BACKGROUND AND OBJECTIVE: The use of midazolam for conscious sedation is an accepted method of anxiety control in restorative dentistry. A lack of predictability in its effects requires the dose of midazolam to be adjusted to individual patient's requirements. We determined whether patient-controlled sedation was a suitable alternative to operator-controlled sedation in restorative dentistry. METHODS: A randomized crossover clinical trial involving 35 consecutive patients undergoing similar dental procedures. Patients were randomly given midazolam, administered either by the patient or by the operator at the first visit and the alternative option on the second visit. All patients were ASA I-II and their ages ranged between 20 and 48 yr. Blood pressure, heart rate, oxygen saturation and patient satisfaction were recorded. RESULTS: The onset time and initial dose for sedation were similar with the two methods of administration and the sedation scores and vital signs were satisfactory. In the patient-controlled group the mean total dose of midazolam was 7.9 (+/- 4.2 SD) mg cf. 4.2 (+/- 1.8 SD) mg in the operator-controlled group (P < 0.05). The time to fitness for discharge (15.4 (+/- 11.9 SD) min) was greater in the patient-controlled group cf. the operator-controlled group (8.5 (+/- 9.5 SD) min), P < 0.05. CONCLUSION: This study shows that patient-controlled sedation is a suitable alternative to operator-controlled sedation in the management of anxious dental patients.
RCT Entities:
BACKGROUND AND OBJECTIVE: The use of midazolam for conscious sedation is an accepted method of anxiety control in restorative dentistry. A lack of predictability in its effects requires the dose of midazolam to be adjusted to individual patient's requirements. We determined whether patient-controlled sedation was a suitable alternative to operator-controlled sedation in restorative dentistry. METHODS: A randomized crossover clinical trial involving 35 consecutive patients undergoing similar dental procedures. Patients were randomly given midazolam, administered either by the patient or by the operator at the first visit and the alternative option on the second visit. All patients were ASA I-II and their ages ranged between 20 and 48 yr. Blood pressure, heart rate, oxygen saturation and patient satisfaction were recorded. RESULTS: The onset time and initial dose for sedation were similar with the two methods of administration and the sedation scores and vital signs were satisfactory. In the patient-controlled group the mean total dose of midazolam was 7.9 (+/- 4.2 SD) mg cf. 4.2 (+/- 1.8 SD) mg in the operator-controlled group (P < 0.05). The time to fitness for discharge (15.4 (+/- 11.9 SD) min) was greater in the patient-controlled group cf. the operator-controlled group (8.5 (+/- 9.5 SD) min), P < 0.05. CONCLUSION: This study shows that patient-controlled sedation is a suitable alternative to operator-controlled sedation in the management of anxious dentalpatients.