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A previously healthy boy of preschool age was brought to the emergency department by ambulance with respiratory distress following the accidental inhalation of food contact dust (cake decorating powder). Prehospital oxygen saturations were 80% in room air. Initial treatment was with oxygen, nebulised salbutamol, oral dexamethasone and intravenous amoxicillin/clavulanic acid. Treatment was escalated to nasal high flow oxygen therapy and high dependency care within 8 hours. Lung fields on his initial chest X-ray were clear but the following day showed perihilar infiltrates extending into the lower zones in keeping with inflammation. He was treated with intravenous methylprednisolone, followed by a weaning dose of oral prednisolone over 14 days.He required oxygen therapy for 9 days and remained in hospital for 11 days. Outpatient follow-up, 24 days after the inhalation took place was reassuring with the child showing no signs of abnormal respiratory symptoms.

Background: Torus (buckle) fractures of the wrist are the most common fractures in children, involving the distal radius and/or ulna. It is unclear if children require rigid immobilisation and follow-up, or would equally recover by being discharged without any immobilisation or a bandage. Given the large number of these injuries, identifying the optimal treatment strategy could have important effects on the child, school absences and NHS costs. Objectives: To establish whether treating children with a distal radius torus fracture with the offer of a soft bandage and immediate discharge (“offer of bandage”), provides the same recovery, in terms of pain, function, complications, acceptability, school absence and resource use, as treatment with rigid immobilisation and follow-up as per usual practice (“rigid immobilisation”). Design: A pragmatic, multicentre, randomised controlled equivalence trial. Setting: 23 UK Emergency Departments. Participants: 965 children (4-15 years) with a distal radius torus fracture were randomised from January 2019 to July 2020 using a secure, centralised, online encrypted randomisation service. Exclusion criteria included presentation >36 hours after injury, multiple injuries and inability to complete follow-up. Interventions: Offer of bandage (n= 489) of whom the bandage was applied in 458, versus rigid immobilisation (n= 476). Participants and clinicians were not blinded to the treatment allocation. Main outcome measures: Pain at 3-days post-randomisation measured using the WongBaker FACES Pain Rating Scale. Secondary outcomes were the PROMIS Upper Extremity score for children, health related quality of life (QoL), complications, school absence, analgesia use and resource use collected up to 6 weeks post-randomisation. Results: 94% of participants provided primary outcome data. Pain was equivalent at the 3 day primary outcome for both groups. With reference to the pre-specified equivalence margin of 1.0, the adjusted difference in the intention-to-treat population was -0.10; 95% CI -0.37 to 0.17 and the per-protocol population was -0.06; 95% CI -0.34 to 0.21. There was equivalence in pain for both age subgroups (4-7 and 8–15 years). There was no difference in the rate of complications, with five (1.0%) in the offer of bandage group and three (0.6%) in the rigid immobilisation group. There were no differences between treatment groups in functional recovery, QoL or school absence at any point during follow-up. Analgesia use was marginally higher at Day 1 in the offer of bandage group (83% vs 78% participants), though was no different at other times. The offer of bandage significantly reduced the cost of treatment, and had a high probability of cost-effectiveness. Limitations: Families had a strong pre-existing preference for rigid immobilisation. Given this, and the inability to blind families to the treatment allocation, observer bias was a concern. However, there was clear evidence of equivalence. Conclusions: The study findings support the offer of bandage in children with a distal radius torus fracture.

BACKGROUND Dental attendances to paediatric emergency departments (PEDs) represent suboptimal use of resources of an unknown scale. AIM To evaluate dental attendances at two PEDs in the UK and compare traumatic dental injury (TDI) and non-traumatic dental conditions (NTDCs). DESIGN Retrospective data were collected for a 12-month period including demographics, attendance pattern, assessment, and management. Maxillofacial conditions were excluded, and attendances were grouped as TDI and NTDC. RESULTS Of 667 attendances, 35.1% (n = 234) were TDI and 64.9% (n = 433) NTDC. Nineteen children reattended. Proportionately, more TDI attenders were male, White British, of lower mean age, and resided in less deprived areas than NTDCs. Over half (52.3%, n = 339) of attendees resided in the 10% most deprived UK areas. Saturday and Monday were modal attendance days; attendance peaked in summer. Over half (56.4%, n = 376) attended out of hours. A majority (74.8%, n = 499) self-referred and half accessed no other service prior to PED attendance. No PED dental input was received for 38.7% (n = 258), and dental treatment was received for 12.4% (n = 83). Antibiotics were provided for 42.1% (n = 281), and 15.4% (n = 103) were admitted. CONCLUSION Dental abscesses and toothache accounted for half of attendances, many of these children may be managed in primary care. Improved signposting to alternative dental services for non-urgent conditions may better allocate resources to those with urgent need.

