Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a multi-center randomized controlled trial.

BACKGROUND: To determine whether intermittent intravenous (IV) paracetamol as primary analgesic would significantly reduce morphine consumption in children aged 0-3 years after cardiac surgery with cardiopulmonary bypass. METHODS: Multi-center, randomized, double-blinded, controlled trial in four level-3 Pediatric Intensive Care Units (PICU) in the Netherlands and Belgium. Inclusion period; March 2016-July 2020. Children aged 0-3 years, undergoing cardiac surgery with cardiopulmonary bypass were eligible. Patients were randomized to continuous morphine or intermittent IV paracetamol as primary analgesic after a loading dose of 100 mcg/kg morphine was administered at the end of surgery. Rescue morphine was given if numeric rating scale (NRS) pain scores exceeded predetermined cutoff values. Primary outcome was median weight-adjusted cumulative morphine dose in mcg/kg in the first 48 h postoperative. For the comparison of the primary outcome between groups, the nonparametric Van Elteren test with stratification by center was used. For comparison of the proportion of patients with one or more NRS pain scores of 4 and higher between the two groups, a non-inferiority analysis was performed using a non-inferiority margin of 20%. RESULTS: In total, 828 were screened and finally 208 patients were included; parents of 315 patients did not give consent and 305 were excluded for various reasons. Fourteen of the enrolled 208 children were withdrawn from the study before start of study medication leaving 194 patients for final analysis. One hundred and two patients received intermittent IV paracetamol, 106 received continuous morphine. The median weight-adjusted cumulative morphine consumption in the first 48 h postoperative in the IV paracetamol group was 5 times lower (79%) than that in the morphine group (median, 145.0 (IQR, 115.0-432.5) mcg/kg vs 692.6 (IQR, 532.7-856.1) mcg/kg; P < 0.001). The rescue morphine consumption was similar between the groups (p = 0.38). Non-inferiority of IV paracetamol administration in terms of NRS pain scores was proven; difference in proportion - 3.1% (95% CI - 16.6-10.3%). CONCLUSIONS: In children aged 0-3 years undergoing cardiac surgery, use of intermittent IV paracetamol reduces the median weight-adjusted cumulative morphine consumption in the first 48 h after surgery by 79% with equal pain relief showing equipoise for IV paracetamol as primary analgesic. Trial Registration Clinicaltrials.gov, Identifier: NCT05853263; EudraCT Number: 2015-001835-20.

Low-value home-based nursing care: A national survey study.

AIMS: To explore potential areas of low-value home-based nursing care practices, their prevalence and related influencing factors of nurses and nursing assistants working in home-based nursing care. DESIGN: A quantitative, cross-sectional design. METHODS: An online survey with questions containing scaled frequencies on five-point Likert scales and open questions on possible related influencing factors of low-value nursing care. The data collection took place from February to April 2022. Descriptive statistics and linear regression were used to summarize and analyse the results. RESULTS: A nationwide sample of 776 certified nursing assistants, registered nurses and nurse practitioners responded to the survey. The top five most delivered low-value care practices reported were: (1) 'washing the client with water and soap by default', (2) 'application of zinc cream, powders or pastes when treating intertrigo', (3) 'washing the client from head to toe daily', (4) 're-use of a urinary catheter bag after removal/disconnection' and (5) 'bladder irrigation to prevent clogging of urinary tract catheter'. The top five related influencing factors reported were: (1) 'a (general) practitioner advices/prescribes it', (2) 'written in the client's care plan', (3) 'client asks for it', (4) 'wanting to offer the client something' and (5) 'it is always done like this in the team'. Higher educational levels and an age above 40 years were associated with a lower provision of low-value care. CONCLUSION: According to registered nurses and certified nursing assistants, a number of low-value nursing practices occurred frequently in home-based nursing care and they experienced multiple factors that influence the provision of low-value care such as (lack of) clinical autonomy and handling clients' requests, preferences and demands. The results can be used to serve as a starting point for a multifaceted de-implementation strategy. REPORTING METHOD: STROBE checklist for cross-sectional studies. PATIENT OR PUBLIC CONTRIBUTION: No Patient or Public Contribution. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Nursing care is increasingly shifting towards the home environment. Not all nursing care that is provided is effective or efficient and this type of care can therefore be considered of low-value. Reducing low-value care and increasing appropriate care will free up time, improve quality of care, work satisfaction, patient safety and contribute to a more sustainable healthcare system.

Nurses' perceptions of the transition to 100% single-occupancy patient rooms in a university hospital in the Netherlands: an uncontrolled before and after study.

