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.
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.
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.
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.