Aim: Due to a lack of age-appropriate formulations, administration of drugs to children remains a challenge. This study aimed to identify the problems experienced in both the outpatient setting and the clinical setting.prospective study at the Sophia Children's Hospital, The Netherlands. The study comprised of a structured interview on drug manipulations with parents visiting the outpatient clinic, and an observational study of drug manipulations by nurses at the wards.Results: A total of 201 questionnaires were collected, accounting for 571 drugs and 169 manipulations (30%). Drug substances that were most often mentioned as manipulated were macrogol (n = 23), esomeprazole (n = 15), paracetamol (n = 8), methylphenidate (n = 7) and melatonin (n = 7). Of all manipulated medicines, 93/169 (55%) were manipulated according to the instructions or recommendations of the Summary of Product Characteristics (SmPC) or patient information leaflet. During the observational study, manipulation was performed by 21/35 of observed nurses (60%), of whom 11 deviated from the hospital protocol for manipulation or SmPC (52%). Conclusion:Manipulation was a widely used method to administer drugs to children.Validated information regarding manipulation of drugs for both parents and nursing staff is needed.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.Oral drug manipulation for paediatric patients van der Vossen et al.

Aims: This study explores the impact of paediatric patient related factors and choice of formulation on the dissolution characteristics of nifedipine and lorazepam, 2 drug substances regularly applied in very young patients and in compounded formulations.Methods: Dissolution experiments were designed to reflect clinical practice in a paediatric hospital, with respect to dosage forms, feeding regimens and methods of administration. Solubility studies addressed the influence of age and prandial state.Drug solubility and dissolution experiments were conducted in biorelevant media and adapted age-specific (neonate and infant) media. Dissolution studies were performed with the mini-paddle apparatus and the flow-through cell apparatus.Results: Dissolution of nifedipine formulations was not affected by age-related changes of the fasted state simulated gastrointestinal fluids, and by disintegration of the formulation before administration. However, a significant difference in nifedipine's dissolution rate from commercial tablets and compounded capsules was observed. The dissolution of lorazepam tablets was affected by fasted-vs fed-state media, but it was deemed less likely to be clinically relevant. The significant effect of fed-state media on nifedipine's solubility was considered to have possible clinical relevance since very young patients are almost continuously in a fed state. Conclusion:The in vitro results obtained from these studies reveal the potential of biorelevant solubility and dissolution studies reflecting clinical practice to predict drug performance in paediatric patients.

AimIntravenous sedatives used in the paediatric intensive care unit (PICU) need to be tapered after prolonged use to prevent iatrogenic withdrawal syndrome (IWS). We evaluated the occurrence of IWS and the levels of sedation before and after conversion from intravenous midazolam to oral lorazepam.MethodsThis was a retrospective, observational, single cohort study of children under the age of 18 admitted to the PICU of the Erasmus MC‐Sophia Children's Hospital, Rotterdam, The Netherlands, between January 2013 and December 2014. The outcome parameters were the Sophia Observation withdrawal Symptoms (SOS) scale scores and COMFORT Behaviour scale scores before and after conversion.ResultsOf the 79 patients who were weaned, 32 and 39 had before and after SOS scores and 77 had COMFORT‐B scores. IWS was reported in 15 of 79 patients (19.0%) during the 48 hours before the start of lorazepam and 17 of 79 patients (21.5%) during the 48 hours after treatment started. Oversedation was seen in 16 of 79 patients (20.3%) during the 24 hours before substitution and in 30 of 79 patients (38.0%) during the 24 hours after substitution.ConclusionThe weaning protocol was not able to prevent IWS in all patients, but converting from intravenous midazolam to oral lorazepam did not increase the incidence.

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