Eficácia da sedação intranasal com midazolam e cetamina no controle comportamental de crianças submetidas a tratamento odontológico: ensaio clínico randomizado

Abstract

During dental treatment of children, basic or advanced behavior guidance techniques can be used. Advanced techniques, non-pharmacological (protective stabilization) or pharmacological (sedation and general anesthesia), are indicated when there is no success with the basic techniques. Regarding advanced techniques, sedation has been increasingly widespread in pediatric dentistry, although the evidence is still weak about which sedative regime provides the greatest comfort and the lowest risk. In view of this need to identify the best sedative regimen, the objective of this randomized, masked, controlled, parallel-design trial was to evaluate the effectiveness of intranasal sedation with Midazolam and Ketamine in behavioral control of preschool children undergoing dental treatment. Eighty-four preschoolers, aged between 1.5 and 6 years old, with dental caries and non-cooperative behavior in previous dental treatment, were randomized into three groups: (1) Midazolam and Ketamine intranasally (MKI); (2) Midazolam and oral ketamine (MKO); (3) Oral midazolam. In all groups, the sedative was administered by a pediatrician or anesthesiologist, and the children received restorative treatment under local anesthesia and rubber dam isolation. Dental treatment was performed by pediatric dentists who, in the end, classified child behavior through the Frankl scale. The training sessions were videotaped, and the videos were then analyzed by trained and calibrated researchers to assess behavior using the Ohio State University Behavioral Rating Scale (OSUBRS) scale. The need to discontinue care and to use protective stabilization was recorded. The data obtained were organized and analyzed in the software Statistical Package for Social Sciences (SPSS). The statistical analysis involved the description of the data and bivariate tests, considering a level of significance of 5%. Considering as a parameter for sedation success the "positive" or "definitely positive" behavior verified with the Frankl scale, the following rates were observed: MKI - 50.0%; MKO - 64.3% and MO - 28.6%. Success rates differed significantly between MKO compared to MKI and MO (P = 0.03). When comparing the groups in relation to the behavior evaluated by the OSUBRS scale, no statistically significant difference was observed in the frequency of "quiet" (P = 0.22), "movement without crying" (P = 0.69) and "combative (P = 0.30). The groups did not differ in assessing the number of cases in which there was a "quiet" behavior in at least 51.7% (median) of the session duration (P = 0.27) and in the number of cases in which the child was "combative" "In at least 24.5% (median) of the session duration (P = 0.65). The need to suspend treatment (P = 0.69) and use protective stabilization (P = 0.14) did not differ significantly among the three groups. The results of behavior evaluation using the Frankl and OSUBRS scale were strongly correlated (rho = -0.84, P0.01). From these results, it was concluded that the sedative protocol MKO presented a higher success rate in behavioral control when compared to the other groups (MKI and MO). The combination of Midazolam and Ketamine, regardless of route of administration, was more effective in controlling behavior than Midazolam given alone. Therefore, the use of the combination of Midazolam and Ketamine, both orally and intranasally, is an effective alternative for controlling the behavior of non-collaborating preschoolers.