Sustained relief of oral aphthous ulcer pain from topical diclofenac in hyaluronan: a randomized, double-blind clinical trial.
OBJECTIVE
The purpose of this study was to test the hypothesis that topically applied 3% diclofenac in 2.5% hyaluronan reduces aphthous ulcer pain.


METHODS
A randomized, double-blind, single dose study of 60 healthy adults with aphthous ulcers in three treatment groups--3% diclofenac in 2.5% hyaluronan, 2.5% hyaluronan, 3% viscous lidocaine--was undertaken. Visual analogue scale pain scores were obtained before and after gel application and hourly, for up to 8 hours after gel application. Statistical analysis was performed with repeated measures ANOVA with square root transformation and Bonferroni correction.


RESULTS
A 48% overall reduction in pain (p < 0.01) was observed 10 minutes after gel application; however, no significant difference was found between the three topical agents. A 35% to 52% pain reduction (p < 0.01) was reported 2 to 6 hours after the application of diclofenac in hyaluronan, whereas hyaluronan gel alone and viscous lidocaine failed to produce significant VAS reductions.


CONCLUSIONS
A dose of 3% diclofenac in 2.5% hyaluronan is an effective and novel treatment for this common, painful disorder.
Saxen
M A
MA
Department of Oral Surgery, Medicine and Pathology, Indiana University School of Dentistry, Indianapolis, Ind., USA.
Ambrosius
W T
WT
Rehemtula al-KF
Russell
A L
AL
Eckert
G J
GJ
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage / Q000627:therapeutic use*; D000704:Analysis of Variance; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004008:Diclofenac / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D008012:Lidocaine / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D013281:Stomatitis, Aphthous / Q000188:drug therapy*
D000700:Analgesics; D000779:Anesthetics, Local; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D004008:Diclofenac; D006820:Hyaluronic Acid; D008012:Lidocaine