Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures.

BACKGROUND: Data on whether ultrasonography for the initial diagnostic imaging of forearm fractures in children and adolescents is noninferior to radiography for subsequent physical function of the arm are limited. METHODS: In this open-label, multicenter, noninferiority, randomized trial in Australia, we recruited participants 5 to 15 years of age who presented to the emergency department with an isolated distal forearm injury, without a clinically visible deformity, in whom further evaluation with imaging was indicated. Participants were randomly assigned to initially undergo point-of-care ultrasonography or radiography, and were then followed for 8 weeks. The primary outcome was physical function of the affected arm at 4 weeks as assessed with the use of the validated Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) score (range, 8 to 40, with higher scores indicating better function); the noninferiority margin was 5 points. RESULTS: A total of 270 participants were enrolled, with outcomes for 262 participants (97%) available at 4 weeks (with a window of ±3 days) as prespecified. PROMIS scores at 4 weeks in the ultrasonography group were noninferior to those in the radiography group (mean, 36.4 and 36.3 points, respectively; mean difference, 0.1 point; 95% confidence interval [CI], -1.3 to 1.4). Intention-to-treat analyses (in 266 participants with primary outcome data recorded at any time) produced similar results (mean difference, 0.1 point; 95% CI, -1.3 to 1.4). No clinically important fractures were missed, and there were no between-group differences in the occurrence of adverse events. CONCLUSIONS: In children and adolescents with a distal forearm injury, the use of ultrasonography as the initial diagnostic imaging method was noninferior to radiography with regard to the outcome of physical function of the arm at 4 weeks. (Funded by the Emergency Medicine Foundation and others; BUCKLED Australian New Zealand Clinical Trials Registry number, ACTRN12620000637943).

Resuscitation With Early Adrenaline Infusion for Children With Septic Shock: A Randomized Pilot Trial.

OBJECTIVES: In children with septic shock, guidelines recommend resuscitation with 40-60 mL/kg of fluid boluses, yet there is a lack of evidence to support this practice. We aimed to determine the feasibility of a randomized trial comparing early adrenaline infusion with standard fluid resuscitation in children with septic shock. DESIGN: Open-label parallel randomized controlled, multicenter pilot study. The primary end point was feasibility; the exploratory clinical endpoint was survival free of organ dysfunction by 28 days. SETTING: Four pediatric Emergency Departments in Queensland, Australia. PATIENTS: Children between 28 days and 18 years old with septic shock. INTERVENTIONS: Patients were assigned 1:1 to receive a continuous adrenaline infusion after 20 mL/kg fluid bolus resuscitation (n = 17), or standard care fluid resuscitation defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to inotrope commencement (n = 23). MEASUREMENTS AND MAIN RESULTS: Forty of 58 eligible patients (69%) were consented with a median age of 3.7 years (interquartile range [IQR], 0.9-12.1 yr). The median time from randomization to inotropes was 16 minutes (IQR, 12-26 min) in the intervention group, and 49 minutes (IQR, 29-63 min) in the standard care group. The median amount of fluid delivered during the first 24 hours was 0 mL/kg (IQR, 0-10.0 mL/kg) in the intervention group, and 20.0 mL/kg (14.6-28.6 mL/kg) in the standard group (difference, -20.0; 95% CI, -28.0 to -12.0). The number of days alive and free of organ dysfunction did not differ between the intervention and standard care groups, with a median of 27 days (IQR, 26-27 d) versus 26 days (IQR, 25-27 d). There were no adverse events reported associated with the intervention. CONCLUSIONS: In children with septic shock, a protocol comparing early administration of adrenaline versus standard care achieved separation between the study arms in relation to inotrope and fluid bolus use.

Resuscitation With Vitamin C, Hydrocortisone, and Thiamin in Children With Septic Shock: A Multicenter Randomized Pilot Study.

