Abstract
OBJECTIVE: To evaluate the incidence and risk factors of acute adverse drug reactions (ADRs) to nonionic low-osmolar iodinated contrast media (LOCM) in a pediatric population. MATERIALS AND METHODS: This single-center retrospective study included consecutive data on nonionic LOCM injections in pediatric patients (≤18 years) between January 1, 2016, and June 30, 2023. The per-examination incidences of acute ADRs (physiologic and allergic-like reactions) were assessed along with their severities. Multivariable Poisson regression analysis with generalized estimating equations was used to explore the risk factors associated with the occurrence of each ADR type. RESULTS: Among 23,429 injections administered to 13,172 pediatric patients, acute allergic-like reactions occurred in 0.89% (208/23,429) of cases, most of which were mild (0.79%; 186/23,429). Acute physiologic reactions occurred in 0.55% (128/23,429), also predominantly mild (0.50%, 118/23,429). Both types of ADRs occurred slightly more frequently in older patients (allergic-like reactions: adjusted relative risk (RR) = 1.09 per 1-year increase [95% confidence interval {CI}: 1.06, 1.11], P < 0.001; physiologic reactions: adjusted RR = 1.04 per 1-year increase [95% CI: 1.01, 1.07], P = 0.008) and more frequently in those with a history of such reactions (allergic-like reactions = 3.62 [95% CI: 1.44, 9.09], P = 0.006; physiologic reactions = 7.44 [95% CI: 2.55, 21.70], P < 0.001). Acute allergic-like reactions occurred less frequently in inpatient/emergency settings than in outpatient settings (adjusted RR = 0.64 [95% CI: 0.48, 0.85], P = 0.002). Among the 226 examinations with prior allergic-like reactions, recurrent acute allergic-like reactions occurred in 7.26% (9/124) when re-exposed to the same generic LOCM and in 3.92% (4/102) when exposed to a different generic LOCM (P = 0.28). Moderate reactions occurred in three cases that were re-exposed to the same LOCM, whereas all four reactions with different LOCM were mild. CONCLUSION: Acute allergic-like and physiologic reactions to nonionic LOCM occurred in 0.89% and 0.55% of cases, respectively. Older age and a history of prior reactions were significant risk factors. Particular care is warranted during contrast-enhanced CT in these high-risk groups.