[Effectiveness and Safety of Oral Midazolam Combined Nitrous Oxide Sedation in Treating Children with Dental Fear].

Objective To evaluate the safety and effectiveness of oral midazolam sedation combined nitrous oxide sedation for reducing dental fear in children.Methods Totally 77 children with a Frankl's Behavior Rating Scale score of 1 were included in this study,among whom 41 received a total of 78 person-times of oral midazolam sedation (0.50-0.75 mg·kg ) (midazolam group) and 36 children were treated with the combination of 0.4 mg/kg oral midazolam with 30%-40% nitrous oxide (totally 73 person-times)(combination group). At each visit,heart rate,arterial oxygen saturation,and treatments were recorded. The behaviors of children during the treatment were assessed by Frankl's Behavior Rating Scale,the completion of treatment was assessed by Houpt Scale,and the sedation status was assessed by Ramsay Scale. Telephone follow-up was performed to record the side effects 24 hours after treatment. Results The vital signs were stable among all the 77 subjects,with a Ramsay score of 2 or 3. In the midazolam group, the behaviors were cooperative in 52 person-times (66.7%) and not cooperative in 26 person-times (33.3%);the planned treatments were completed in 62 person-times (79.5%) and partially completed in 16 person-times(20.5%). In the combination group,the behaviors were cooperative in 56 person-times (76.7%) and not cooperative in 17 person-times (23.3%);64 person-times (87.7%) completed the planned treatments and 9 person-times (12.3%) partially completed the treatments. The success rates of sedation (χ =1.87,P= 0.17) and treatment (χ =1.83,P= 0.18) were not significantly different between these two groups. The median Frankl scale score was significantly higher in the combination group [3 (3,4)] than in the midazolam group [3 (2,4)] (Z=2.647,P=0.008]. The median score of Houpt scale in the combination group [5(4,6)] was also significantly higher than in midazolam group [5(3,5)] (Z=2.236,P=0.026]. In midazolam group,there were 7 person-times of dysphoria,3 person-times of diplopia,and 2 person-times of hiccough among 78 person-times;in the combination group,there were 5 person-times of dysphoria,5 person-times of diplopia,1 person-time of hiccough,and 2 person-times of vomit among 73 person-times of treatment. Thus,there was no significant difference in the incidence of side effects (15.4% vs.17.8%,χ =0.160,P=0.689). Logistic regression analysis showed that the success rate of treatment was not associated with sex (OR=1.704,P=0.174),dose (OR=1.289,P=0.516),and treatment types (OR=0.555,P=0.143). Children over 3 years old had a significantly high success rate than those under 3 years old (OR=3.372,P=0.011). Conclusions Oral midazolam is safe and effective for reducing dental fear in children. The combination of oral midazolam with 30%-40% nitrous oxide can improve the behaviors of children during the dental treatment,especially in children over 3 years old.