Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Mínimo flujo de oxígeno necesario para soporte vital durante la simulación de reanimación post parada cardiorrespiratoria / Minimum oxygen flow needed for vital support during simulated post-cardiorespiratory arrest resuscitation

De acuerdo con las guías de la AHA y la ERC, la FiO2 a administrarse debería ser aquella con la que se obtuviera una SatO2 ≥ 94%. El objetivo de este estudio es determinar el mínimo flujo de oxígeno y tiempo necesarios para alcanzar una FiO2 de 0,32 y de 0,80 durante el manejo posparada cardiaca. Se emplearon diferentes reanimadores, que fueron conectados a un pulmón artificial: Mark IV, SPUR II, Revivator Res-Q, O-TWO. Los flujos de oxígeno probados fueron 2, 5, 10 y 15 lpm. Los test estadísticos aplicados fueron Bonferroni y U de Mann-Whitney. Se obtuvo una FiO2 ≥ 0,32 con cualquiera de los flujos de oxígeno y reanimadores. Tras un mínimo de 75 s ventilando con 2 o 5 lpm, solo se consiguió una FiO2 de 0,80 con Mark IV. Se hallaron diferencias clínica y estadísticamente significativas (p < 0,05): con 15 lpm se necesitaron 35 s para alcanzar una FiO2 ≥ 0,80 con Mark IV (85,6 [0,3]) y Revivator (84,3 [1,5]) comparado con los 50 s que precisó SPUR II (87,1 [6,4]); con 2 lpm, todos los resucitadores alcanzaron una FiO2 ≥ 0,32 en 30 s(Mark IV (34,8 [1,3]), Revivator (35,7 [1,5]) y SPUR II (34,4 [2,1]), excepto O-TWO, que necesitó 35 s (36,3 [4,3]). Para alcanzar una FiO2 de 0,32 se podría emplear cualquiera de los resucitadores usando 2 lpm, aunque quizá el menos recomendable sería O-TWO. Si el objetivo fuera una FiO2 de 0,80, debería bastar con 10 lpm, usando preferiblemente Mark IV o Revivator Res-Q. En conclusión, atendiendo a los resultados de nuestro estudio, ante cualquier situación potencial, sería preferible emplear Revivator Res-Q o Mark IV que O-TWO o SPUR II (AU)

According to the ERC and the AHA guidelines, FiO2 should be titrated to achieve an O2Sat ≥ 94%. The aim of this study was to determine the minimum oxygen flow and time needed to reach an FiO2 of 0.32 and 0.80 during post-cardiac arrest care. An experimental analysis was performed that consisted of a simulated post-cardiac arrest situation. Different resuscitators were tested and connected to an artificial lung: Mark IV, SPUR II, Revivator Res-Q, O-TWO. The oxygen flow levels tested were 2, 5, 10 and 15 lpm. Bonferroni and Mann-Whitney U tests were used. An FiO2 of 0.32 or more was obtained using any of the oxygen flow and resuscitators. Only the Mark IV achieved an FiO2 of 0.80 after a minimum of 75 s ventilating with 2 or 5 lpm. Clinical and statistical differences (P < .05) were found: at 15 lpm it took 35 s to reach an FiO2 of 0.80 or more for Mark IV (85.6 [0.3]) and Revivator (84.3 [1.5]) compared to 50 s for SPUR II (87.1 [6.4]); at 2 lpm, all of the devices reached an FiO2 of ≥ 0.32 at 30 s(Mark IV (34.8 [1.3]), Revivator (35.7 [1.5]) and SPUR II (34.4 [2.1]), except for O-TWO, which took 35 s (36.3 [4.3]). Patients could be ventilated with any of the resuscitators using 2 lpm to obtain an FiO2 of 0.32, although possibly O-TWO would be the last option during the first 60 s. In order to reach an FiO2 of 0.80, ventilating with 10 lpm should be sufficient, and preferably using Mark IV or Revivator Res-Q. In conclusion, on observing the results of our study, in any possible scenario, it would be advisable to use Revivator Res-Q or Mark IV rather than O-TWO or SPUR II (AU)

Minimum oxygen flow needed for vital support during simulated post-cardiorespiratory arrest resuscitation.

