D C Sullivan1, C F Wilson, M D Webb. 1. Baylor College of Dentistry, Texas A&M University System Health Science Center, Dallas, Texas, USA.
Abstract
PURPOSE: This study compared 2 oral ketamine-diazepam regimens (8 mg/kg and 10 mg/kg of ketamine in combination with 0.1 mg/kg diazepam) in preschool age children with respect to physiological, behavioral and amnestic parameters. METHODS:Twenty-five children completed the double-blind, crossover design. Physiologic, behavioral and amnestic effects were evaluated. RESULTS: ANOVA demonstrated significant changes in systolic blood pressures and heart rates in both the 8 mg/kg group and 10 mg/kg group (P < 0.05), as well as significant changes in diastolic blood pressures in the 10 mg/kg group (P < 0.05). However, these changes were not clinically significant. Success rates were 28% for the 8 mg/kg dosage and 44% for the 10 mg/kg dosage. There was a cumulative vomiting rate of 50% and a psychic phenomena rate of 10%. There were no statistically significant differences between the two dosages with regard to success rates, postoperative vomiting, or psychic phenomena using McNemar's test. CONCLUSIONS: There is no advantage of 10 mg/kg dose of ketamine over the 8 mg/kg dose. Ketamine did not demonstrate amnestic effects in this study. There were statistically but no clinically significant changes in physiological parameters in either group. This study does not support the use of either 8 mg/kg or 10 mg/kg oral ketamine for the sedation of uncooperative children.
RCT Entities:
PURPOSE: This study compared 2 oral ketamine-diazepam regimens (8 mg/kg and 10 mg/kg of ketamine in combination with 0.1 mg/kg diazepam) in preschool age children with respect to physiological, behavioral and amnestic parameters. METHODS: Twenty-five children completed the double-blind, crossover design. Physiologic, behavioral and amnestic effects were evaluated. RESULTS: ANOVA demonstrated significant changes in systolic blood pressures and heart rates in both the 8 mg/kg group and 10 mg/kg group (P < 0.05), as well as significant changes in diastolic blood pressures in the 10 mg/kg group (P < 0.05). However, these changes were not clinically significant. Success rates were 28% for the 8 mg/kg dosage and 44% for the 10 mg/kg dosage. There was a cumulative vomiting rate of 50% and a psychic phenomena rate of 10%. There were no statistically significant differences between the two dosages with regard to success rates, postoperative vomiting, or psychic phenomena using McNemar's test. CONCLUSIONS: There is no advantage of 10 mg/kg dose of ketamine over the 8 mg/kg dose. Ketamine did not demonstrate amnestic effects in this study. There were statistically but no clinically significant changes in physiological parameters in either group. This study does not support the use of either 8 mg/kg or 10 mg/kg oral ketamine for the sedation of uncooperative children.