OBJECTIVES: Adjunctive therapy with vitamin C, hydrocortisone, and thiamin has been evaluated in adults, but randomized controlled trial (RCT) data in children are lacking. We aimed to test the feasibility of vitamin C, hydrocortisone, and thiamin in PICU patients with septic shock; and to explore whether the intervention is associated with increased survival free of organ dysfunction. DESIGN: Open-label parallel, pilot RCT multicenter study. The primary endpoint was feasibility. Clinical endpoints included survival free of organ dysfunction censored at 28 days and nine secondary outcomes, shock reversal, and two proxy measures of intervention efficacy. SETTING: Six PICUs in Australia and New Zealand. PATIENTS: Children of age between 28 days and 18 years requiring vasoactive drugs for septic shock between August 2019 and March 2021. INTERVENTIONS: Patients were assigned 1:1 to receive 1 mg/kg hydrocortisone every 6 hours (q6h), 30 mg/kg ascorbic acid q6h, and 4 mg/kg thiamin every 12 hours (n = 27), or standard septic shock management (n = 33). MEASUREMENTS AND MAIN RESULTS: Sixty of 77 (78%) eligible patients consented with 91% of approached parents providing consent. The median time from randomization to intervention was 44 (interquartile range [IQR] 29-120) min. Seventy of seventy-seven (28%) patients had received IV steroids before randomization. Median survival alive and free of organ dysfunction was 20.0 (0.0-26.0) days in the intervention and 21.0 (0.0-25.0) days in the standard care group. Median PICU length of stay was 5.3 (2.5-11.3) days in the intervention group versus 6.9 (3.0-11.5) days in the control group. Shock reversal occurred at a median of 35.2 (14.6-101.2) hours in the intervention group versus 47.3 (22.4-106.8) hours in the standard care group (median difference -12 hr; 95% CI, -56.8 to 32.7 hr). CONCLUSIONS: In children requiring vasopressors for septic shock, a protocol comparing adjunctive treatment with high-dose vitamin C, hydrocortisone, and thiamin versus standard care was feasible. These findings assist in making modifications to the trial protocol to enable a better-designed larger RCT.

Nasal high flow therapy for bronchiolitis.

AIM: Uptake of nasal high-flow therapy in infants with bronchiolitis has grown in the last decade with some evidence suggesting a reduction in escalation of care. The effect of the implementation of recent available evidence on clinical practice remains unclear. METHODS: In a prospective observational study over 6 months in six metropolitan hospitals in Australia, we investigated the clinical practice of high-flow in infants admitted with bronchiolitis and an oxygen requirement. To assess the choice by clinicians of the initial oxygen therapy (standard oxygen or high-flow) the disease severity was measured by physiological parameters obtained prior to oxygen therapy commencement. Additional secondary outcomes were hospital length of stay and transfers to intensive care. RESULTS: Two hundred thirty-five infants with bronchiolitis were admitted for oxygen therapy over 6 months during the winter season. Infants who received high-flow on admission to hospital displayed significantly higher respiratory rates, higher heart rates and higher early warning tool scores with more severe work of breathing than those commenced on standard oxygen therapy as a first line of oxygen therapy. A significantly longer hospital length of stay of 0.6 days occurred in infants commenced on high-flow. A significantly greater proportion on high-flow (23.3%) were admitted to intensive care compared to infants commenced on SOT (10.4%) despite the severity of disease in both groups being similar. CONCLUSIONS: Infants with bronchiolitis presenting with greater disease severity are more likely to receive high-flow therapy. Escalation of care in an intensive care unit occurred more frequently on infants on high-flow. TRIAL REGISTRATION: This trial is registered in the Australian New Zealand Clinical Trial Registry ACTRN12618001206213.

Tracking the clonal dynamics of SARS-CoV-2-specific T cells in children and adults with mild/asymptomatic COVID-19.

Children infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) develop less severe coronavirus disease 2019 (COVID-19) than adults. The mechanisms for the age-specific differences and the implications for infection-induced immunity are beginning to be uncovered. We show by longitudinal multimodal analysis that SARS-CoV-2 leaves a small footprint in the circulating T cell compartment in children with mild/asymptomatic COVID-19 compared to adult household contacts with the same disease severity who had more evidence of systemic T cell interferon activation, cytotoxicity and exhaustion. Children harbored diverse polyclonal SARS-CoV-2-specific naïve T cells whereas adults harbored clonally expanded SARS-CoV-2-specific memory T cells. A novel population of naïve interferon-activated T cells is expanded in acute COVID-19 and is recruited into the memory compartment during convalescence in adults but not children. This was associated with the development of robust CD4+ memory T cell responses in adults but not children. These data suggest that rapid clearance of SARS-CoV-2 in children may compromise their cellular immunity and ability to resist reinfection.

The characteristics of SARS-CoV-2-positive children in Australian hospitals: a PREDICT network study.

