Evaluation of the effectiveness and safety of a new formulation of Injection Diclofenac DYNAPAR AQ (75mg/ml) in the management of post operative pain: A pilot study

B.M. Subnis, P. Patel, C.V. Pradhan, P.N. Kakar, K. Varma, V. Jaiswal
Indian Medical Gazette- June 2010: 213-217

 

ABSTRACT

 

Introduction

DYNAPAR AQ, a new formulation of diclofenac sodium suitable for intra-deltoid injection was developed. The aim of the study was to evaluate the efficacy and safety of intra-deltoid DYNAPAR AQ in the management of post operative pain.

 

Methods

191 adult patients with post operative pain [VAS (Visual Analogue Scale) greater than or equal to 7] received a single dose of DYNAPAR AQ injected intradeltoid. Primary efficacy criteria were time to onset of analgesia and reduction in pain intensity. Pain intensity was recorded at 1, 4, 8 and 12 hours. Severity of pain at site of injection was recorded at 1 and 12 hours.

 

Results

Following administration of DYNAPAR AQ mean pain intensity fell significantly by 37.6, 56.5, 61.0 and 62.8 percentage at the end of 1, 4, 8 and 12 hours respectively (p less than 0.05 for all time points as compared to baseline). Mean time taken for onset of analgesia was 20.37 plus or minus 10.22 minutes. 18 of the 191 patients needed rescue analgesia. Most patients experienced either no pain or mild pain at site of injection. There was no report of severe pain.

 

Conclusion

Intra-deltoid DYNAPAR AQ appears to be efficacious and well tolerated in the management of post operative pain. This would especially be helpful in the management of patients with thick subcutaneous fat in the gluteal region.