Study objectiveApproximately 250,000 children undergo pediatric procedural sedation (PPS) in UK & Irish emergency departments (ED) annually. PPS practice in our setting has not been described as fully as in other high income countries. We aimed to evaluate PPS in UK and Irish EDs.MethodsOnline survey distributed through Pediatric Emergency Research in the UK and Ireland (PERUKI) during June 2020. One respondent per ED completed the survey, including questions on agents, fasting, training and governance. Results are presented using descriptive statistics.Results61/72 (85%) sites responded, of which PPS was performed in 50 (82%). Intravenous ketamine was the most common agent (43/50; 86%), followed by variable concentration nitrous oxide (13/50; 26%). Fasting practices varied widely across sites and agents: 24/45 (53.3%) of sites delivering ketamine/es-ketamine PPS required fasting compared to 2/13 (15.4%) before variable concentration nitrous oxide. 49/72 (68.1%) provided complete responses on training; internal training packages existed in under half (22/49, 44.9%). Most had a guideline (43/61; 70.5%) and documentation proforma (39/61; 63.9%). Databases existed in 24/61 (39.3%).ConclusionWe have demonstrated widespread PPS use, but non-standardized practice. This leads to potential issues of risk and variability, highlighting a need for a UK and Ireland sedation package to standardize PPS practice and data collection, informed by international guidance and evidence. We propose development of a prospective ED sedation registry to facilitate data collection to support research within this area.

Convulsive status epilepticus (CSE) is the most common neurological emergency in children and the second most common neurological emergency in adults. Mortality is low, but morbidity, including neuro-disability, learning difficulties, and a de-novo epilepsy, may be as high as 22%. The longer the duration of CSE, the more difficult it is to terminate, and the greater the risk of morbidity. Convulsive status epilepticus is usually managed using specific national or local algorithms. The first-line treatment is administered when a tonic-clonic or focal motor clonic seizure has lasted five minutes (impending or premonitory CSE). Second-line treatment is administered when the CSE has persisted after two doses of a first-line treatment (established CSE). Randomised clinical trial (RCT) evidence supports the use of benzodiazepines as a first-line treatment of which the most common are buccal or intra-nasal midazolam, rectal diazepam and intravenous lorazepam. Alternative drugs, for which there are considerably less RCT data, are intra-muscular midazolam and intravenous clonazepam. Up until 2019, phenobarbital and phenytoin (or fosphenytoin) were the preferred second-line treatments but with no good supporting RCT evidence. Robust RCT data are now available which has provided important information on second-line treatments, specifically phenytoin (or fosphenytoin), levetiracetam and sodium valproate. Lacosamide is an alternative second-line treatment but with no supporting RCT evidence. Current evidence indicates that first, buccal or intranasal midazolam or intravenous lorazepam are the most effective and the most patient and carer-friendly first-line anti-seizure medications to treat impending or premonitory CSE and second, that there is no difference in efficacy between levetiracetam, phenytoin (or fosphenytoin) or sodium valproate for the treatment of established CSE. Pragmatically, levetiracetam or sodium valproate are preferred to phenytoin (or fosphenytoin) because of their ease of administration and lack of serious adverse side-effects, including potentially fatal cardiac arrhythmias. Sodium valproate must be used with caution in children aged three and under because of the rare risk of hepatotoxicity and particularly if there is an underlying mitochondrial disorder.