BACKGROUND: To improve patients' privacy, comfort and infection control, newly built hospitals increasingly offer 100% single-occupancy patient rooms. Our study examines how nurses perceived the transition from a hospital with multi-bedded patient rooms to one with solely single-occupancy patient rooms designed according to principles of a healing environment. METHODS: In a single-centre, before-after survey study, nurses completed a questionnaire of 21 items in three domains: perceived patient safety and monitoring, nurses' working conditions and patient environment. Before-measurements (n = 217) were compared with two after-measurements in the new hospital, respectively after one (n = 483) and two years (n = 191). RESULTS: Nurses considered the single rooms in the new hospital worse for visibility and monitoring but this had improved somewhat after two years. In either setting, the majority perceived working conditions (walking distances and designated rest area) as unfavourable. The patient environment in the new hospital was generally perceived as much better than in the former hospital. CONCLUSION: The transition to solely single-occupancy patient rooms was largely considered positive by nurses in terms of patient environment. However, monitoring of patients and working conditions remain a concern. When designing new hospitals, attention should be paid to optimal working conditions for nurses. To improve monitoring of patients, we recommend the use of remote-sensoring.

Mobility level and factors affecting mobility status in hospitalized patients admitted in single-occupancy patient rooms.

BACKGROUND: Although stimulating patients' mobility is considered a component of fundamental nursing care, approximately 35% of hospitalized patients experience functional decline during or after hospital admission. The aim of this study is to assess mobility level and to identify factors affecting mobility status in hospitalized patients admitted in single-occupancy patient rooms (SPRs) on general wards. METHODS: Mobility level was quantified with the Johns Hopkins Highest Level of Mobility Scale (JH-HLM) and EQ-5D-3L. GENEActiv accelerometer data over 24 h were collected in a subset of patients. Data were analyzed using generalized ordinal logistic regression analysis. The STROBE reporting checklist was applied. RESULTS: Wearing pajamas during daytime, having pain, admission in an isolation room, and wearing three or more medical equipment were negatively associated with mobilization level. More than half of patients (58.9%) who were able to mobilize according to the EQ-5D-3L did not achieve the highest possible level of mobility according to the JH-HLM. The subset of patients that wore an accelerometer spent most of the day in sedentary behavior (median 88.1%, IQR 85.9-93.6). The median total daily step count was 1326 (range 22-5362). CONCLUSION: We found that the majority of participating hospitalized patients staying in single-occupancy patient rooms were able to mobilize. It appeared, however, that most of the patients who are physically capable of walking, do not reach the highest possible level of mobility according to the JH-HLM scale. Nurses should take their responsibility to ensure that patients achieve the highest possible level of mobility.

Reference values of diaphragmatic dimensions in healthy children aged 0-8 years.

Diaphragmatic thickness (Tdi) and diaphragm thickening fraction (dTF) are widely used parameters in ultrasound studies of the diaphragm in mechanically ventilated children, but normal values for healthy children are scarce. We determined reference values of Tdi and dTF using ultrasound in healthy children aged 0-8 years old and assessed their reproducibility. In a prospective, observational cohort, Tdi and dTF were measured on ultrasound images across four age groups comprising at least 30 children per group: group 1 (0-6 months), group 2 (7 months-1 year), group 3 (2-4 years) and group 4 (5-8 years). Ultrasound images of 137 healthy children were included. Mean Tdi at inspiration was 2.07 (SD 0.40), 2.09 (SD 0.40), 1.69 (SD 0.30) and 1.72 (SD 0.30) mm for groups 1, 2, 3 and 4, respectively. Mean Tdi at expiration was 1.64 (SD 0.30), 1.67 (SD 0.30), 1.38 (SD 0.20) and 1.42 (SD 0.20) mm for groups 1, 2, 3 and 4, respectively. Mean Tdi at inspiration and mean Tdi at expiration for groups 1 and 2 were significantly greater than those for groups 3 and 4 (both p < 0.001). Mean dTF was 25.4% (SD 10.4), 25.2% (SD 8.3), 22.8% (SD 10.9) and 21.3% (SD 7.1) for group 1, 2, 3 and 4, respectively. The intraclass correlation coefficients (ICC) representing the level of inter-rater reliability between two examiners performing the ultrasounds was 0.996 (95% CI 0.982-0.999). ICC of the inter-rater reliability between the raters in 11 paired assessments was 0.989 (95% CI 0.973-0.995).   Conclusion: Ultrasound measurements of Tdi and dTF were highly reproducible in healthy children aged 0-8 years.    Trial registration: ClinicalTrials.gov identifier (NCT number): NCT04589910. What is Known: • Diaphragmatic thickness and diaphragm thickening fraction are widely used parameters in ultrasound studies of the diaphragm in mechanically ventilated children, but normal values for healthy children to compare these with are scarce. What is New: • We determined normal values of diaphragmatic thickness and diaphragm thickening fraction using ultrasound in 137 healthy children aged 0-8 years old. The diaphragmatic thickness of infants up to 1 year old was significantly greater than that of children from 2 to 8 years old. Diaphragmatic thickness decreased with an increase in body surface area. These normal values in healthy children can be used to assess changes in respiratory muscle thickness in mechanically ventilated children.

