Conscious sedation by Midazolam in pediatric odontology: A randomized clinical trial

Abstract

Objectives: The objectives of this study are to evaluate the efficacy of midazolam as a means of conscious sedation in pediatric odontology through three routes of administration: oral, rectal and nasal administration, to compare the efficacy of these different routes and to assess the general safety of Midazolam. Materials and Methods: Thirty healthy non-cooperating (ASAI) patients (levels 1 and 2 on the FRANKL scale), aged 2 to 5 years and requiring a minimum of three dental sessions were recruited. Each patient received three sessions of sedation, using a different route of administration each time: oral (0.5 mg/kg), rectal (0.3 mg/kg) and nasal (0.2 mg/kg). The assessment of the behavior throughout the dental care was made using the Houpt scale. Physiological parameters(heart rate and oxygen saturation) were measured every five minutes to assess tolerance. Results: The three routes of administration of midazolam were considered effective since all patients presented a behavior allowing a complete management without interruption of care except for one patient. The sedative effect of the oral and rectal routes was similar, as to the nasal route, it was judged to be clinically better but without any statistically significant differences. The most accepted route of administration by patients was the oral one followed by the nasal and rectal routes. No intolerance to midazolam was observed. Conclusion: Midazolam is an effective sedative for dental care, acceptable by patients and well tolerated regardless of the route of administration.