OBJECTIVES: To examine the clinical characteristics and short term outcomes for children with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections who presented to Australian hospitals during 2020 and 2021. DESIGN, SETTING: Retrospective case review study in nineteen hospitals of the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network from all Australian states and territories, including seven major paediatric tertiary centres and eight Victorian hospitals. PARTICIPANTS: SARS-CoV-2-positive people under 18 years of age who attended emergency departments or were admitted to hospital during 1 February 2020 - 31 December 2021. MAIN OUTCOME MEASURES: Epidemiological and clinical characteristics, by hospital care type (emergency department [ED] or inpatient care). RESULTS: A total of 1193 SARS-CoV-2-positive children and adolescents (527 girls, 44%) attended the participating hospitals (107 in 2020, 1086 in 2021). Their median age was 3.8 years (interquartile range [IQR], 0.8-11.4 years); 63 were Aboriginal or Torres Strait Islander people (5%). Other medical conditions were recorded for 293 children (25%), including asthma (86, 7%) and premature birth (68, 6%). Medical interventions were not required during 795 of 1181 ED presentations (67%); children were discharged directly home in 764 cases (65%) and admitted to hospital in 282 (24%; sixteen to intensive care units). The 384 admissions to hospital (including 102 direct admissions) of 341 children (25 infants under one month of age) included 23 to intensive care (6%); the median length of stay was three days (IQR, 1-9 days). Medical interventions were not required during 261 admissions (68%); 44 children received respiratory support (11%) and 21 COVID-19-specific treatments, including antiviral and biologic agents (5%). Being under three months of age (v one year to less than six years: odds ratio [OR], 2.6; 95% confidence interval [CI], 1.7-4.0) and pre-existing medical conditions (OR, 2.5; 95% CI, 1.9-3.2) were the major predictors of hospital admission. Two children died, including one without a known pre-existing medical condition. CONCLUSION: During 2020 and 2021, most SARS-CoV-2-positive children and adolescents who presented to participating hospitals could be managed as outpatients. Outcomes were generally good, including for those admitted to hospital.

Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure: The PARIS-2 Randomized Clinical Trial.

Importance: Nasal high-flow oxygen therapy in infants with bronchiolitis and hypoxia has been shown to reduce the requirement to escalate care. The efficacy of high-flow oxygen therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure without bronchiolitis is unknown. Objective: To determine the effect of early high-flow oxygen therapy vs standard oxygen therapy in children with acute hypoxemic respiratory failure. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted at 14 metropolitan and tertiary hospitals in Australia and New Zealand, including 1567 children aged 1 to 4 years (randomized between December 18, 2017, and March 18, 2020) requiring hospital admission for acute hypoxemic respiratory failure. The last participant follow-up was completed on March 22, 2020. Interventions: Enrolled children were randomly allocated 1:1 to high-flow oxygen therapy (n = 753) or standard oxygen therapy (n = 764). The type of oxygen therapy could not be masked, but the investigators remained blinded until the outcome data were locked. Main Outcomes and Measures: The primary outcome was length of hospital stay with the hypothesis that high-flow oxygen therapy reduces length of stay. There were 9 secondary outcomes, including length of oxygen therapy and admission to the intensive care unit. Children were analyzed according to their randomization group. Results: Of the 1567 children who were randomized, 1517 (97%) were included in the primary analysis (median age, 1.9 years [IQR, 1.4-3.0 years]; 732 [46.7%] were female) and all children completed the trial. The length of hospital stay was significantly longer in the high-flow oxygen group with a median of 1.77 days (IQR, 1.03-2.80 days) vs 1.50 days (IQR, 0.85-2.44 days) in the standard oxygen group (adjusted hazard ratio, 0.83 [95% CI, 0.75-0.92]; P < .001). Of the 9 prespecified secondary outcomes, 4 showed no significant difference. The median length of oxygen therapy was 1.07 days (IQR, 0.50-2.06 days) in the high-flow oxygen group vs 0.75 days (IQR, 0.35-1.61 days) in the standard oxygen therapy group (adjusted hazard ratio, 0.78 [95% CI, 0.70-0.86]). In the high-flow oxygen group, there were 94 admissions (12.5%) to the intensive care unit compared with 53 admissions (6.9%) in the standard oxygen group (adjusted odds ratio, 1.93 [95% CI, 1.35-2.75]). There was only 1 death and it occurred in the high-flow oxygen group. Conclusions and Relevance: Nasal high-flow oxygen used as the initial primary therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure did not significantly reduce the length of hospital stay compared with standard oxygen therapy. Trial Registration: anzctr.org.au Identifier: ACTRN12618000210279.

