Clinical Pharmacology Department, Hospital Clínico San Carlos, Madrid, Spain.
Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain.
BMC Pediatr. 2024 May 18;24(1):344. doi: 10.1186/s12887-024-04803-1.
Paediatric patients are especially prone to experiencing adverse drug reactions (ADRs), and the surgical environment gathers many conditions for such reactions to occur. Additionally, little information exists in the literature on ADRs in the paediatric surgical population. We aimed to quantify the ADR frequency in this population, and to investigate the characteristics and risk factors associated with ADR development.
A prospective observational study was conducted in a cohort of 311 paediatric patients, aged 1-16 years, admitted for surgery at a tertiary referral hospital in Spain (2019-2021). Incidence rates were used to assess ADR frequency. Odds ratios (ORs) were calculated to evaluate the influence of potential risk factors on ADR development.
Distinct ADRs (103) were detected in 80 patients (25.7%). The most frequent being hypotension (N = 32; 35%), nausea (N = 16; 15.5%), and emergence delirium (N = 16; 15.5%). Most ADRs occurred because of drug-drug interactions. The combination of sevoflurane and fentanyl was responsible for most of these events (N = 32; 31.1%). The variable most robustly associated to ADR development, was the number of off-label drugs prescribed per patient (OR = 2.99; 95% CI 1.73 to 5.16), followed by the number of drugs prescribed per patient (OR = 1.26, 95% CI 1.13 to 1.41), and older age (OR = 1.26, 95% CI 1.07 to 1.49). The severity of ADRs was assessed according to the criteria of Venulet and the Spanish Pharmacovigilance System. According to both methods, only four ADRs (3.9%) were considered serious.
ADRs have a high incidence rate in the paediatric surgical population. The off-label use of drugs is a key risk factor for ADRs development.
儿科患者特别容易发生药物不良反应（ADR），而手术环境聚集了许多发生此类反应的条件。此外，文献中关于儿科手术人群中 ADR 的信息很少。我们的目的是量化该人群中 ADR 的发生率，并研究与 ADR 发展相关的特征和危险因素。
这是一项在西班牙一家三级转诊医院接受手术的 311 名 1-16 岁儿科患者的前瞻性观察性研究（2019-2021 年）。使用发生率来评估 ADR 的频率。计算比值比（ORs）来评估潜在危险因素对 ADR 发展的影响。
在 80 名患者（25.7%）中发现了不同的 ADR（103 个）。最常见的是低血压（N=32；35%）、恶心（N=16；15.5%）和苏醒谵妄（N=16；15.5%）。大多数 ADR 是由于药物相互作用引起的。七氟醚和芬太尼的联合使用是这些事件的主要原因（N=32；31.1%）。与 ADR 发展最密切相关的变量是每位患者开的标签外药物数量（OR=2.99；95%CI 1.73 至 5.16），其次是每位患者开的药物数量（OR=1.26，95%CI 1.13 至 1.41）和年龄较大（OR=1.26，95%CI 1.07 至 1.49）。根据 Venulet 和西班牙药物警戒系统的标准评估 ADR 的严重程度。根据这两种方法，只有 4 个 ADR（3.9%）被认为是严重的。
ADR 在儿科手术人群中有很高的发生率。药物的标签外使用是 ADR 发展的关键危险因素。