Prevalence and determinants of medication administration errors in clinical wards: A two-centre prospective observational study.

AIMS AND OBJECTIVES: To identify the prevalence and determinants of medication administration errors (MAEs). BACKGROUND: Insight into determinants of MAEs is necessary to identify interventions to prevent MAEs. DESIGN: A prospective observational study in two Dutch hospitals, a university and teaching hospital. METHODS: Data were collected by observation. The primary outcome was the proportion of administrations with one or more MAEs. Secondary outcomes were the type, severity and determinants of MAEs. Multivariable mixed-effects logistic regression analyses were used for determinant analysis. Reporting adheres to the STROBE guideline. RESULTS: MAEs occurred in 352 of 2576 medication administrations (13.7%). Of all MAEs (n = 380), the most prevalent types were omission (n = 87) and wrong medication handling (n = 75). Forty-five MAEs (11.8%) were potentially harmful. The pharmaceutical forms oral liquid (odds ratio [OR] 3.22, 95% confidence interval [CI] 1.43-7.25), infusion (OR 1.73, CI 1.02-2.94), injection (OR 3.52, CI 2.00-6.21), ointment (OR 10.78, CI 2.10-55.26), suppository/enema (OR 6.39, CI 1.13-36.03) and miscellaneous (OR 6.17, CI 1.90-20.04) were more prone to MAEs compared to oral solid. MAEs were more likely to occur when medication was administered between 10 a.m.-2 p.m. (OR 1.91, CI 1.06-3.46) and 6 p.m.-7 a.m. (OR 1.88, CI 1.00-3.52) compared to 7 a.m.-10 a.m. and when administered by staff with higher professional education compared to staff with secondary vocational education (OR 1.68, CI 1.03-2.74). MAEs were less likely to occur in the teaching hospital (OR 0.17, CI 0.08-0.33). Day of the week, patient-to-nurse ratio, interruptions and other nurse characteristics (degree, experience, employment type) were not associated with MAEs. CONCLUSIONS: This study identified a high MAE prevalence. Identified determinants suggest that focusing interventions on complex pharmaceutical forms and error-prone administration times may contribute to MAE reduction. RELEVANCE TO CLINICAL PRACTICE: The findings of this study can be used to develop targeted interventions to improve patient safety.

Quality improvement intervention to stimulate early mobilisation of critically ill children.

BACKGROUND: Immobility during hospital stay is associated with muscle weakness, delirium, and delayed neurocognitive recovery. Early mobilisation of critically ill adults improves their physical functioning and shortens the duration of mechanical ventilation. However, comparable research in children is lacking. AIMS: To determine the effects of the implementation of an early mobilisation (EM) program on mobility activities for critically ill children and to explore barriers and facilitators and clinical outcomes before and after implementation. STUDY DESIGN: A prospective single-centre before-and-after study. This study was conducted in a PICU of a large tertiary hospital. Children aged from 3 months to 18 years, with an expected stay of ≥3 days were eligible to participate. In the "before" phase, participants received usual care; in the "after" phase we implemented a multicomponent, multidisciplinary EM protocol. The primary outcome was a change in the process outcome "mobilisation activities". Secondary outcomes were PICU staff opinions on mobilisation (survey), safety, process measures, involvement of parents and physical therapist, and clinical outcomes (sedative use and prevalence of delirium). RESULTS: A total of 113 children were included; 55 before and 58 after, with a median age of 31 months (IQR: 10-103) and 35 months (IQR: 7-152), respectively. The number of mobilisation activities (per patient per day) had significantly increased from 5 (IQR: 2-7) to 6 (IQR: 4-8) (U = 272185.0; p < .001). PT consultations for mobilisation had significantly increased from 23.6% (13/55) to 46.5% (27/58) (X2  = 6.48; p = .011). In both phases, no mobilisation-related adverse events were documented. The survey showed that PICU staff found EM of critically ill children useful and feasible. In the after phase, PICU staff rated the perceived benefit of the support of the physical therapist during mobilisation activities significantly higher than in the before phase (X2  = 34.80; p < .001). CONCLUSIONS: Implementation of a structured EM program for critically ill children is feasible and safe. RELEVANCE TO CLINICAL PRACTICE: It is suggested to start the implementation of a structed EM program with the idendentification of local barriers and facilitators by an interdisciplinary PICU team. Further, an increased presence of physiotherapists on the PICU would improve mobilisation levels, and facilitate mobilisation in critically ill children. Also, they can support and advice PICU nurses and parents in mobilising children.