Research monitoring practices in critical care research: a survey of current state and attitudes.

BACKGROUND/AIMS: In 2016, international standards governing clinical research recommended that the approach to monitoring a research project should be undertaken based on risk, however it is unknown whether this approach has been adopted in Australia and New Zealand (ANZ) throughout critical care research. The aims of the project were to: 1) Gain an understanding of current research monitoring practices in academic-led clinical trials in the field of critical care research, 2) Describe the perceived barriers and enablers to undertaking research monitoring. METHODS: Electronic survey distributed to investigators, research co-ordinators and other research staff currently undertaking and supporting academic-led clinical trials in the field of critical care in ANZ. RESULTS: Of the 118 respondents, 70 were involved in the co-ordination of academic trials; the remaining results pertain to this sub-sample. Fifty-eight (83%) were working in research units associated with hospitals, 29 (41%) were experienced Research Coordinators and 19 (27%) Principal Investigators; 31 (44%) were primarily associated with paediatric research. Fifty-six (80%) develop monitoring plans with 33 (59%) of these undertaking a risk assessment; the most common barrier reported was lack of expertise. Nineteen (27%) indicated that centralised monitoring was used, noting that technology to support centralised monitoring (45/51; 88%) along with support from data managers and statisticians (45/52; 87%) were key enablers. Coronavirus disease-19 (COVID-19) impacted monitoring for 82% (45/55) by increasing remote (25/45; 56%) and reducing onsite (29/45; 64%) monitoring. CONCLUSIONS: Contrary to Good Clinical Practice guidance, risk assessments to inform monitoring plans are not being consistently performed due to lack of experience and guidance. There is an urgent need to enhance risk assessment methodologies and develop technological solutions for centralised statistical monitoring.

The characteristics of SARS-CoV-2-positive children who presented to Australian hospitals during 2020: a PREDICT network study.

OBJECTIVES: To examine the epidemiological and clinical characteristics of SARS-CoV-2-positive children in Australia during 2020. DESIGN, SETTING: Multicentre retrospective study in 16 hospitals of the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network; eleven in Victoria, five in four other Australian states. PARTICIPANTS: Children aged 0-17 years who presented to hospital-based COVID-19 testing clinics, hospital wards, or emergency departments during 1 February - 30 September 2020 and who were positive for SARS-CoV-2. MAIN OUTCOME MEASURES: Epidemiological and clinical characteristics of children positive for SARS-CoV-2. RESULTS: A total of 393 SARS-CoV-2-positive children (181 girls, 46%) presented to the participating hospitals (426 presentations, including 131 to emergency departments [31%]), the first on 3 February 2020. Thirty-three children presented more than once (8%), including two who were transferred to participating tertiary centres (0.5%). The median age of the children was 5.3 years (IQR, 1.9-12.0 years; range, 10 days to 17.9 years). Hospital admissions followed 51 of 426 presentations (12%; 44 children), including 17 patients who were managed remotely by hospital in the home. Only 16 of the 426 presentations led to hospital medical interventions (4%). Two children (0.5%) were diagnosed with the paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS). CONCLUSION: The clinical course for most SARS-CoV-2-positive children who presented to Australian hospitals was mild, and did not require medical intervention.

Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial.