Background With increasing wait times seen across Emergency Departments in recent years, it is vital to have a reliable triage system in place. Newborns represent a particularly high-risk group. They often have nonspecific presentations for serious underlying illness and a tendency toward rapid clinical deterioration. A range of benign clinical findings specific to this age group may also pose a diagnostic challenge. Despite these nuances, the triage tools used to assign clinical priority in older children and adults continue to be applied in the neonatal population. Objectives To review all neonatal attendances to a Paediatric Emergency Department (PED) during the months of September 2019 (pre-COVID-19) and April 2020 (COVID-19 era) with the aim of determining if triage assignments and outcomes for newborn patients correlate with their disposition and if new trends are apparent due to the pandemic. Methods The PED is based in a tertiary paediatric hospital in the UK which utilizes the Manchester Triage System (MTS) adapted for neonates to triage this particular group of patients. The electronic case notes for each patient were reviewed noting their age, presenting complaint, assigned MTS triage category and discharging diagnosis. Outcomes evaluated included the need for diagnostic testing, treatment and admission. The relationship between assigned triage categories and outcomes was then reviewed. Results 179 neonates presented in September 2019 compared to 79 in April 2020, (3.4% of monthly PED attendances for Sept 2019 vs 3.8% for April 2020); 43% of these patients were Conclusions Trends across the triage categories demonstrate that the more urgent the triage category assigned, the more likely investigations and admission to hospital are. This is demonstrated in both months audited pre COVID-19 and during the pandemic. There is less of a hospitalization difference in those triaged urgent and standard. In these categories we see more variation in diagnosis and disposition, reflecting a more heterogenous group of well babies mixed in with babies requiring further investigations, treatment and admission. It is this group that pose the diagnostic challenge and raise concerns about the suitability of the triage system in identifying clinical priority. Further work needs to focus on examining the suitability of this triage model in the neonatal group to understand if there are more robust diagnostic clinical indicators of illness that can be determined at triage.

BackgroundMusic is known to have therapeutic benefits and is frequently used in healthcare. For children in emergency settings, it may reduce stress and pain. There is little evidence evaluating the effect of live music in an emergency setting. This innovative study explores the effect of live music on children undergoing a painful procedure in a Paediatric Emergency Department (PED).ObjectivesWhether live music helps to decrease pain and distress in children undergoing a painful procedure in the PED.Whether these procedures can be carried out with greater ease from a clinician’s perspective and whether staff experience is impacted by the presence of live music.Overall impact on the PED experience from the patients, families and clinicians’ perspectives.MethodsA mixed methods study, designed with input from the local Young Persons Advisory Group (YPAG). Patients between 6 months - 16 years of age undergoing a painful procedure (eg cannulation) in PED were recruited after written consent. All patients received ‘standard’ distraction techniques and appropriate analgesia eg Ametop. The intervention group received live music (Musicians playing clarinet & guitar) within the cubicle whilst they underwent the procedure and the control group no live music. Data on physiological measures (Heart rate), self-reported pain (Wong-Baker Faces scale >3years of age) & observed pain (FLACC Scale in younger children) were collected in real time by an independent observer. Following the procedure parents, children & clinicians completed a written questionnaire. Questions included ‘How did you feel the music affected the child’s distress before, during & after the procedure’ and ‘Can you tell me about how the live music helped or hindered the procedure’.Results110 participants were included in the study. Qualitative responses were overwhelmingly positive, but quantitative results showed no significant positive interaction between music and reduced pain and distress. Qualitative data indicated that live music in an ED setting is reported to make children, parents and staff feel more at ease, creating distraction and change of focus for children undergoing procedures and enhancing wellbeing in the department. Quotes included: ‘Thumbs up and special, I was a little bit worried but the music made me happy. I was really brave’ (Child). ‘My experience today has been positive, I believe the music is beneficial to the children during stressful times’ (Parent). ‘I think it makes the A&E department a more pleasant environment. Children and staff love it’(Clinician).ConclusionsA ground-breaking study of this nature looking at the effect of live music on children undergoing painful procedures is possible in a busy PED. The qualitative data is overwhelmingly positive and indicates across all groups that live music is beneficial to children, parents and clinicians. COVID-19 has brought further challenges for musicians working within the healthcare setting but this study shows the positive value of their work in an acute clinical environment and that research in this area is vital to patient and staff wellbeing.

BackgroundAlternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the ‘Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children’ (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC.MethodsQualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner–parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe et al (2016) model for recruitment to trials.ResultsWe analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC.ConclusionThis study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.

