Tramadol Use in Pediatric Surgery: Trends After the Food and Drug Administration Black-Box Warning

Abstract

IntroductionThe U.S. Food and Drug Administration (FDA) issued a black-box warning in 2017 contraindicating tramadol in children <12 y. Longitudinal trends and factors associated with perioperative tramadol use in children remain unclear. MethodsA retrospective, multi-institutional cohort study utilizing the Pediatric Health Information System database was performed for children 2-18 y who underwent one of ten common surgeries from 1/2009-2/2020. Temporal trends correlated with the FDA tramadol contraindication were evaluated. Hierarchical multivariable logistic regression analysis identified factors associated with tramadol use. ResultsOf 477,153 children undergoing surgery, 5857(1.2%) received tramadol during hospitalization. Tramadol use occurred in 942 (16.1%) children after the black-box warning, 390 of whom were <12 y. For children <12 y, annual tramadol use peaked at 1.87% (2016) and decreased to 0.66% (2019). Female sex (odds ratio OR 1.32; 95% confidence interval CI:1.24,1.40), age ≥12 y (OR 2.79; 95%CI: 2.62,2.97), and Midwest location (OR 4.07; 95% CI:1.64,10.11) increased likelihood of receiving tramadol. Tramadol use was more likely after cholecystectomy (OR 1.17; 95% CI:1.04,1.32) and in children with gastrointestinal (OR 2.39; 95% CI: 2.19,2.60), metabolic (OR 1.39; 95% CI:1.26,1.53) or transplant-related (OR 1.82; 95% CI: 1.57,2.10) comorbidities. Children of Hispanic/Latino ethnicity and those with public insurance had decreased likelihood of receiving tramadol. Adjusting for patient and hospital characteristics, children <12 y were less likely to receive tramadol following the black-box warning (OR 0.65; 95% CI: 0.59,0.70). ConclusionsDespite the FDA contraindication, tramadol prescribing continues among children <12 y undergoing surgery, with use varying by patient and institutional factors. Interventions are required to reduce perioperative tramadol use in children.