BACKGROUND: Phenytoin is the current standard of care for second-line treatment of paediatric convulsive status epilepticus after failure of first-line benzodiazepines, but is only effective in 60% of cases and is associated with considerable adverse effects. A newer anticonvulsant, levetiracetam, can be given more quickly, is potentially more efficacious, and has a more tolerable adverse effect profile. We aimed to determine whether phenytoin or levetiracetam is the superior second-line treatment for paediatric convulsive status epilepticus. METHODS: ConSEPT was an open-label, multicentre, randomised controlled trial conducted in 13 emergency departments in Australia and New Zealand. Children aged between 3 months and 16 years, with convulsive status epilepticus that failed first-line benzodiazepine treatment, were randomly assigned (1:1) using a computer-generated permuted block (block sizes 2 and 4) randomisation sequence, stratified by site and age (≤5 years, >5 years), to receive 20 mg/kg phenytoin (intravenous or intraosseous infusion over 20 min) or 40 mg/kg levetiracetam (intravenous or intraosseous infusion over 5 min). The primary outcome was clinical cessation of seizure activity 5 min after the completion of infusion of the study drug. Analysis was by intention to treat. This trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12615000129583. FINDINGS: Between March 19, 2015, and Nov 29, 2017, 639 children presented to participating emergency departments with convulsive status epilepticus; 127 were missed, and 278 did not meet eligibility criteria. The parents of one child declined to give consent, leaving 233 children (114 assigned to phenytoin and 119 assigned to levetiracetam) in the intention-to-treat population. Clinical cessation of seizure activity 5 min after completion of infusion of study drug occurred in 68 (60%) patients in the phenytoin group and 60 (50%) patients in the levetiracetam group (risk difference -9·2% [95% CI -21·9 to 3·5]; p=0·16). One participant in the phenytoin group died at 27 days because of haemorrhagic encephalitis; this death was not thought to be due to the study drug. There were no other serious adverse events. INTERPRETATION: Levetiracetam is not superior to phenytoin for second-line management of paediatric convulsive status epilepticus. FUNDING: Health Research Council of New Zealand, A+ Trust, Emergency Medicine Foundation, Townsville Hospital Private Practice Fund, Eric Ormond Baker Charitable Fund, and Princess Margaret Hospital Foundation.

The Effects of On-Pump and Off-Pump Coronary Artery Bypass Surgery on Respiratory Function in the Early Postoperative Period.

BACKGROUND:: Respiratory complications are common after cardiac surgery and the use of extracorporeal circulation is one of the main causes of lung injury. We hypothesized a better postoperative respiratory function in off-pump coronary artery bypass grafting (OPCABG) as compared with "on-pump coronary artery bypass grafting" (ONCABG). METHODS:: This is a retrospective, single-center study at a cardiothoracic intensive care unit (ICU) in a tertiary university hospital. Consecutive data on 339 patients undergoing elective CABG (n = 215 ONCABG, n = 124 OPCABG) were collected for 1 year from the ICU electronic medical records. We compared respiratory variables (Pao2, Pao2/Fio2 ratio, Sao2, and Paco2) at 7 predefined time points (ICU admission, postoperative hours 1, 3, 6, 12, 18, and 24). We also evaluated time to extubation, rates of reintubation, and use of noninvasive ventilation (NIV). We used mixed-effects linear regression models (with time as random effect for clustering of repeated measures) adjusted for a predetermined set of covariates. RESULTS:: The values of Pao2 and Pao2/Fio2 were significantly higher in the OPCABG group only at ICU admission (mean differences: 9.7 mm Hg, 95% confidence interval [CI] 3.1-16.2; and 27, 95% CI 6.1-47.7, respectively). The OPCABG group showed higher Paco2, overall ( P = .02) and at ICU admission (mean difference 1.8 mm Hg, 95% CI: 0.6-3), although mean values were always within normal range in both groups. No differences were seen in Sao2 values, time to extubation, rate of reintubation rate, and use of postoperative NIV. Extubation rate was higher in OPCABG only at postoperative hour 12 (92% vs ONCABG 82%, P = .02). CONCLUSION:: The OPCABG showed only marginal improvements of unlikely clinical meaning in oxygenation as compared to ONCABG in elective low-risk patients.

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.

BACKGROUND: Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. METHODS/DESIGN: 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. DISCUSSION: This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. TRIAL REGISTRATION: Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).

Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.

BACKGROUND: Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell's palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell's palsy in children in a randomised placebo-controlled trial. METHODS/DESIGN: We are conducting a randomised, triple-blinded, placebo controlled trial of the use of prednisolone to improve recovery from Bell's palsy at 1 month. Study sites are 10 hospitals within the Australian and New Zealand PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. 540 participants will be enrolled. To be eligible patients need to be aged 6 months to < 18 years and present within 72 hours of onset of clinician diagnosed Bell's palsy to one of the participating hospital emergency departments. Patients will be excluded in case of current use of or contraindications to steroids or if there is an alternative diagnosis. Participants will receive either prednisolone 1 mg/kg/day to a maximum of 50 mg/day or taste matched placebo for 10 days. The primary outcome is complete recovery by House-Brackmann scale at 1 month. Secondary outcomes include assessment of recovery using the Sunnybrook scale, the emotional and functional wellbeing of the participants using the Pediatric Quality of Life Inventory and Child Health Utility 9D Scale, pain using Faces Pain Scale Revised or visual analogue scales, synkinesis using a synkinesis assessment questionnaire and health utilisation costs at 1, 3 and 6 months. Participants will be tracked to 12 months if not recovered earlier. Data analysis will be by intention to treat with primary outcome presented as differences in proportions and an odds ratio adjusted for site and age. DISCUSSION: This large multicenter randomised trial will allow the definitive assessment of the efficacy of prednisolone compared with placebo in the treatment of Bell's palsy in children. TRIAL REGISTRATION: The study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015).

