Gomes Heloisa Sousa, Daher Anelise, Costa Paulo Sucasas, Batista Aline Carvalho, Costa Luciane Rezende
Faculdade de Odontologia, UNIFENAS - Universidade José do Rosário Vellano, Alfenas, MG, Brazil.
Faculdade de Odontologia, UFG - Universidade Federal de Goiás, Goiânia, GO, Brazil.
Braz Dent J. 2019 Jul 22;30(4):404-409. doi: 10.1590/0103-6440201902852.
Crossover studies continue to be published in spite of warnings about their inherent risks in relation to behavioral outcomes. This study took the opportunity of access to secondary data analysis in order to demonstrate the impact of a crossover design on the outcomes of randomized clinical trials aimed at the behavior of children during dental treatment. We evaluated the effect of the sequence of sedative administration, the sedative and the participant's age on the behavior of children undergoing two sequential dental visits. Eighteen uncooperative healthy young children were equally randomly assigned to: (G1) 1.0 mg/kg oral midazolam (first session) and oral placebo (second session); (G2) oral placebo (first) and 1.0 mg/kg oral midazolam (second). One trained observer assessed children's behavior. Data were analyzed by three-way mixed ANOVA. Both midazolam [mean(SD); 71.7%(16.5)] and placebo [48.6%(33.1)] produced more struggling behavior when they were administered in the first session compared to the second one (p=0.001). For the placebo, children aged 2-3 years exhibited more struggling behavior [G1 54.9%(36.2); G2 80.5%(8.3)] than those aged 4-5 years (p=0.04). Also, the reduction of percentage of struggling behavior was higher in G1 for older children (76.2%) and in G2 for younger children (32.9%). There were significant interactions between drug and sequence of administration, and between drug and age. The results of our study confirm the conventional wisdom that crossover study design is inappropriate to evaluate children's behavior/anxiety related-dental treatment under sedation and the results of crossover studies of dental sedation should be treated with extreme caution.
尽管有关于交叉研究在行为结果方面存在固有风险的警告，但此类研究仍不断发表。本研究利用获取二次数据分析的机会，以证明交叉设计对旨在研究儿童牙科治疗行为的随机临床试验结果的影响。我们评估了镇静剂给药顺序、镇静剂以及参与者年龄对接受两次连续牙科就诊儿童行为的影响。18名不合作的健康幼儿被平均随机分配到：（G1）1.0毫克/千克口服咪达唑仑（第一疗程）和口服安慰剂（第二疗程）；（G2）口服安慰剂（第一疗程）和1.0毫克/千克口服咪达唑仑（第二疗程）。一名经过培训的观察者评估儿童的行为。数据通过三因素混合方差分析进行分析。与第二疗程相比，咪达唑仑[平均值（标准差）；71.7%（16.5）]和安慰剂[48.6%（33.1）]在第一疗程给药时产生的挣扎行为更多（p = 0.001）。对于安慰剂，2至3岁的儿童比4至5岁的儿童表现出更多的挣扎行为[G1为54.9%（36.2）；G（2）为80.5%（8.3）]（p = 0.04）。此外，G1组中年龄较大儿童的挣扎行为百分比降低幅度更高（76.2%），而G2组中年龄较小儿童的降低幅度更高（32.9%）。药物与给药顺序之间以及药物与年龄之间存在显著的交互作用。我们的研究结果证实了传统观点，即交叉研究设计不适用于评估镇静状态下儿童与行为/焦虑相关的牙科治疗，并且牙科镇静交叉研究的结果应极其谨慎地对待。