Aims This study sought to estimate the clinical outcomes and describe the nationwide variation in practice, as part of the feasibility workup for a National Institute for Health and Care Excellence (NICE) recommended randomized clinical trial to determine the optimal treatment of torus fractures of the distal radius in children. Methods Prospective data collection on torus fractures presenting to our emergency department. Patient consent and study information, including a copy of the Wong-Baker Faces pain score, was issued at the first patient contact. An automated text message service recorded pain scores at days 0, 3, 7, 21, and 42 postinjury. A cross-sectional survey of current accident and emergency practice in the UK was also undertaken to gauge current practice following the publication of NICE guidance. Results In all, 30 patients with a mean age of 8.9 years were enrolled over a six-week period. Of the 150 potential data points, data was captured in 146, making the data 97.3% complete. Pain scores were recorded at day 0 (mean 6.5 (95% confidence interval (CI) 5.7 to 7.3)), day 3 (4.4 (95% CI 3.5 to 5.2)), day 7 (3.0 (95% CI 2.3 to 3.6)), day 21 (1.2 (95% CI 0.7 to 1.7)) and day 42 (0.4 (95% CI 0.1 to 0.7)). Of the 100 units who participated in the nationwide survey, 38% were unaware of any local or national protocols regarding torus fractures, 41% treated torus fractures with cast immobilization, and over 60% of patients had follow-up arranged, both contradictory to national guidelines. Conclusion We have demonstrated the severity, recovery trajectory, and variation in pain scores among children with torus fractures. We demonstrate excellent follow-up of patient outcomes using text messages. Despite national guidelines, there is significant variation in practice. This data directly informed the development of an ongoing nationwide randomized clinical trial – the FORearm Fracture Recovery in Children Evaluation (FORCE) study.

What you need to know Torus (buckle) fractures are the most common fractures of the wrist in children, involving the distal radius and/or ulna bone (fig 1).1 They typically occur in children up to age 14, usually after a low energy fall.2 The flexibility of immature bone in children enables force to be absorbed as with the “crumple zone” of a car: crushing—or buckling—as it is injured. Such fractures differ from greenstick fractures, in which the bone bends (rather than crushes), resulting in a complete break in one cortex and a bend on the opposite side (akin to snapping a fresh twig from a tree). Torus fractures result in a mild deformity without a break in the bone surface, and pain is the main clinical feature. The child may need assistance with schoolwork, time off physical activities, and help with self-care during the recovery period. Fig 1 Anteroposterior (a) and lateral (b) radiographs of the wrist showing a torus fracture of the distal radius and ulna with compression of the bones dorsally, though no break in the bone surface Parents typically expect that any fracture needs plaster cast immobilisation to ensure adequate healing. However, torus fractures heal quickly, with pain almost completely resolved three weeks after …

Aims Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221.

Background Convulsive status epilepticus is the most common neurological emergency in children. Its management is important to avoid or minimise neurological morbidity and death. The current first-choice second-line drug is phenytoin (Epanutin, Pfizer Inc., New York, NY, USA), for which there is no robust scientific evidence. Objective To determine whether phenytoin or levetiracetam (Keppra, UCB Pharma, Brussels, Belgium) is the more clinically effective intravenous second-line treatment of paediatric convulsive status epilepticus and to help better inform its management. Design A multicentre parallel-group randomised open-label superiority trial with a nested mixed-method study to assess recruitment and research without prior consent. Setting Participants were recruited from 30 paediatric emergency departments in the UK. Participants Participants aged 6 months to 17 years 11 months, who were presenting with convulsive status epilepticus and were failing to respond to first-line treatment. Interventions Intravenous levetiracetam (40 mg/kg) or intravenous phenytoin (20 mg/kg). Main outcome measures Primary outcome – time from randomisation to cessation of all visible signs of convulsive status epilepticus. Secondary outcomes – further anticonvulsants to manage the convulsive status epilepticus after the initial agent, the need for rapid sequence induction owing to ongoing convulsive status epilepticus, admission to critical care and serious adverse reactions. Results Between 17 July 2015 and 7 April 2018, 286 participants were randomised, treated and consented. A total of 152 participants were allocated to receive levetiracetam and 134 participants to receive phenytoin. Convulsive status epilepticus was terminated in 106 (70%) participants who were allocated to levetiracetam and 86 (64%) participants who were allocated to phenytoin. Median time from randomisation to convulsive status epilepticus cessation was 35 (interquartile range 20–not assessable) minutes in the levetiracetam group and 45 (interquartile range 24–not assessable) minutes in the phenytoin group (hazard ratio 1.20, 95% confidence interval 0.91 to 1.60; p = 0.2). Results were robust to prespecified sensitivity analyses, including time from treatment commencement to convulsive status epilepticus termination and competing risks. One phenytoin-treated participant experienced serious adverse reactions. Limitations First, this was an open-label trial. A blinded design was considered too complex, in part because of the markedly different infusion rates of the two drugs. Second, there was subjectivity in the assessment of ‘cessation of all signs of continuous, rhythmic clonic activity’ as the primary outcome, rather than fixed time points to assess convulsive status epilepticus termination. However, site training included simulated demonstration of seizure cessation. Third, the time point of randomisation resulted in convulsive status epilepticus termination prior to administration of trial treatment in some cases. This affected both treatment arms equally and had been prespecified at the design stage. Last, safety measures were a secondary outcome, but the trial was not powered to demonstrate difference in serious adverse reactions between treatment groups. Conclusions Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions. The results suggest that it may be an alternative to phenytoin in the second-line management of paediatric convulsive status epilepticus. Simple trial design, bespoke site training and effective leadership were found to facilitate practitioner commitment to the trial and its success. We provide a framework to optimise recruitment discussions in paediatric emergency medicine trials. Future work Future work should include a meta-analysis of published studies and the possible sequential use of levetiracetam and phenytoin or sodium valproate in the second-line treatment of paediatric convulsive status epilepticus. Trial registration Current Controlled Trials ISRCTN22567894 and European Clinical Trials Database EudraCT number 2014-002188-13. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 58. See the NIHR Journals Library website for further project information.

