Phase III, randomized, double-blind, placebo-controlled trial of topical 2 % lidocaine for the prevention and treatment of oral mucosal pain in children.

OBJECTIVES: The aim of this study was to assess the efficacy in pain reduction of topical 2 % lidocaine compared to a placebo cream in children with oral mucosal lesions due to trauma or aphthous ulcers or in the prevention of clamp placement pain.

MATERIALS AND METHODS: The design was a double-blind, randomized, placebo-controlled, four-center trial on 64 patients. Pain intensity and relief were measured using a 100-mm visual analog scale (VAS). One-tailed Student's t test and ANOVA were used for statistical analyses.

RESULTS: Independent of the pain origin, application of 2 % lidocaine cream led to a mean reduction in VAS pain intensity of 19.7 mm ± 18.3, which was significantly greater than that obtained with the placebo cream (p = .025). Analyses showed a statistically significant efficacy of the 2 % lidocaine cream (p < .0001). Its efficacy was not associated to any local or systemic adverse drug reaction, as reported by the patients. As the most important population represented in our patients was children whom a rubber dam clamp was placed, we also specifically analysed this population, and we were able to demonstrate a significantly greater efficacy of the 2 % lidocaine cream on the pain caused by the rubber dam clamp placement in comparison to the placebo cream (p < .005).

CONCLUSIONS: A significant reduction in pain intensity occurred after application of 2 % lidocaine cream, and the effect was significantly greater than that obtained with the placebo cream. Considering the study's limitations, this product appears safe for use in children.

CLINICAL RELEVANCE: For painful benign lesions of the oral mucosa (trauma or aphthous ulcers) or for preventing painful iatrogenic procedures such as rubber dam clamp placement, it is essential to treat or prevent pain onset, especially in the pediatric population for whom a painful experience could end in refusal of dental care. Application of a topical anesthetic in this specific situation is of particular interest, as is defining its efficacy and safety.