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Abstract

Aim: To evaluate safety and efficacy of diclofenac 75 mg/1ml (Dynapar AQ) administered as IV bolus versus diclofenac 75mg/3ml administered as IV infusion in patients with postoperative pain. Methods: 350 postoperative adult patients were randomized to receive either treatment. Primary efficacy endpoints were time to onset of analgesia and postoperative pain intensity while secondary efficacy endpoints included degree of pain relief and global assessment by patient and investigator. The safety endpoints were pain intensity and grade of thrombophlebitis at injection site. Safety and efficacy endpoints were evaluated over 12 hour study period. Results: Both study drugs were safe and effective throughout study period. However, IV bolus route of Dynapar AQ produced significantly faster onset of analgesia, better improvement in postoperative pain intensity and pain relief upto 1 hour, lesser thrombophlebitis and lesser pain at administration site upto 8 hours. Also, global assessment by patient and investigator was significantly favorable towards Dynapar AQ. Conclusions: IV bolus route of Dynapar AQ is better alternative to IV infusion of diclofenac 75mg/3ml with rapid onset of analgesia and better tolerability at injection site.