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ANALGESIA

Analgesic Effect of Sustained-Release Flurbiprofen Administered at the Site of Tissue Injury in the Oral Surgery Model

Raymond A. Dionne, DDS, PhD, Duncan Haynes, PhD, Jaime S. Brahim, DDS, MS, Janet S. Rowan, RN, MS and Pol-Henri Guivarc'h, MD

From the National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Maryland (Dr Dionne, Dr Brahim, Ms Rowan); Pharma-Logic, Miami, Florida (Dr Haynes); and SkyePharma Canada, Quebec, Canada (Dr Guivarc'h).

Nonsteroidal anti-inflammatory drugs produce their analgesic and adverse effects through interaction with cyclooxygenase in a variety of tissues. The authors evaluated the therapeutic potential of administering a sustained-release formulation of flurbiprofen into a surgical wound following oral surgery to produce analgesia at the site of injury while minimizing exposure to potential targets for toxicity. Subjects (N = 98) received 1 of 8 treatments: flurbiprofen in a microparticle formulation in doses of 3.125 mg, 6.25 mg, 12.5 mg, 25 mg, or 50 mg; PO flurbiprofen 25 mg or 50 mg; or placebo. The flurbiprofen microparticle formulation or matching placebo was placed into the extraction sites at the end of surgery (removal of 2 lower impacted third molars). The sum of the pain visual analog scale over the 6-hour observation period demonstrated significantly less pain (P < .05) for flurbiprofen microparticle in comparison with placebo. Fewer subjects remedicated in the flurbiprofen microparticle drug groups, primarily for the 12.5-mg and higher doses. The incidence of adverse effects and local complications did not differ across groups. These data suggest that direct administration of flurbiprofen in a microparticle formulation at a site of tissue injury delays the onset and lowers the intensity of postoperative pain at lower doses than usually administered orally.

Key Words: Nonsteroidal anti-inflammatory drugs • flurbiprofen • analgesia • postoperative pain

Address for reprints: Raymond A. Dionne, DDS, PhD, NIDCR, NIH, 10 Center Drive, 1N-103, Bethesda, MD 20892-1197.


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