OBJECTIVES:Ametop gel (4% amethocaine) is a relatively new topical anesthetic that produces anesthesia within 30 to 45 minutes and therefore may be appropriate for use in busy outpatient settings. The objective of this study was to assess the efficacy and safety of 4% amethocaine in reducing the pain of subcutaneous measles-mumps-rubella vaccination in 1-year-old infants. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in pediatric outpatient clinics. RESULTS: A total of 120 infants participated in the study; 60 were followed up for assessment of antibody titers after 1 month. Either 1 g of amethocaine or placebo was applied for 30 minutes before vaccination. The Modified Behavioral Pain Scale was used to assess pain; the mean (standard deviation) pain scores for the amethocaine group (n = 61) was 1.5 (1.6) versus 2.3 (2.2) for the placebo group (n = 59). The rate of vaccination success (88% and 87%) was not different between treatment groups. CONCLUSIONS: 4% Amethocaine significantly reduces the pain of measles-mumps-rubella vaccination in infants when compared with placebo and does not seem to interfere with subsequent development of protective antibody levels. Because of its relatively short application time (30 minutes), 4% amethocaine may be suitable for busy clinics and emergency departments.
RCT Entities:
OBJECTIVES:Ametop gel (4% amethocaine) is a relatively new topical anesthetic that produces anesthesia within 30 to 45 minutes and therefore may be appropriate for use in busy outpatient settings. The objective of this study was to assess the efficacy and safety of 4% amethocaine in reducing the pain of subcutaneous measles-mumps-rubella vaccination in 1-year-old infants. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in pediatric outpatient clinics. RESULTS: A total of 120 infants participated in the study; 60 were followed up for assessment of antibody titers after 1 month. Either 1 g of amethocaine or placebo was applied for 30 minutes before vaccination. The Modified Behavioral Pain Scale was used to assess pain; the mean (standard deviation) pain scores for the amethocaine group (n = 61) was 1.5 (1.6) versus 2.3 (2.2) for the placebo group (n = 59). The rate of vaccination success (88% and 87%) was not different between treatment groups. CONCLUSIONS: 4% Amethocaine significantly reduces the pain of measles-mumps-rubella vaccination in infants when compared with placebo and does not seem to interfere with subsequent development of protective antibody levels. Because of its relatively short application time (30 minutes), 4% amethocaine may be suitable for busy clinics and emergency departments.