ABSTRACT. Use of firocoxib in dogs for postoperative pain control has not been published in any of the journals in Japan. A field study was conducted to evaluate the efficacy and safety of firocoxib in dogs in controlling pain associated with soft tissue surgery in Japan. The study followed a negative control, double-blind, multicenter clinical efficacy study using a randomized block design. A total of 131 client-owned dogs presented to the clinical practices for soft tissue surgery were enrolled. Sixty-nine dogs were allocated to the firocoxib-treated group and received 5 mg/kg of firocoxib orally on Day 0 before the surgery and once daily through Day 2, while 62 dogs were allocated to the non-treated group handled in a similar manner only without the firocoxib administration. Pain assessment took place on Day 0 before the surgery through Day 2. The primary efficacy variable was a success/failure variable based on whether the dog needed rescue medication (based on pain assessment after the surgery or Investigator's judgment) and a significant difference between firocoxib-treated group (16.4%) and non-treated group (50.0%) (P=0.0031) was observed. There was no adverse event during the study that was considered to be related to the administration of firocoxib. This study indicated the clinical efficacy and safety profile of firocoxib administered to control pain associated with soft tissue surgery under field condition.

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