Aims/Objectives/BackgroundApproximately 250,000 children undergo paediatric procedural sedation (PPS) in UK and Irish emergency departments (ED) annually. In comparison to other countries, PPS practice in our setting has not been described. We therefore aimed to evaluate PPS practice in UK and Irish EDs.Methods/DesignOnline survey distributed through Paediatric Emergency Research in the UK and Ireland (PERUKI) during June 2020. One respondent per ED completed the survey, including questions on indications, agents, staffing and governance. Results are presented using descriptive statistics.Results/Conclusions61/72 (85%) sites responded, of which PPS was performed in 50 (82.0%). Intravenous ketamine was the most common agent (43/50; 86%), followed by fixed concentration nitrous oxide (FCNO, 35/50; 70%), and variable concentration nitrous oxide (VCNO, 13/50; 26%). PPS was mostly performed a few times a week (17/50; 34%) or daily (9/50; 18%). The most frequent indications were wound closure (31/50; 62%), orthopaedic reduction (28/61; 56%) and foreign body removal (17/61; 34%). Required sedationist seniority was highest for propofol and ketamine/es-ketamine (requiring consultant, registrar, or ANP), whilst FCNO was widely delivered by nurses and SHOs. Most sites had a guideline (43/61; 70.5%), documentation proforma (39/61; 63.9%) and equipment (36/61; 59.0%) and patient checklists (41/50; 82%). Explicit discharge criteria were required for ketamine/es-ketamine (40/45; 88.9%), midazolam (9/10; 90%), propofol (7/10; 70%) and VCNO (9/13; 69.2%). Databases existed in 24/61 (39.3%).We have demonstrated wide PPS use, but non-standardised practice, with only two-thirds of sites using a PPS guideline and standardised proforma. This leads to potential issues of risk and variability, highlighting a need for a UK and Ireland sedation package to standardise PPS practice and data collection, informed by international guidance and evidence. We propose development of a prospective ED sedation registry to facilitate data collection to support research within this area.

BackgroundKey challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials.MethodsA mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate.ResultsA total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target.ConclusionsSuccessful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.

