title: Phase III, randomized, double-blind, placebo-controlled trial of topical 2 % lidocaine for the prevention and treatment of oral mucosal pain in children.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: INSERM, UMR 872, Cordeliers Research Center, Team 5, Laboratory of Oral Molecular Physiopathology, Universities Paris Diderot, Paris 7, Pierre and Marie Curie and Paris-Descartes, Paris, 75006, France.
authors.forename: Amélie E
authors.initials: AE
authors.lastname: Coudert
authors.affiliation: INSERM UMR-S 606, Hôpital Lariboisière, Ambroise Paré Street, 75010, Paris, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Ostertag
authors.affiliation: INSERM, UMR 872, Cordeliers Research Center, Team 5, Laboratory of Oral Molecular Physiopathology, Universities Paris Diderot, Paris 7, Pierre and Marie Curie and Paris-Descartes, Paris, 75006, France.|Oral Surgery Department, Pitié-Salpêtrière University Hospital, Paris Diderot University, Paris, France.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Baaroun
authors.affiliation: , 1 Rue Pixérécourt, 75020, Paris, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Artaud
authors.affiliation: , 62 Rue Saint-Didier, 75116, Paris, France.
authors.forename: Chantal
authors.initials: C
authors.lastname: Ifi-Naulin
authors.affiliation: , 9, Rue Eugene Manuel, 75116, Paris, France.
authors.forename: Jean-Patick
authors.initials: JP
authors.lastname: Druo
authors.affiliation: Groupe Hospitalier Paris Saint Joseph, 185 rue Raymond Losserand, 75014, Paris, France.
authors.forename: Guy
authors.initials: G
authors.lastname: Princ
authors.affiliation: INSERM, UMR 872, Cordeliers Research Center, Team 5, Laboratory of Oral Molecular Physiopathology, Universities Paris Diderot, Paris 7, Pierre and Marie Curie and Paris-Descartes, Paris, 75006, France. vdescroix@gmail.com.|Oral Surgery Department, Pitié-Salpêtrière University Hospital, Paris Diderot University, Paris, France. vdescroix@gmail.com.
authors.forename: Vianney
authors.initials: V
authors.lastname: Descroix
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009061:Mouth Mucosa / Q000473:pathology*; D010146:Pain / Q000188:drug therapy* / Q000517:prevention & control*; D010147:Pain Measurement
chemical_list: D000779:Anesthetics, Local; D008012:Lidocaine
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