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Int J Clin Pharmacol Ther. 2011 Apr;49(4):286-90. doi: 10.5414/CP201512.

Clinical efficacy of a novel new injectable diclofenac formulation designed for intradeltoid use in post-operative pain management.

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1
Department of Anaesthesia, Seth G.S. Medical college and KEM Hospital, Mumbai, India.

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.

PMID:
21429443
[Indexed for MEDLINE]

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