A randomized double-blind trial of chloral hydrate/hydroxyzine versus midazolam/acetaminophen in the sedation of pediatric dental outpatients.

The purpose of this study was to evaluate in a randomized, double-blinded fashion the sedative and behavioral responses of children undergoing pediatric dental procedures as outpatients and who had received a combination of either oral chloral hydrate 50 mg/kg, not to exceed 1 gm, with hydroxyzine 25 mg (Group 1); or oral midazolam 0.5 mg/kg with acetaminophen elixir 10 mg/kg (Group 2). The children were rated according to sleep, movement, crying and overall behavior at preselected intervals that included presedation, introduction to the operating suite, injection, and overall behavior. There were no statistical differences between the two groups in regards to age, weight, length of procedure, or sex. Group 1 was more asleep in the later time intervals (P < 0.05). Their were no statistically significant differences between the groups in relation to the overall evaluation for the procedure. In conclusion, midazolam/acetaminophen is as effective as chloral hydrate/hydroxyzine in the sedation of young children undergoing outpatient dental procedures.

RCT Entities:   Population Interventions Outcomes