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The following is a summary of “Adverse Drug Reactions in Pediatric Surgery: Prospective Study on Frequency and Risk-Related Factors,” published in the May 2024 issue of Pediatrics by Pérez-Ingidua et al.

Adverse drug reactions (ADRs) pose significant risks to pediatric patients, particularly in surgical settings where multiple factors can contribute to their occurrence. Despite this, the literature on ADRs in pediatric surgery remains limited. This study aimed to quantify the frequency of ADRs in this population and investigate associated characteristics and risk factors.

The researchers conducted a prospective observational study involving 311 pediatric patients aged 1–16 years undergoing surgery at a tertiary referral hospital in Spain from 2019 to 2021. ADR frequencies were assessed using incidence rates, while odds ratios (ORs) were calculated to analyze the influence of potential risk factors on ADR development.

Among the cohort, 80 patients (25.7%) experienced 103 distinct ADRs, with hypotension (35%), nausea (15.5%), and emergence delirium (15.5%) being the most common. Drug-drug interactions, notably involving sevoflurane and fentanyl (31.1%), were the primary cause of ADRs. The strongest predictor of ADRs was the number of off-label drugs prescribed per patient (OR = 2.99, 95% CI 1.73 to 5.16), followed by the total number of drugs prescribed (OR = 1.26, 95% CI 1.13 to 1.41) and older age (OR = 1.26, 95% CI 1.07 to 1.49). ADR severity, assessed by Venulet criteria and the Spanish Pharmacovigilance System, classified only 3.9% of ADRs as serious.

This study highlights a high incidence of ADRs among patients with pediatric surgery, with off-label drug use emerging as a significant risk factor. Effective management strategies are needed to mitigate these risks, emphasizing the importance of tailored prescribing practices and vigilant pharmacovigilance in pediatric surgical care.

Source: bmcpediatr.biomedcentral.com/articles/10.1186/s12887-024-04803-1