RESUMEN
To evaluate the efficacy and safety of a fixed dose combination of diclofenac sodium and acetaminophen injection a study was carried out in patients suffering from acute pain. Thirty-eight adult patients undergoing orthopaedic surgery received 3ml injection of diclofenac 25mg and acetaminophen 75mg per ml by deep intramuscular route 8 hourly for 6 doses. The pain assessment was made on a 1-100 mm visual analogue scale (VAS), onset of action, extent of pain relief and maximum fall in VAS score after the first dose was assessed. Injection pentazocine lactate was administered as rescue medication in case of uncontrolled pain. At baseline the pain score on VAS was 78.55 +/- 17.12, which at the end of 1 hour was found to be 43.57 +/- 19.91. There was a statistically significant (p<0.0001, ANOVA) reduction in mean pain score starting from 15 minutes after administration of first dose and extending up to the end of study period. Complete relief was seen in 17 patients (44.74%) and the mean time for complete relief was 172.20 minutes after the first dose. Maximum fall and maximum percentage fall in VAS score during the study period was 71.71 mm and 92.76% respectively on a 0-100 mm VAS, and the time for achieving maximum fall was 172.50 minutes after the first dose of study medication. The results of this study suggest that fixed dose combination of diclofenac and acetaminophen is effective and safe for management of postoperative pain in orthopaedic surgery.