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

Abstract

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.
Key Words: Children, dental fear, ketamine, midazolam, oral sedation, promethazine