Abstract
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.
Highlights
Children’s behavior may change over sequential dental visits (1)
It is assumed that the level of anxiety/behavior in the first session influences the anxiety/behavior in the second session (9), but that has not been proven in the pediatric dental sedation context
There was no significant interaction between the sequence of drug administration and the age category, F(1,14) =0.757, p=0.40, power 0.13, or among drug, sequence of administration and age, F(1,14) =0.829, p=0.38, power 0.14. This is the first study to bring forward evidence favouring the existence of carryover effects of drug experiments in crossover trials regarding pediatric dental sedation
Summary
Children’s behavior may change over sequential dental visits (1). When a child is minimally or moderately sedated for dental treatment, the effect of one visit over another is obscure. To the best of our knowledge, only one crossover trial on pediatric dental sedation investigated the influence of the sequence of sedation appointments on children’s overall behavior; there was no carryover effect as assessed by generalized estimating equation (GEE) logistic regression (10). They compared three sedative regimens: oral meperidine, submucosal meperidine and oral midazolam in healthy preschoolers undergoing pulp therapy; they did not have a control group and did not analyze the interaction between the drug and respective sequence of administration (10). This study investigated the effect of the allocation sequence of the drug (oral midazolam versus placebo), in addition to the drug itself and the child’s age, on the behavior of uncooperative preschool children undergoing two sequential dental visits
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