdroj: British Journal of Pain. 12:208-216
ISSN: 2049-4645
2049-4637
DOI: 10.1177/2049463718756152
Popis: Background: The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs. Objective: The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge. Methods: Adults with acute sore throat (n = 122) were examined to confirm the presence of tonsillopharyngitis (Tonsillo-Pharyngitis Assessment) and sore throat pain of at least moderate intensity (≥6 on a 0–10 Sore Throat Scale). Lozenges containing flurbiprofen 8.75 mg or inert ingredients (identically flavoured) were administered under double-blind conditions in the clinic while patients assessed pain and pain relief over 3 hours. Onset of analgesia was determined using the DSW method and reported as the Kaplan–Meier median time to meaningful relief. The median time to first perceived relief was also documented. Results: About 78% of flurbiprofen-treated patients reported meaningful pain relief compared with 48% of placebo-treated patients (p Conclusion: These results indicate that the DSW method can be successfully applied to the evaluation of the onset of action of a locally administered analgesic in patients with acute sore throat, demonstrating that the onset of action (time to meaningful pain relief) of flurbiprofen lozenge was
Databáze: OpenAIRE
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