Implementation of a nursing oral health care protocol in a university teaching hospital: A cluster-randomized stepped-wedge design.

INTRODUCTION: Providing oral care is an essential part of basic nursing care but receives little priority in daily practice, with a risk of adverse events. Also, nurses report many barriers to adequate provision of oral care, such as time restraints, insufficient materials, fear of causing pain, lack of knowledge and a negative attitude towards providing oral care. METHODS: We performed a cluster-randomized, stepped-wedge study to explore the effect of the the implementation of a new nursing evidence-based oral care protocol on nurses' knowledge, attitude and protocol adherence. The study population included both nursing students, graduated nurses and patients in selected wards. The implementation strategy included oral and written information, instruction videos and reminders. Nurses' knowledge and attitude towards oral care were assessed at baseline and after the implementation of the protocol with a validated 47-item questionnaire with a score range of 0-100. Secondarily, nurses' protocol adherence to teeth brushing, measured in Activities of Daily Living (ADL) dependent patients, was evaluated. The Standards for Reporting Implementation Studies (StaRI) Statement was used. RESULTS: At baseline, the questionnaire was completed by 226 nurses; after implementation by 283. Knowledge had significantly improved from 68.8 to 72.3. Nurses' attitude improved not significantly. Protocol adherence was assessed in 73 ADL-dependent patients at baseline, in 51 after implementation. Adherence to teeth brushing significantly decreased in patients with permanent teeth. Also, adherence to both teeth brushing and usage of soap decreased in patients with (partial) dentures. CONCLUSION: Nurses' knowledge and attitude of oral care increased somewhat after the implementation of a new nursing evidence-based protocol. After implementation, there was an unexplained decreased adherence to oral care in ADL-dependent patients.

Quality of life of locally advanced pancreatic cancer patients after FOLFIRINOX treatment.

BACKGROUND: Quality of life in cancer patients might be affected by chemotherapy-induced toxicity. Especially in patients with pancreatic ductal adenocarcinoma (PDAC), with a short life expectancy, fear of poor quality of life is often a reason for both patients and medical oncologists to refrain from further treatment. In this study, we investigated quality of life (QoL), pain, sleep, and activity levels in locally advanced pancreatic cancer (LAPC) patients after FOLFIRINOX treatment. METHODS: A total of 41 LAPC patients with stable disease or partial response were included after completion of at least four cycles of FOLFIRINOX. QoL was measured with the EORTC QLQ-C30 and NRS pain scores. Patients completed the Richards-Campbell Sleep Questionnaire (RCSQ) for five consecutive nights and wore a GENEActiv tri-axial accelerometer (Actiwatch) for 7 days, registering sleep duration, efficiency, and activity. RESULTS: Mean EORTC QLQ-C30 score for global health status was 78.3 (± 17.3), higher than reference values for cancer patients (P < 0.001) and general population (P = 0.045). LAPC patients reported few disease-related symptoms. Two patients (5%) reported pain scores > 3. Mean sleep duration was 8 h/night (± 1.2 h) and sleep efficiency 70% (± 9%) with high patient-reported quality of sleep (mean RCSQ score 72.0 ± 11.4). Mean duration of moderate-vigorous activity was 37 min/week (± 103 min/week). CONCLUSIONS: QoL is very good in most LAPC patients with disease control after FOLFIRINOX, measured with validated questionnaires and Actiwatch registration. The fear of clinical deterioration after FOLFIRINOX is not substantiated by this study and should not be a reason to refrain from treatment. TRIAL REGISTRATION: Dutch trial register NL7578.

COVID-19 lockdown impacts the wellbeing of parents with infants on a Dutch neonatal intensive care unit.

