The purpose of this study was to compare the clinical safety and effect with and without additional submucosal midazolam to oral chloral hydrate and hydroxyzine when used for pediatric conscious sedation in a clinical dental environment.

Thirty one cases of pediatric conscious sedations were performed in this study. Selection criteria included good health (ASA I), under 6 years old, 20 kg of body weight, uncooperative behavior and the need for sedation to receive dental treatment including anesthesia and restorative or surgical procedure for at least two teeth. In each visit, patients were randomly assigned into one of two groups; CH group: chloral hydrate (60 mg/kg), hydroxyzine (1 mg/kg), CH-M group: chloral hydrate (60 mg/kg), hydroxyzine (1 mg/kg) and submucoal midazolam (0.1 mg/kg). 50% nitrous oxide-oxygen was maintained during the sedation period Sedations were monitored using a pulse oximeter for estimating pulse rate (PR) and percutaneous oxygen saturation (SpO₂). Behavior response rated using Houpt's scale and need of restraint was assessed every 2 minutes through 30 minutes of operative procedure reviewing the videotape recording. Evaluation of overall behavior success was performed using modified overall behavior rate of Houpt's scale. Data was analyzed using t-test.

PR and SpO₂ for both groups remained within the normal values. The mean scores for sleep and movement of CH-M group were higher than those of CH group (P < 0.05). There were no significant difference in mean score for crying between two groups. The mean scores of overall behavior of CH-M group was higher than those of CH group (P < 0.01). Reinstraint of CH-M group was less required than that of CH group (P < 0.05).

Oral chloral hydrate (60 mg/kg) and hydroxyzine (1 mg/kg) combined with submucosal injection of midazolam was safer and showed more improved sedation effect than oral chloral hydrate (60 mg/kg) and hydroxyzine (1 mg/kg) without midazolam for sedation of pediatric dental patients.