S F Malamed1, S Gagnon, D Leblanc. 1. School of Dentistry, University of Southern California, USA. malamed@hsc.usc.edu
Abstract
PURPOSE: Three identical single-dose, randomized, double-blind, parallel-group, active-controlled multicenter studies were conducted to compare the safety and efficacy of articaine HCl (4% with epinephrine 1:100,000) to that of lidocaine HCl (2% with epinephrine 1:100,000) in patients aged 4 years to 79 years, with subgroup analysis on subjects 4 to < 13 years. METHODS:Fifty subjects under the age of 13 years were treated in the articainegroup and 20 subjects under the age of 13 were treated withlidocaine. Subjects were randomized in a 2:1 ratio to receive articaine or lidocaine. Efficacy was determined on a gross scale immediately following the procedure by having both the subject and investigator rate the pain experienced by the subject during the procedure using a visual analog scale (VAS). Safety was evaluated by measuring vital signs before and after administration of anesthetic (1 and 5 minutes post-medication and at the end of the procedure) and by assessing adverse events throughout the study. Adverse events were elicited during telephone follow-up at 24 hours and 7 days after the procedure. RESULTS: Pediatric patients received equal volumes, but higher mg/kg doses, of articaine than lidocaine during both simple and complex dental procedures. Pain ratings: Articaine: VAS (Visual Analogue Scale) scores (from 0 to 10 cm) by patients 4 to < 13 years of age were 0.5 for simple procedures and 1.1 for complex procedures, and average investigator scores were 0.4 and 0.6 for simple and complex procedures, respectively. Lidocaine: patients 0.7 (simple) and 2.3 (complex); investigators 0.3 (simple) and 2.8 (complex). Adverse events: No serious adverse events related to the articaine occurred. The only adverse event considered related to articaine was accidental lip injury in one patient. CONCLUSIONS:VAS scores indicate that articaine is an effective local anesthetic in children and that articaine is as effective as lidocaine when measured on this gross scale. Articaine 4% with epinephrine 1:100,000 is a safe and effective local anesthetic for use in pediatric dentistry. Time to onset and duration of anesthesia are appropriate for clinical use and are comparable to those observed for other commercially available local anesthetics.
RCT Entities:
PURPOSE: Three identical single-dose, randomized, double-blind, parallel-group, active-controlled multicenter studies were conducted to compare the safety and efficacy of articaine HCl (4% with epinephrine 1:100,000) to that of lidocaine HCl (2% with epinephrine 1:100,000) in patients aged 4 years to 79 years, with subgroup analysis on subjects 4 to < 13 years. METHODS: Fifty subjects under the age of 13 years were treated in the articaine group and 20 subjects under the age of 13 were treated with lidocaine. Subjects were randomized in a 2:1 ratio to receive articaine or lidocaine. Efficacy was determined on a gross scale immediately following the procedure by having both the subject and investigator rate the pain experienced by the subject during the procedure using a visual analog scale (VAS). Safety was evaluated by measuring vital signs before and after administration of anesthetic (1 and 5 minutes post-medication and at the end of the procedure) and by assessing adverse events throughout the study. Adverse events were elicited during telephone follow-up at 24 hours and 7 days after the procedure. RESULTS: Pediatric patients received equal volumes, but higher mg/kg doses, of articaine than lidocaine during both simple and complex dental procedures. Pain ratings: Articaine: VAS (Visual Analogue Scale) scores (from 0 to 10 cm) by patients 4 to < 13 years of age were 0.5 for simple procedures and 1.1 for complex procedures, and average investigator scores were 0.4 and 0.6 for simple and complex procedures, respectively. Lidocaine: patients 0.7 (simple) and 2.3 (complex); investigators 0.3 (simple) and 2.8 (complex). Adverse events: No serious adverse events related to the articaine occurred. The only adverse event considered related to articaine was accidental lip injury in one patient. CONCLUSIONS: VAS scores indicate that articaine is an effective local anesthetic in children and that articaine is as effective as lidocaine when measured on this gross scale. Articaine 4% with epinephrine 1:100,000 is a safe and effective local anesthetic for use in pediatric dentistry. Time to onset and duration of anesthesia are appropriate for clinical use and are comparable to those observed for other commercially available local anesthetics.
Authors: Yangjie Wei; Michael P Nedley; Sarit B Bhaduri; Xavier Bredzinski; Sai H S Boddu Journal: AAPS PharmSciTech Date: 2014-11-01 Impact factor: 3.246