According to the ERC and the AHA guidelines, FiO2 should be titrated to achieve an O2Sat ≥ 94%. The aim of this study was to determine the minimum oxygen flow and time needed to reach an FiO2 of 0.32 and 0.80 during post-cardiac arrest care. An experimental analysis was performed that consisted of a simulated post-cardiac arrest situation. Different resuscitators were tested and connected to an artificial lung: Mark IV, SPUR II, Revivator Res-Q, O-TWO. The oxygen flow levels tested were 2, 5, 10 and 15 lpm. Bonferroni and Mann-Whitney U tests were used. An FiO2 of 0.32 or more was obtained using any of the oxygen flow and resuscitators. Only the Mark IV achieved an FiO2 of 0.80 after a minimum of 75s ventilating with 2 or 5 lpm. Clinical and statistical differences (P<.05) were found: at 15 lpm it took 35s to reach an FiO2 of 0.80 or more for Mark IV (85.6 [0.3]) and Revivator (84.3 [1.5]) compared to 50s for SPUR II (87.1 [6.4]); at 2 lpm, all of the devices reached an FiO2 of ≥ 0.32 at 30s(Mark IV (34.8 [1.3]), Revivator (35.7 [1.5]) and SPUR II (34.4 [2.1]), except for O-TWO, which took 35s (36.3 [4.3]). Patients could be ventilated with any of the resuscitators using 2 lpm to obtain an FiO2 of 0.32, although possibly O-TWO would be the last option during the first 60s. In order to reach an FiO2 of 0.80, ventilating with 10 lpm should be sufficient, and preferably using Mark IV or Revivator Res-Q. In conclusion, on observing the results of our study, in any possible scenario, it would be advisable to use Revivator Res-Q or Mark IV rather than O-TWO or SPUR II.

Resultados globales en un hospital privado sobre su modelo de gestión quirúrgica / Global results in a private hospital on its management model in day surgery an inpatient surgery

Introducción: El entorno actual pone de manifiesto la necesidad de encontrar modelos de gestión sanitaria con calidad, eficientes y seguros. Las unidades de cirugía mayor ambulatoria se han convertido en un modo de gestionar parte de la actividad quirúrgica con esas características. Actualmente, sin una forma de acreditarlas oficialmente, existen variaciones sobre unas recomendaciones mínimas, originando diferentes modelos, consecuencia de adaptar dicha gestión quirúrgica a las especiales características que cada centro hospitalario tiene. Material y métodos: Proponemos en el presente trabajo nuestro particular modelo de gestión quirúrgica, nacido de nuestras circunstancias, junto a los principales indicadores objetivos de actividad y de calidad, y que han originado el reconocimiento por parte de una auditoría externa tras valorar a 163 centros hospitalarios, de una manera voluntaria, gratuita y confidencial y en todo el territorio nacional. Resultados: Nuestro modelo de gestión quirúrgica que integra, tanto la cirugía sin ingreso como la ambulatoria, basado en modelos de actuación coordinados sobre la misma estructura física y organizativa ha propiciado que un hospital, de tan solo 90 camas, consiga realizar 17.366 intervenciones anuales en base a una tasa bruta de ambulatorización del 78-80 %, con unos índices de calidad superiores a la media de otros hospitales, de similares características; una tasa bruta de mortalidad del 1,3 (0,802 si la ajustamos por riesgo), una tasa de complicaciones del 1,7 (1,04 si la ajustamos por riesgo) y una tasa de readmisiones (..) (AU)

Introduction: The actual environment outlines the need of finding high quality management models that are efficient and safe. Ambulatory surgery facilities have become a way of managing part of the surgical activity with such features. Nowadays, with no means of formal accreditation, multiple variations exist on what should be considered minimum recommendations for this type of facility. This results in different models, as a consequence of adapting such surgical management to the special features that each hospital possesses. Materials and method: In our present study, we present our own surgical management model, adapted to fit our circumstances. We also present main objective quality indicators for surgical activity that have earned us recognition from an external audit that assessed 163 hospital facilities voluntarily, confidentially and wantonly across the country . Results: Our surgical management model includes day surgery and inpatient surgery and is based on performance models coordinated on the same physical and organizational structure. This has enabled a hospital facility of only 90 beds to achieve 17,366 surgeries a year, with a gross rate of ambulatory surgery of 70-80% and with quality indicators above the majority (..) (AU)