Clinical Evaluation of the Effects of two Types of Oral Combination of Midazolam in Sedating Pediatric Dental Patients

Abstract

<strong>Statement of Problem: </strong>Conscious sedation is frequently employed for the management of precooperative or extremely anxious dental patients. Many medications have been used to sedate children in the dental office separately and in combination in an attempt to find an ideal sedation regimen. However, it seems that there is a need for finding a drug with more effectiveness and lower complications.<br /> <strong>Purpose: </strong>This study was undertaken to compare the effectiveness of oral combinations of midazolam/ketamine and midazolam/ hydroxyzine in sedating pediatric dental patients.<br /> <strong>Materials and Method:</strong> In this prospective, double-blinded, crossover clinical study, 25 uncooperative children, ages 37 to 56 months (mean age of 48.1 months), in need of at least 2 restorative visits were selected. The subjects were assigned randomly to receive either a combination of midazolam 0.5 mg/kg and ketamine 5mg/kg or midazolam 0.5 mg/kg and hydroxyzine 2 mg/kg prior to dental treatment at the first appointment. The alternative drug regimen was administered at the second appointment. All the subjects also received 50% nitrous oxide/oxygen during treatment. The child's behavior, in all 4 behavioral criteria including sleeping, crying, body movement and overall behaviors, during injection and procedure, was evaluated by an independent clinician who was unaware of the drug given to the child. The data were analyzed using Wilcoxon and McNemar tests.<br /> <strong>Results:</strong> Midazolam/ketamine was found to be significantly more effective than midazolam/ hydroxyzine during injection and procedure for sleeping ( <em>p </em>=0.00, <em>p </em>=0.001, respectively), crying ( <em>p </em>=0.00, <em>p </em>=.001) and body movement<br /> ( <em>p </em>=0.001, <em>p</em> =0.001) and was moresuccessful, according to the overall behavior evaluation criteria ( <em>p </em>=0.008).<br /> <strong>Conclusion:</strong> Midazolam/ ketamineresulted in safe and effective sedation for the dental treatment of young children and in comparison to midazolam/ hydroxyzine, it resulted in less sleeping, crying, movement and better overall behavior during the dental treatment.