Abstract

e12 Volume 35 Number 8S Introduction: Oral or intravenous (IV) paracetamol (APAP) is used for mild to moderate pain but has a latency to be effective. When fast relief is required and oral/IV routes are not available because of the patient’s condition, the transmucosal buccal route may be an alternative. A new transmucosal buccal (b) pharmaceutical form of APAP that had been previously assessed in healthy volunteers is studied in patients admitted to hospital for acute pain. Patients (or Materials) and Methods: A randomized doubleblind noninferiority clinical trial (NCT01586143) included 38 patients admitted to the Accident and Emergency Department of Clermont-Fd University Hospital, France, for trauma of the upper or lower limb, and with pain intensity between 4 and 6 on a 0 to 10 numerical scale (NS). Patients were injected at t0 over a 15-minute period with placebo (0.9% saline) or APAP (1 g) and concomitantly, 125 mg of APAP dissolved in 1 mL of an hydroalcoholic solution (HAS) or placebo (HAS only) was applied in the left mucogingival sulcus. Patients were asked not to swallow for 1:30 minutes. NS evaluations were done at t10, t30, t120, and t180 minutes after administration. Primary end point was the pain intensity difference (PID) between t30 min and t0. PID of both arms were compared by Student t test with a P 0.05). Conclusion: Transmucosal buccal APAP has a similar analgesic effect than ivAPAP in patients admitted to hospital for acute trauma pain of mild to moderate intensity. The mechanism of action of this pharmaceutical form must now be studied further. This attractive alternative to other routes would be useful in situations where oral or IV routes are not available or in vulnerable populations (cancer pain, palliative care, geriatrics) for acute pain paroxysms. Disclosure of Interest: None declared.

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