PURPOSE: Parents of infants admitted to a neonatal intensive care unit (NICU) experience additional stress due to restrictions on their presence and visits by other family members during the COVID-19 pandemic. Our study aims to describe how this impacted parents and how NICU staff could support them. DESIGN AND METHODS: This was a cross-sectional study in which 25 parents (16 mothers, 9 fathers) of infants admitted to our NICU during the first COVID-19 lockdown completed online questionnaires with socio-demographic questions, the Parental Stressor Scale:NICU (PSS:NICU) and questions related to COVID-19. RESULTS: Being separated from, and not being able to hold their infant at all times were among the most important PSS:NICU stressors. Parents experienced additional stress because other family members were not allowed to visit. They indicated that NICU staff could support them by clearly explaining the reasons for visitor restrictions and by ensuring that they felt heard. Most parents supported the restrictions, but also mentioned that less strict measures would really help them. CONCLUSIONS: Parents who participated in this study found it very stressful that they could not be with their infant together with their partner and other family members. Furthermore, parents recommended the hospital management to continuously reconsider whether particular restrictions could be lifted in case of a new lockdown. Together with clear communication, this would result in less parenteral stress. PRACTICE IMPLICATIONS: Hospital management should be cautious on restricting the presence of parents and other family members and scale restrictions back whenever possible.

Development of a non-pharmacologic delirium management bundle in paediatric intensive care units.

BACKGROUND: Non-pharmacologic interventions might be effective to reduce the incidence of delirium in pediatric intensive care units (PICU). AIM: To explore expert opinions and generate informed consensus decisions regarding the content of a non-pharmacologic delirium bundle to manage delirium in PICU patients. STUDY DESIGN: A two-round online Delphi study was conducted from February to April 2021. PICU experts (nurses, physicians, researchers, physical therapists, play specialists, and occupational therapists) located in Europe, North America, South America, Asia, and Australia participated. RESULTS: We developed a questionnaire based on the outcomes of a comprehensive literature search in the domains: 1) cognition support; 2) sleep support; and 3) physical activity support. Under these domains, we listed 11 strategies to promote support with 61 interventions. Participants rated the feasibility of each intervention on a 9-point Likert scale (ranging from 1 strongly disagree to 9 strongly agree). A disagreement index and panel median were calculated to determine the level of agreement among experts. In the second round, participants reassessed the revised statements and ranked the interventions in each domain in order of importance for age groups: 0-2, 3-5, and 6-18 years of age. During the first Delphi round, 53 of 74 (72%) questionnaires were completed, and in the second round 45 of 74 (61%) were completed. Five of the highest ranked interventions across the age groups were: 1) developing a daily routine, 2) adjusting light exposure according to the time of day, 3) scheduling time for sleep, 4) providing eyeglasses and hearing aids if appropriate, 5) encouraging parental presence. CONCLUSIONS: Based on expert consensus, we developed an age-specific non-pharmacologic delirium bundle of interventions to manage delirium in PICU patients. RELEVANCE TO CLINICAL PRACTICE: An age-specific Non-Pharmacological Delirium bundle is now ready to be tested in the PICU and will hopefully reduce pediatric delirium.

Professional Assessment Tool for Team Improvement: An assessment tool for paediatric intensive care unit nurses' technical and nontechnical skills.

BACKGROUND: Cardiorespiratory arrests are rare in paediatric intensive care units, yet intensive care nurses must be able to initiate resuscitation before medical assistance is available. For resuscitation to be successful, instant decision-making, team communication, and the coordinating role of the first responsible nurse are crucial. In-house resuscitation training for nurses includes technical and nontechnical skills. OBJECTIVES: The aim of this study was to develop a valid, reliable, and feasible assessment instrument, called the Professional Assessment Tool for Team Improvement, for the first responsible nurse's technical and nontechnical skills. METHODS: Instrument development followed the COnsensus-based Standards for the selection of health Measurement Instruments guidelines and professionals' expertise. To establish content validity, experts reached consensus via group discussions about the content and the operationalisation of this team role. The instrument was tested using two resuscitation assessment scenarios. Inter-rater reliability was established by assessing 71 nurses in live scenario sessions and videotaped sessions, using intraclass correlation coefficients and Cohen's kappa. Internal consistency for the total instrument was established using Cronbach's alpha. Construct validity was assessed by examining the associations between raters' assessments and nurses' self-assessment scores. RESULTS: The final instrument included 12 items, divided into four categories: Team role, Teamwork and communication, Technical skills, and Reporting. Intraclass correlation coefficients were good in both live and videotaped sessions (0.78-0.87). Cronbach's alpha was stable around 0.84. Feasibility was approved (assessment time reduced by >30%). CONCLUSIONS: The Professional Assessment Tool for Team Improvement appears to be a promising valid and reliable instrument to assess both technical and nontechnical skills of the first responsible paediatric intensive care unit nurse. The ability of the instrument to detect change over time (i.e., improvement of skills after training) needs to be established.

Postoperative breakthrough pain in paediatric cardiac surgery not reduced by increased morphine concentrations.

