Comparison of oral Midazolam-Ketamine and Midazolam-Promethazine as sedative agents in pediatric dentistry

BACKGROUND: Investigation was designed to evaluate the behavioral changes in children receiving dental treatment while they have been administered combination of Midazolam/Ketamine or Midazolam/Promethazine. MATERIALS AND METHODS: This was a randomized double blind clinical trial with cases being selected from those uncooperative children aged 2 to 6 years from those referred for treatment under general anesthesia. Anxiety score of all cases were recorded before any attempt using Frankel's anxiety scoring system with those in negative category being included. Cases with at least a pair of similar size cavities on similar teeth were selected with each tooth being randomly allocated for one sedative regimen group. To avoid sequence effect, half of the patients received one regimen at the first visit while the other half received the other regimen as the first. Each case served as control for him or herself to reduce influencing factors. Child's reaction was recorded before, during, and at the end of dental procedure. SO2 as well as Pulse rate were recorded as the most critical vital signs. Collected data were then analyzed using analysis of variance (ANOVA) and paired t-test. RESULTS: Patients’ mean age was 3.5 years with 43% being male. Only 10% of the Ketamine/Midazolam group showed considerable amount of change in their behavior with a statistical significant difference being presented (P=0.029). CONCLUSION: Under the current circumstances, Ketamine/Midazolam combination provided sufficient sedative effect in lower doses. However, Midazolam/Promethazine combination did not produce similar results.