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.

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.