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.
Background. The aim of this investigation was to compare the sedative effects of oral midazolam/chloral hydrate and midazolam/promethazine combinations on fearful children needing dental treatment.
Methods. This crossover double-blind clinical trial was conducted on 30 children aged 2‒6 years, who had at least two similar teeth needing pulp treatment. Standard vital signs were recorded before and after premedication. Wilson sedation scale was used to judge the level of sedation. Cases were divided into two groups based on the sequence of medication received. This was to overcome the sequence effect. Group I received oral midazolam (0.4 mg/kg/chloral hydrate (50 mg/kg) at the first visit while they received midazolam (0.4 mg/kg)/promethazine (5 mg/kg) in their second visit. Group II received the premedication in the opposite sequence. The operator and child were blinded to the medication administered. Sedative efficacy of the two combinations were assessed and judged by two independent pediatric dentists based on the Wilson scale. Data were analyzed with ANOVA and paired t-test.
Results. Only 10% of children who received chloral hydrate with midazolam exhibited high improvement in their behavior
while 53% showed reasonable positive changes and 12% had no change or even deterioration of behavior. The difference
between the effect of the two combination drugs was statistically significant (P<0.05) in favor of the chloral hydrate group.
Conclusion. The results showed a significant difference in the sedation level induced between the two groups. Midazolam/chloral hydrate combination more effectively improved the co-operation for dental treatment.
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