Isabelita Duarte Azevedo1, Maria Angela Fernandes Ferreira2, Anna Paula Serejo da Costa3, Vera Lúcia Bosco4, Rachel Duarte Moritz5. 1. Department of Pediatric Dentistry, School of Dentistry, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. 2. Department of Public Health, School of Dentistry, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. 3. Department of Public Health, School of Dentistry, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. ninha_serejo@hotmail.com. 4. Department of Pediatric Dentistry, School of Dentistry, at the Federal University of Santa Catarina, Florianopolis, Santa Catarina, Brazil. 5. Department of Internal Medicine, School of Medicine, at the Federal University of Santa Catarina, Florianopolis, Santa Catarina, Brazil.
Abstract
PURPOSE: Pharmacological management of uncooperative children is becoming increasingly common in the dental setting. The purpose of this study was to determine the efficacy and safety of 3 different doses of midazolam for sedation in 2- to 4- year-old children with multiple dental needs and negative behavior. METHODS: Ten children participated in this crossover, controlled, double-blinded clinical trial, which evaluated their behavior, appointment length and patient response after administration of 3 different doses of midazolam or placebo. Oxygen saturation, heart rate, respiratory rate, and blood pressure were monitored in all sessions. RESULTS: Sedated children exhibited a more positive behavior compared to the placebo group, both at the beginning of the appointment (sitting in the chair) and during administration of local anesthesia (P=.008 and P<.03, respectively). The use of midazolam allowed for longer appointments, and doses of at least 0.3 mg/kg produced a higher rate of positive behavior overall. No changes in oxygen saturation, heart rate, respiratory rate, and blood pressure were observed. CONCLUSION:Midazolam was effective and safe for pediatric sedation in the dosages studied.
RCT Entities:
PURPOSE: Pharmacological management of uncooperative children is becoming increasingly common in the dental setting. The purpose of this study was to determine the efficacy and safety of 3 different doses of midazolam for sedation in 2- to 4- year-old children with multiple dental needs and negative behavior. METHODS: Ten children participated in this crossover, controlled, double-blinded clinical trial, which evaluated their behavior, appointment length and patient response after administration of 3 different doses of midazolam or placebo. Oxygen saturation, heart rate, respiratory rate, and blood pressure were monitored in all sessions. RESULTS: Sedated children exhibited a more positive behavior compared to the placebo group, both at the beginning of the appointment (sitting in the chair) and during administration of local anesthesia (P=.008 and P<.03, respectively). The use of midazolam allowed for longer appointments, and doses of at least 0.3 mg/kg produced a higher rate of positive behavior overall. No changes in oxygen saturation, heart rate, respiratory rate, and blood pressure were observed. CONCLUSION:Midazolam was effective and safe for pediatric sedation in the dosages studied.