BACKGROUND: Morphine is commonly used for postoperative analgesia in children. Here we studied the pharmacodynamics of morphine in children after cardiac surgery receiving protocolized morphine. METHODS: Data on morphine rescue requirements guided by validated pain scores in children (n = 35, 3-36 months) after cardiac surgery receiving morphine as loading dose (100 µg kg-1) with continuous infusion (40 µg kg-1 h-1) from a previous study on morphine pharmacokinetics were analysed using repeated time-to-event (RTTE) modelling. RESULTS: During the postoperative period (38 h (IQR 23-46)), 130 morphine rescue events (4 (IQR 1-5) per patient) mainly occurred in the first 24 h (107/130) at a median morphine concentration of 29.5 ng ml-1 (range 7-180 ng ml-1). In the RTTE model, the hazard of rescue morphine decreased over time (half-life 18 h; P < 0.001), while the hazard for rescue morphine (21.9% at 29.5 ng ml-1) increased at higher morphine concentrations (P < 0.001). CONCLUSIONS: In this study on protocolized morphine analgesia in children, rescue morphine was required at a wide range of morphine concentrations and further increase of the morphine concentration did not lead to a decrease in hazard. Future studies should focus on a multimodal approach using other opioids or other analgesics to treat breakthrough pain in children. IMPACT: In children receiving continuous morphine infusion, administration of rescue morphine is an indicator for insufficient effect or an event. Morphine rescue events were identified at a wide range of morphine concentrations upon a standardized pain protocol consisting of continuous morphine infusion and morphine as rescue boluses. The expected number of rescue morphine events was found to increase at higher morphine concentrations. Instead of exploring more aggressive morphine dosing, future research should focus on a multimodal approach to treat breakthrough pain in children.

Sedation With Midazolam After Cardiac Surgery in Children With and Without Down Syndrome: A Pharmacokinetic-Pharmacodynamic Study.

OBJECTIVES: To compare the pharmacokinetics and pharmacodynamics of IV midazolam after cardiac surgery between children with and without Down syndrome. DESIGN: Prospective, single-center observational trial. SETTING: PICU in a university-affiliated pediatric teaching hospital. PATIENTS: Twenty-one children with Down syndrome and 17 without, 3-36 months, scheduled for cardiac surgery with cardiopulmonary bypass. INTERVENTIONS: Postoperatively, nurses regularly assessed the children's pain and discomfort with the validated COMFORT-Behavioral scale and Numeric Rating Scale for pain. A loading dose of morphine (100 µg/kg) was administered after coming off bypass; thereafter, morphine infusion was commenced at 40 µg/kg/hr. Midazolam was started if COMFORT-Behavioral scale score of greater than 16 and Numeric Rating Scale score of less than 4 (suggestive of undersedation). Plasma midazolam and metabolite concentrations were measured for population pharmacokinetic- and pharmacodynamic analysis using nonlinear mixed effects modeling (NONMEM) (Version VI; GloboMax LLC, Hanover, MD) software. MEASUREMENTS AND MAIN RESULTS: Twenty-six children (72%) required midazolam postoperatively (15 with Down syndrome and 11 without; p = 1.00). Neither the cumulative midazolam dose (p = 0.61) nor the time elapsed before additional sedation was initiated (p = 0.71), statistically significantly differed between children with and without Down syndrome. Population pharmacokinetic and pharmacodynamics analysis revealed no statistically significant differences between the children with and without Down syndrome. Bodyweight was a significant covariate for the clearance of 1-OH-midazolam to 1-OH-glucuronide (p = 0.003). Pharmacodynamic analysis revealed a marginal effect of the midazolam concentration on the COMFORT-Behavioral score. CONCLUSIONS: The majority of children with and without Down syndrome required additional sedation after cardiac surgery. This pharmacokinetic and pharmacodynamic analysis does not provide evidence for different dosing of midazolam in children with Down syndrome after cardiac surgery.

Effect of automated unit dose dispensing with barcode scanning on medication administration errors: an uncontrolled before-and-after study.