Background: In some infants with bronchiolitis High-Flow Nasal Cannula (HFNC) oxygen therapy fails and other respiratory support is needed. Aim: Systematically review evidence around prognostic factors associated with HFNC failure in bronchiolitis. Methods: We included observational studies of infants Results: We included 13 studies (6/13 multicentre, 7/13 observational [6/7 retrospective]), involving 3,114 infants (85% had bronchiolitis). Studies were of reasonable quality, but considerable heterogeneity and low generalisability rendered overall quality of evidence very low. Reporting of methods, analysis and results were often inadequate. No infant characteristics (age/weight/comorbidity; 10 studies), or clinical observations/severity scores (6 studies) consistently predicted HFNC failure. When reported, markers of respiratory acidosis at HFNC initiation more consistently demonstrated statistically significant association with treatment failure (pH in 4/5 studies; pCO2 in 3/5 studies). Conclusion: No factors consistently predict failure of HFNC in bronchiolitis, but the quality of the evidence is very low. Respiratory acidosis may predict treatment failure but should be tested in prospective multicentre studies before being used to select respiratory support modalities for individual infants with bronchiolitis.

Background: Benefits of oral corticosteroids (OCS) for acute preschool wheeze are unclear. Aim: Systematically review evidence for OCS in preschool children presenting to the emergency department (ED) or hospitalised with acute wheeze. Methods: We included randomised controlled trials of OCS vs placebo for children Results: Four studies were eligible. Risk of bias was generally low except for selective outcome reporting. OCS did not reduce risk of hospitalisation (Risk ratio 0.94,95%CI 0.80,1.12; Figure 1). Of 3 studies reporting LOS, 2 showed statistically but not clinically significant reduction (placebo 9 hours [IQR 2-16] vs OCS 6.2 [2–11.8] p0.04; and placebo 7.7 hours[5.0-22.9] versus OCS 6.8[4–14] p0.03). Atopic history, and interval symptoms were not consistently associated with better response to OCS. Severity and prior diagnosis of asthma were associated with response in one study. Conclusion: High quality evidence suggests OCS should not be used in the ED in acute preschool wheeze. Effects on those with known asthma or hospitalised with severe illness are uncertain.

Aims Challenges to the success of ‘The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE)’ trial included: practitioner anxieties about research without prior consent (‘deferred consent’), including how parents would react to being informed their child had already been randomised into the trial; inexperience in conducting an Emergency Department led trial in a paediatric neurological emergency; and use of an anti-epileptic medication (Levetiracetam), which was not the standard medication in this clinical setting. This was a nested study within EcLiPSE that aimed to explore parent and practitioner experiences to inform trial recruitment and conduct. Methods A mixed method study involving interviews, focus groups and questionnaires with EcLiPSE practitioners and questionnaires and interviews with parents of randomised children. Qualitative data were anonymised and analysed thematically. Quantitative data were cleaned and analysed using descriptive statistics and chi-square test for trend. We present key themes identified from data synthesis. Results One hundred and forty three parents (93 mothers, 39 fathers, 11 missing parent information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups and 199 (117 medical, 78 nursing, 3 ‘other’) completed a questionnaire in the final phase of EcLiPSE. Practitioners highly valued bespoke site training, a clinically important research question and simple trial design. These factors, alongside recruitment experience and leadership, were found to facilitate practitioner ‘buy in’, commitment and ultimately, trial success. Parents supported the trial and understood why consent had been sought after treatment had been given. EcLiPSE was completed on time, achieving its recruitment target. Conclusions Our study provides valuable insight into factors that helped to facilitate successful conduct and recruitment to a challenging emergency department led trial. The results will hopefully facilitate future research in paediatric emergency departments.

Background EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents’ perspectives and research without prior consent (RWPC) guidance, we developed an interactive training package (including videos, simulation and question and answer sessions) and evaluated its dissemination and impact upon on practitioners’ confidence in recruitment and consent. Methods Questionnaires were administered before and immediately after training followed by telephone interviews (mean 11 months later), focus groups (mean 14 months later) and an online questionnaire (8 months before trial closure). Results One hundred and twenty-five practitioners from 26/30 (87%) participating hospitals completed a questionnaire before and after training. We conducted 10 interviews and six focus groups (comprising 36 practitioners); 199 practitioners working in all recruiting hospitals completed the online questionnaire. Before training, practitioners were concerned about recruitment and consent. Confidence increased after training for explaining (all scale 0–5, 95% CIs above 0 and p values

Site initiation visit (SIV) questionnaire. (DOCX 647 kb)

Example telephone interviews and focus group topic guide questions related to site visit training. (DOCX 18 kb)

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOCX 60 kb)

Objective To inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process. Design Qualitative interview and focus group study. Setting 8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care. Participants 17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE. Results Most parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information. Conclusions Our study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making.