Efficacy of Topical 1% Lidocaine in the Symptomatic Treatment of Pain Associated With Oral Mucosal Trauma or Minor Oral Aphthous Ulcer: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Study

Aims: To determine the efficacy in pain reduction of a topical 1% lidocaine compared to a placebo cream in patients with oral mucosal lesions due to trauma or minor oral aphthous ulcer. Methods: The design was a double-blind, randomized, placebo-controlled, sixcenter trial on 59 patients. Pain intensity and relief were measured using a 100-mm visual analog scale (VAS). One-tailed Student t test and ANOVA analyses were used for statistical analyses. Results: Independent of the pain origin (oral mucosal trauma or minor oral aphthous ulcer), the application of the 1% lidocaine cream led to a mean reduction in VAS pain intensity of 29.4 mm ± 17.0, which was significantly greater than the decrease obtained with the placebo cream. Analysis showed a statistically significant efficacy of the 1% lidocaine cream (P = .0003). Its efficacy was not related to the type of lesion, and no adverse drug reaction, either local or systemic, was reported by any of the patients. Conclusion: A significant reduction in pain intensity occurred after application of 1% lidocaine cream and was significantly greater than that with the placebo cream. Taking into account the study’s limitations, this product seems safe to use.

acute pain;aphthous;lidocaine;mucosal trauma;topical

1. Scully C, Field EA, Randall C. Over-the-counter remedies for oral soreness. Periodontol 2000 2008;48:76–84.

2. Porter SR, Leao JC. Review article: Oral ulcers and its relevance to systemic disorders. Aliment Pharmacol Ther 2005; 21:295–306.

3. Scully C, Felix DH. Oral medicine–Update for the dental practitioner. Aphthous and other common ulcers. Br Dent J 2005;199:259–264.

4. Scully C. Clinical practice. Aphthous ulceration. N Engl J Med 2006;355:165–172.

5. Burgess JA, van der Ven PF, Martin M, Sherman J, Haley J. Review of over-the-counter treatments for aphthous ulceration and results from use of a dissolving oral patch containing glycyrrhiza complex herbal extract. J Contemp Dent Pract 2008;9:88–98.

6. Rosa AL, Sverzut CE, Xavier SP, Lavrador MA. Clinical effectiveness of lidocaine and benzocaine for topical anesthesia. Anesth Prog 1999;46:97–99.

7. Meechan JG. Intraoral topical anesthesia. Periodontol 2000 2008;46:56–79.

8. Lidocaine in Martindale: The Complete Drug Reference, ed 34. London: Pharmaceutical Press, 2005:1377–1381.

9. Lidocaine in The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, ed 13. Whitehouse Station, NJ: Merck, 2001:982.

10. Kravitz ND. The use of compound topical anesthetics: A review. J Am Dent Assoc 2007;138:1333–1339.

11. Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia 1976;31:1191–1198.

12. McCormack HM, Horne DJL, Sheather S. Clinical applications of visual analogue scales: A critical review. Psycholog Med 1988;18:1007–1019.

13. Breivik H, Borchgrevink PC, Allen SM, et al. Assessment of pain. Br J Anaesth 2008;101:17–24.

14. Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med 1996;27:485–489.

15. Finniss DG, Kaptchuk TJ, Miller F, Benedetti F. Biological, clinical, and ethical advances of placebo effects. Lancet 2010;375:686–695.

16. Huang HW, Wang WC, Lin CC. Influence of age on thermal thresholds, thermal pain thresholds, and reaction time. J Clin Neurosci 2010;17:722–726.

17. Lautenbacher S, Kunz M, Strate P, Nielsen J, Arendt-Nielsen L. Age effects on pain thresholds, temporal summation and spatial summation of heat and pressure pain. Pain 2005; 115:410–418.

18. Cannell H. Evidence for safety margins of lignocaine local anaesthetics for peri-oral use. Br Dent J 1996;181:243–249.

19. Kasaj A, Heib A, Willershausen B. Effectiveness of a topical salve (Dynexan) on pain sensitivity and early wound healing following nonsurgical periodontal therapy. Eur J Med Res 2007;12:196–199.