BACKGROUND: Medication administration errors (MAEs) occur frequently in hospitals and may compromise patient safety. Preventive strategies are needed to reduce the risk of MAEs. OBJECTIVE: The primary aim of this study was to assess the effect of central automated unit dose dispensing with barcode-assisted medication administration on the prevalence of MAEs. Secondary aims were to assess the effect on the type and potential severity of MAEs. Furthermore, compliance with procedures regarding scanning of patient and medication barcodes and nursing staff satisfaction with the medication administration system were assessed. METHODS: We performed a prospective uncontrolled before-and-after study in six clinical wards in a Dutch university hospital from 2018 to 2020. MAE data were collected by observation. The primary outcome was the proportion of medication administrations with one or more MAEs. Secondary outcomes were the type and potential severity of MAEs, rates of compliance with patient identification and signing of administered medication by scanning and nursing staff satisfaction with the medication administration system. Multivariable mixed-effects logistic regression analyses were used for the primary outcome to adjust for confounding and for clustering on nurse and patient level. RESULTS: One or more MAEs occurred in 291 of 1490 administrations (19.5%) pre-intervention and in 258 of 1630 administrations (15.8%) post-intervention (adjusted odds ratio 0.70, 95% confidence interval 0.51-0.96). The rate of omission fell from 4.6% to 2.0% and of wrong dose from 3.8% to 2.1%, whereas rates of other MAE types were similar. The rate of potentially harmful MAEs fell from 3.0% (n = 44) to 0.3% (n = 5). The rates of compliance with scanning of patient and medication barcode post-intervention were 13.6% and 55.9%, respectively.The median overall satisfaction score of the nurses with the medication administration system on a 100-point scale was 70 (interquartile range 63-75, n = 193) pre-intervention and 70 (interquartile range 60-78, n = 145) post-intervention (P = 0.626, Mann-Whitney U test). CONCLUSION: The implementation of central automated unit dose dispensing with barcode-assisted medication administration was associated with a lower probability of MAEs, including potentially harmful errors, but more compliance with scanning procedures is needed. Nurses were moderately satisfied with the medication administration system, both before and after implementation. In conclusion, despite low compliance with scanning procedures, this study shows that this intervention contributes to the improvement of medication safety in hospitals.

Effectiveness of Simulation Training and Assessment of PICU Nurses' Resuscitation Skills: A Mixed Methods Study from the Netherlands.

PURPOSE: The quality of resuscitation and effective leadership are decisive for the outcome of a resuscitation. Nurses are usually the first responders upon cardiac arrest. Therefore, we started the "proficiency check" project, which aims to improve nurses' resuscitation and teamwork skills. This article describes the effectiveness of the proficiency check and nurses' experiences with it. DESIGN AND METHODS: This study was done among intensive care nurses working on a pediatric ICU (PICU) in the Netherlands. It was designed as a mixed-methods study combining a quantitative and a qualitative approach. Quantitative data were obtained through a pre-posttest comparison of nurses' resuscitation and teamwork skills, in a simulation setting. Qualitative data on nurses' experiences were collected through semi-structured individual interviews. RESULTS: Both resuscitation and teamwork skills improved significantly. In 39 nurses (32%), the improvement of both resuscitation and teamwork skills after the intervention was large (effect size >0.8). The experiences of nurses regarding the proficiency check were diverse: on the positive side, increased knowledge and confidence were reported, whereas negative experiences related, among other things, to stress and anxiety. CONCLUSIONS: Resuscitation and teamwork skills of PICU nurses can be enhanced by the 'proficiency check' studied here. This simulation-based training can be further improved by incorporating the nurses' experiences. PRACTICE IMPLICATIONS: A simulation-based assessment for resuscitation may play an important role in a PICU, and possibly for other skills and in other settings as well. Particular attention should be paid to the stress that many nurses experience due to skills assessment.

Measuring process indicators and adverse events to assess the quality of care for inpatients with psychosis.

BACKGROUND: Research into the quality of care in psychiatry is scarce. Data collection is falling behind that for other fields of medicine and therefore the opportunity to improve care is missed. AIMS: In this medical record study we aim to determine: (i) whether or not patients' physical health indicators are assessed and pharmacological and behavioural treatment interventions applied; (ii) the incidence and nature of adverse events in psychotic inpatients. METHODS: Medical records of inpatients with psychosis admitted to psychiatric wards at Amsterdam UMC, location AMC, Department of psychiatry, were screened with a previously developed and tested two-step patient safety tool. RESULTS: Data of 299 admissions were included. Physical health indicators were not assessed in one-third of cases. Fifty-five percent of the patients were smokers but only 1% received an intervention. The family was actively involved in 43% of the cases. During 11,403 admission days, 235 adverse events had been recorded. The most frequent adverse event was adverse drug reactions (40%), which were mostly related to antipsychotic medication. CONCLUSIONS: In conclusion, quality of care auditing is useful to prioritize areas that need improvement. Future research should focus on interventions to improve the quality of psychiatric care.

Feasibility of Dried Blood Spots in Children with Behavioral Problems.

