Sedative Effect of Oral Midazolam/Hydroxyzine versus Chloral Hydrate/Hydroxyzine on 2–6 Year-Old Uncooperative Dental Patients: A Randomized Clinical Trial

OBJECTIVE Different drugs are used for conscious sedation in pediatric dentistry either single or in combination. This study assessed the comparative effect of midazolam/hydroxyzine and chloral hydrate/hydroxyzine on 2-6 year-old uncooperative children needing dental treatment. MATERIALS AND METHODS A double blind cross-over randomized clinical trial was designed and 16 children aged 2-6 years with ASA1 status who were judged with negative to definitely negative behavior (according to Frankl) were chosen. Cases were divided randomly into two groups. The first group received midazolam/hydroxyzine (MH) at the first visit while the second group received chloral hydrate/hydroxyzine (CHH) as the first medication. Both groups received the other regimen at the second visit. Midazolam 0.5mg/kg and chloral hydrate 50mg/kg with 1mg/kg hydroxyzine were administered. Cases were subsequently assessed for sedation and then dental treatment was performed. Blood oxygen saturation (SpO2) and pulse rate (PR) were measured before and after drug administration, as well as during and after dental treatment. The Houpt scale was also used for the level of sedation before, during and after treatment. Data were analyzed using Wilcox-on signed rank test and the paired t-test. RESULTS Sedative success rate was 64.3% in cases of MH and 33.3% in CHH. The difference between groups was significant (P=0.046). The success rate was significantly different between groups at different measurement stages as well (P<0.05). No difference was found on the child's behavior scale based on the type of drugs used first; this indicates no carry-over effect. Comparing the PR and SpO2 values at different readings showed no significant differences. CONCLUSION Midazolam/hydroxyzine showed a significantly higher sedative effect than chloral hydrate/hydroxyzine in this study.