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Acute Adverse Reactions to Nonionic Low-Osmolar Iodinated Contrast Media in Children: A Retrospective Study of 23,429
Yewon Seong1, Pyeong Hwa Kim2, Chong Hyun Suh3
1University of Ulsan College of Medicine, Seoul, Republic of Korea.
Insights
Acute adverse drug reactions (ADRs) to nonionic low-osmolar iodinated contrast media (LOCM) occurred in 0.89% of pediatric cases. Older age and prior reaction history are key risk factors for ADRs in children receiving LOCM.
Area of Science:
- Pediatric Radiology
- Pharmacovigilance
- Medical Imaging Safety
Background:
- Adverse drug reactions (ADRs) to iodinated contrast media can occur in pediatric patients.
- Nonionic low-osmolar contrast media (LOCM) are commonly used, necessitating an understanding of their safety profile in children.
Purpose of the Study:
- To determine the incidence of acute ADRs to nonionic LOCM in pediatric patients.
- To identify risk factors associated with these ADRs in the pediatric population.
Main Methods:
- Retrospective analysis of 23,429 nonionic LOCM injections in pediatric patients (≤18 years) from January 2016 to June 2023.
- Assessment of per-examination incidences and severities of acute physiologic and allergic-like ADRs.
- Multivariable Poisson regression with generalized estimating equations to identify risk factors.
Main Results:
- Acute allergic-like reactions occurred in 0.89% and physiologic reactions in 0.55% of pediatric LOCM injections, mostly mild.
- Older age and a history of prior ADRs were significant risk factors for both reaction types.
- Inpatient/emergency settings showed lower rates of allergic-like reactions compared to outpatient settings.
Conclusions:
- Nonionic LOCM ADRs are infrequent in pediatric patients but associated with specific risk factors.
- Older children and those with a history of reactions require heightened vigilance during contrast-enhanced procedures.
- These findings support targeted safety measures for high-risk pediatric populations undergoing contrast-enhanced imaging.
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.
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