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 midazo- lam/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 de- signed 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 ran- domly 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 med- ication. 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 oxy- gen saturation (SpO2) and pulse rate (PR) were measured before and after drug admin- istration, 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 differ- ence between groups was significant (P=0.046). The success rate was significantly differ- ent 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.