PURPOSE: The purpose was to evaluate two sedation protocols during dental sessions in anxious children. MATERIALS AND METHODS: It was a randomized and double-blind study, with each individual being his/her own control within each protocol. Furthermore, the two protocols were compared. Twenty children (36 to 84 months old) who exhibited "definitely negative" behavior according to the Frankl scale were assigned to receive oral chloral hydrate (40 mg/kg) (Group I) or Diazepam (5 mg) (Group II). Behavior during local anesthesia, application of rubber dam, cavity preparation, restorative procedures was evaluated, considering the degree of sleep, body movement, crying and overall behavior. Vital signs were assessed at three different times. The Wilcoxon, Mann-Whitney, Exact Fisher's and Spearman correlation tests were used to analyze the data. RESULTS: Group I presented higher scores for sleep during the CH session than placebo session during rubber dam application (P = 0.0431) and restoration (P = 0.0431). In Group II there was no statistically significant difference (p > 0.05). There were no statistically significant differences between sessions and groups in the evaluation of body movement, crying and vital signs. Overall behavior in the placebo session was better than in the CH session during local anesthesia, but there was no difference between the two drug regimens. There was influence of age during anesthesia and cavity preparation in Group I and during rubber dam application in Group II. It was concluded that oral diazepam and chloral hydrate had no influence on the behavior management for dental treatment with the studied sample.
RCT Entities:
PURPOSE: The purpose was to evaluate two sedation protocols during dental sessions in anxious children. MATERIALS AND METHODS: It was a randomized and double-blind study, with each individual being his/her own control within each protocol. Furthermore, the two protocols were compared. Twenty children (36 to 84 months old) who exhibited "definitely negative" behavior according to the Frankl scale were assigned to receive oral chloral hydrate (40 mg/kg) (Group I) or Diazepam (5 mg) (Group II). Behavior during local anesthesia, application of rubber dam, cavity preparation, restorative procedures was evaluated, considering the degree of sleep, body movement, crying and overall behavior. Vital signs were assessed at three different times. The Wilcoxon, Mann-Whitney, Exact Fisher's and Spearman correlation tests were used to analyze the data. RESULTS: Group I presented higher scores for sleep during the CH session than placebo session during rubber dam application (P = 0.0431) and restoration (P = 0.0431). In Group II there was no statistically significant difference (p > 0.05). There were no statistically significant differences between sessions and groups in the evaluation of body movement, crying and vital signs. Overall behavior in the placebo session was better than in the CH session during local anesthesia, but there was no difference between the two drug regimens. There was influence of age during anesthesia and cavity preparation in Group I and during rubber dam application in Group II. It was concluded that oral diazepam and chloral hydrate had no influence on the behavior management for dental treatment with the studied sample.