PURPOSE: The purpose of this study was to compare the effectiveness of midazolam (MDZ) alone to a combination of MDZ and hydroxyzine (MDZH) when sedating young children for dental treatment. METHODS: This was a prospective, double-blinded, crossover clinical study of young uncooperative children in need of at least 2 restorative visits. Twenty-eight children, ages 21 to 56 months, with a mean age of 36.6 months, participated in this study. The subjects were assigned randomly to receive either 0.5 mg/kg of oral MDZ 20 minutes prior to the beginning of dental treatment or the combination of 0.3 mg/kg oral MDZ with 3.7 mg/kg of hydroxyzine 30 minutes before treatment. The alternative drug regimen was administered at the second appointment. All subjects also received 50% nitrous oxide and were restrained with a papoose board. The child's behavior (quiet or crying, relaxed or moving) was evaluated every 5 minutes by an experienced pediatric dentist who was unaware of the drug given to the child. At the conclusion of treatment, each session was evaluated for overall effectiveness. RESULTS: Regardless of the type of premedication, more patients exhibited quiet behavior at the beginning of treatment, with an increase in crying and movement toward the end of treatment. Regarding movement, a significant difference was observed during the first 20 minutes between the 2 regimens. MDZ showed more children exhibiting movement. During the first 30 minutes of treatment, more children cried in the MDZ group, while MDZH presented more children asleep or quiet. No significant differences were found in behavior as a function of the order the sedative regimens were given. No significant differences between the 2 regimens regarding overall behavior and success (t=0.655 at 27 degrees of freedom; P=.518) were found. CONCLUSIONS: The combination of hydroxyzine (3.7 mg/kg) with MDZ (0.3 mg/kg) administered 30 minutes before treatment resulted in safe and effective sedation for the dental treatment of young children. This combination's use might be more advantageous when compared to MDZ alone, resulting in less crying and movement during the first 30 and 20 minutes, respectively.
RCT Entities:
PURPOSE: The purpose of this study was to compare the effectiveness of midazolam (MDZ) alone to a combination of MDZ and hydroxyzine (MDZH) when sedating young children for dental treatment. METHODS: This was a prospective, double-blinded, crossover clinical study of young uncooperative children in need of at least 2 restorative visits. Twenty-eight children, ages 21 to 56 months, with a mean age of 36.6 months, participated in this study. The subjects were assigned randomly to receive either 0.5 mg/kg of oral MDZ 20 minutes prior to the beginning of dental treatment or the combination of 0.3 mg/kg oral MDZ with 3.7 mg/kg of hydroxyzine 30 minutes before treatment. The alternative drug regimen was administered at the second appointment. All subjects also received 50% nitrous oxide and were restrained with a papoose board. The child's behavior (quiet or crying, relaxed or moving) was evaluated every 5 minutes by an experienced pediatric dentist who was unaware of the drug given to the child. At the conclusion of treatment, each session was evaluated for overall effectiveness. RESULTS: Regardless of the type of premedication, more patients exhibited quiet behavior at the beginning of treatment, with an increase in crying and movement toward the end of treatment. Regarding movement, a significant difference was observed during the first 20 minutes between the 2 regimens. MDZ showed more children exhibiting movement. During the first 30 minutes of treatment, more children cried in the MDZ group, while MDZH presented more children asleep or quiet. No significant differences were found in behavior as a function of the order the sedative regimens were given. No significant differences between the 2 regimens regarding overall behavior and success (t=0.655 at 27 degrees of freedom; P=.518) were found. CONCLUSIONS: The combination of hydroxyzine (3.7 mg/kg) with MDZ (0.3 mg/kg) administered 30 minutes before treatment resulted in safe and effective sedation for the dental treatment of young children. This combination's use might be more advantageous when compared to MDZ alone, resulting in less crying and movement during the first 30 and 20 minutes, respectively.