OBJECTIVE: This study compared the efficacy of local intraosseous anesthesia using a computerized device (QuickSleeper 5) to conventional IANB anesthesia on cooperation and pain perception in children, using a randomized controlled trial design.
METHODS: The study included 88 healthy children, aged between 6 and 9 years, who required pulpotomy for their mandibular second primary molars. The study was approved by the local research ethics committee and registered at clinicaltrials.gov (NCT05193487). The heart rate and Venham behavior rating scale were recorded and analyzed. Categorical data were analyzed using Fisher\'s exact test. Age and heart rate were compared using an independent t-test for intergroup comparison. The intragroup comparison was carried out using repeated measures ANOVA, followed by the Bonferroni post hoc test. The Mann-Whitney U-test was used to analyze the Venham scale scores. The significance level was set at p < .05 RESULTS: The mean Venham score was slightly higher in the IANB group than in the CIOA group, but was not statistically significant (p = .852). One minute after anesthesia administration, the heart rate (beats per minute [BPM]) was significantly higher in the IANB group (92.30 ± 13.45) than in the CIOA group (83.20 ± 10.40) (p < .001). Additionally, there was a significant difference in heart rate values measured at different intervals within the IANB group.
CONCLUSIONS: The QuickSleeper 5 device was found to be a feasible alternative for IANB in children over 6 years old.
目的:本研究比较了使用计算机化设备(QuickSleeper5)的局部骨内麻醉与常规IANB麻醉对儿童合作和疼痛感知的疗效,使用随机对照试验设计。
方法:该研究包括88名健康儿童,年龄在6至9岁之间,他们的下颌第二磨牙需要牙髓切除术。该研究得到了当地研究伦理委员会的批准,并在clinicaltrials.gov(NCT05193487)注册。记录并分析心率和Venham行为评定量表。分类数据采用Fisher精确检验进行分析。使用独立t检验进行组间比较,比较年龄和心率。使用重复测量方差分析进行组内比较,其次是Bonferroni事后测试。Mann-WhitneyU检验用于分析Venham量表得分。显著性水平设定为p<0.05。结果:IANB组的平均Venham评分略高于CIOA组,但没有统计学意义(p=.852)。麻醉后一分钟,IANB组(92.30±13.45)的心率(每分钟心跳[BPM])明显高于CIOA组(83.20±10.40)(p<.001)。此外,在IANB组中,在不同时间间隔测得的心率值存在显著差异.
结论:在6岁以上的儿童中,QuickSleeper5设备被发现是IANB的可行替代品。