Abstract
OBJECTIVE A randomized study comparing efficacy and safety of a new 75 mg/1 ml formulation of injectable diclofenac sodium designed for intra-deltoid use with the conventional 75 mg/3 ml formulation given by the intra-gluteal route. DESIGN This was an open-label, multicentric, randomized clinical trial. METHODS A total of 250 adult patients with post-operative pain were randomized to receive either an injection diclofenac 75 mg/1 ml or diclofenac 75 mg/3 ml. Primary efficacy criteria were time to onset of analgesia and reduction in pain intensity. Severity of pain at site of injection and side effects were also evaluated. RESULTS 232 patients completed the study. The mean times to onset of anal-gesia were comparable (16.17 ± 12.70 min in the diclofenac 75 mg/1 ml group and 19.16 ± 11.79 min in the diclofenac 75 mg/3 ml group). However, significantly more patients achieved analgesia in less than 5 min and had less pain at the site of injection with the 1 ml formulation. The need for rescue medication was also lower with the 1 ml formulation (2.5% vs. 9.82%). No side effects were reported. A significantly larger number of patients and physicians rated the efficacy and safety of injectable diclo-fenac 75 mg/1 ml as excellent. CONCLUSION Both formulations were effective and safe in the management of post-operative pain with a significantly lower need for rescue analgesia and less pain at site of injection with diclofenac 75 mg/1 ml formulation. The 1 ml formulation had an added advantage of intra-deltoid use. This would be specially helpful in obese/overweight patients with a thick subcutaneous pad of fat over the gluteal region.