BACKGROUND: Minimally invasive sampling methods are important to facilitate therapeutic drug monitoring and pharmacokinetic research in children with behavioral problems. This study assessed the feasibility and pain of dried blood spot (DBS) sampling in this population. METHODS: Repeated DBS sampling was performed in children with autism spectrum disorder (ASD) and severe behavioral problems using antipsychotic drugs, aged between 6 and 18 years. The child, guardian, and DBS performer assessed pain using the numeric rating scale (NRS-11) or 5-face Faces Pain Scale. The influence of age, sex, and the fingerprick performer on the child's pain intensity was analyzed using linear mixed models. RESULTS: Overall, 247 fingerpricks were performed in 70 children. Seven children refused all DBS sampling. The median (interquartile range) NRS-11 pain scores were 2 (3) rated by children, 3 (2.5) by guardians, and 2 (2) by fingerprick performers. The child's age and sex, and fingerprick performer had no significant influence on pain intensity. CONCLUSIONS: DBS sampling could be performed in most children with ASD and severe behavioral problems. However, 1 in 5 children refused one or more DBS fingerpricks owing to distress. Most expressed minimal pain (NRS < 4). Repeated sampling with DBS is feasible in children with ASD and severe behavioral problems.

Music Interventions in Pediatric Surgery (The Music Under Surgery In Children Study): A Randomized Clinical Trial.

BACKGROUND: Perioperative music interventions have been shown to reduce anxiety and pain in adults. This inexpensive, easily applicable intervention could be of benefit to children as well. Our objective was to determine the effects of music interventions on distress, anxiety, and postoperative pain in infants undergoing surgery. METHODS: The Music Under Surgery In Children study was designed as a parallel, single-blind, randomized controlled trial with an a priori formulated hypothesis. Data were collected between August 2015 and October 2016 in a single tertiary care children's hospital. There was a 24-hour follow-up with blind primary outcome assessment. A random sample of 432 eligible 0-3 years of age infants admitted for orchidopexy, hypospadias, or inguinal hernia repair receiving general anesthesia and caudal block were asked for participation. Subjects were assigned to a preoperative music intervention, pre- and intraoperative music intervention, or no music intervention (control) via random allocation using a computer-generated list with the use of opaque envelopes. The main outcome measure was the postoperative level of distress assessed with the COMFORT-Behavior scale, which is an observational scale; furthermore, preoperative level of distress, preoperative anxiety, and physiological measurements such as heart rate (HR) and blood pressure were measured. The trial was registered at the Dutch Trial Register, number NTR5402 (www.trialregister.nl). RESULTS: One hundred ninety-five infants with median age 6.9 months (interquartile range, 3.3-11.1) were randomized, 178 of whom were included in the primary analysis. A nonsignificant difference in COMFORT-Behavior scale scores between the pre- and intraoperative music intervention group and control group at 4 hours after surgery was found (mean difference, -1.22; 95% CI, 2.60-0.17; P = .085). Additional analysis showed weak nonsignificant evidence for an interaction effect between music exposure and COMFORT-Behavior score at baseline (P = .027 with a Bonferroni-adjusted significance level of .025). General linear modeling showed a statistically significantly reduced HR after the preoperative music intervention in the holding area in the combined preoperative music intervention and intraoperative music intervention group compared to the control group (P = .003). The differences in HR among the 3 study arms at all time points were not statistically significant (P = .069). CONCLUSIONS: Music interventions do not seem to benefit all young infants undergoing surgery. The potential benefits of music interventions in the preoperative period and in more distressed children warrant further exploration.

Perspectives of patients, relatives and nurses on rooming-in for adult patients: A scoping review of the literature.

AIM: To explore the perspectives of patients, their relatives and nurses on rooming-in for adult patients. BACKGROUND: The practice of having family stay overnight with an adult patient in hospital is quite new. To support rooming-in programs, the perspectives from all stakeholders should be taken into account. METHODS: All types of studies on rooming-in in adult healthcare settings were included in this scoping review. Rooming-in has been defined as the practice where 'family members or trusted others are facilitated to continuously stay with the patient and are provided with facilities to sleep in the patient's room'. RESULTS: Seven studies were included: one randomized controlled trial, three qualitative studies, and three correspondence articles. Generally, patients felt safe in the presence of a family member, but could also feel restricted in their freedom and privacy. Family members saw a benefit for the patient, considered rooming-in a moral duty, and were happy to help. Nonetheless, family members reported rooming-in as physically and emotionally stressful. Nurses described that patients were less anxious and more easily adjusted to the hospital environment. CONCLUSIONS: The reviewed studies suggest that patients, family members, and nurses have both positive and negative experiences with rooming-in. The concept of rooming-in varies from continuous presence and involvement of relatives to one overnight stay in the patient's room. Each interpretation has its own implications for policy, design, guidelines and feasibility of rooming-in. Nursing staff should be included in decision-making processes for this practice.