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3039083 
Journal Article 
Diclofenac sodium injection (Dyloject (R)) - In postoperative pain 
Mccormack, PL; Scott, LJ 
2008 
Yes 
Drugs
ISSN: 0012-6667
EISSN: 1179-1950 
Adis International Ltd 
68 
1 
123-130 
English 
18081376 
WOS:000252669800008 
A new formulation of the nonselective NSAID diclofenac sodium suitable for intravenous bolus injection has been developed using hydroxypropyl beta-cyclodextrin as a solubility enhancer (HP beta CD diclofenac). HP beta CD diclofenac intravenous bolus injection was shown to be bioequivalent to the existing parenteral formulation of diclofenac containing propylene glycol and benzyl alcohol as solubilizers (PG-BA diclofenac), which is relatively insoluble and requires slow intravenous infusion over 30 minutes. Single-dose HP beta CD diclofenac 3.75, 9.4, 18.75, 25, 37.5, 50 and 75 mg administered by intravenous bolus injection produced significantly greater responses than placebo for total pain relief (TOTPAR) over 6 hours or pain intensity at 4 hours in the treatment of moderate or severe postoperative dental pain in randomized, double-blind trials. HP beta CD diclofenac 37.5 and 75 mg were similar in efficacy to intravenous bolus ketorolac 30 mg. In a well controlled trial, single-dose HP beta CD diclofenac 75 mg intravenous bolus injection was shown to be superior to PG-BA diclofenac 75 mg intravenous infusion with respect to TOTPAR over 4 hours, indicating faster onset of analgesia in the treatment of moderate or severe postoperative dental pain. Both HP beta CD diclofenac and PG-BA diclofenac were superior to placebo. HP beta CD diclofenac was generally well tolerated during single-dose treatment of postoperative pain. The tolerability profile was similar to that of PG-BA diclofenac, but with a lower incidence of thrombophlebitis. 
Adis Drug Profiles; Diclofenac, general; Postoperative pain