Bell's palsy in children: Current treatment patterns in Australia and New Zealand. A PREDICT study.

AIM: The aetiology and clinical course of Bell's palsy may be different in paediatric and adult patients. There is no randomised placebo controlled trial (RCT) to show effectiveness of prednisolone for Bell's palsy in children. The aim of the study was to assess current practice in paediatric Bell's palsy in Australia and New Zealand Emergency Departments (ED) and determine the feasibility of conducting a multicentre RCT within the Paediatric Research in Emergency Departments International Collaborative (PREDICT). METHODS: A retrospective analysis of ED medical records of children less than 18 years diagnosed with Bell's palsy between 1 January, 2012 and 31 December, 2013 was performed. Potential participants were identified from ED information systems using Bell's palsy related search terms. Repeat presentations during the same illness were excluded but relapses were not. Data on presentation, diagnosis and management were entered into an online data base (REDCap). RESULTS: Three hundred and twenty-three presentations were included from 14 PREDICT sites. Mean age at presentation was 9.0 (SD 5.0) years with 184 (57.0%) females. Most (238, 73.7%) presented to ED within 72 h of symptoms, 168 (52.0%) had seen a doctor prior. In ED, 218 (67.5%) were treated with steroids. Prednisolone was usually prescribed for 9 days at around 1 mg/kg/day, with tapering in 35.7%. CONCLUSION: Treatment of Bell's palsy in children presenting to Australasian EDs is varied. Prednisolone is commonly used in Australasian EDs, despite lack of high-level paediatric evidence. The study findings confirm the feasibility of an RCT of prednisolone for Bell's palsy in children.

The Effects of On-Pump and Off-Pump Coronary Artery Bypass Surgery on Metabolic Profiles in the Early Postoperative Period.

OBJECTIVE: Hyperlactatemia and base deficit (BD) are markers of adverse outcome after cardiac surgery, and their derangement can be influenced by the use of extracorporeal circulation. The authors hypothesized a better postoperative metabolic profile in off-pump coronary artery bypass grafting (OPCABG) compared with "on-pump" coronary artery bypass grafting (ONCABG). DESIGN: This was a retrospective study, with consecutive data collected for 1 year from electronic medical records. SETTING: Cardiothoracic intensive care unit at a tertiary university hospital. PARTICIPANTS: The study comprised 339 patients who underwent elective coronary artery bypass grafting (ONCABG [n = 215], OPCABG [n = 124]). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The metabolic (arterial lactatemia, pH, and BD) and hemodynamic (inotropic/vasopressor support) parameters of OPCABG and ONCABG patients were compared at 7 predefined time points (intensive care admission and the 1st, 3rd, 6th, 12th, 18th, and 24th postoperative hours). For each output of interest, mixed-effects linear regression models were used (with time as random-effect to allow for clustering of repeated measures) and adjusted for a predetermined set of covariates. Arterial lactatemia and pH were comparable at all time points; BD was worse in the ONCABG group overall (p = 0.01) and at most time points (except at the 1st and 24th postoperative hours). For the whole period, inotropic support was more common in ONCABG patients (p<0.05), whereas vasopressor use was more frequent in the OPCABG group (p< 0.05). CONCLUSIONS: Improved postoperative BD values were demonstrated in the OPCABG group, although pH and lactatemia were similar between groups. Inotropic support was less common in the OPCABG group at the expense of more frequent vasopressor support.

Adaptive platform trials rather than randomised controlled trials for paediatric sepsis.

Adaptive platform trials (APTs) offer a promising alternative to traditional randomised controlled trials for evaluating treatments for paediatric sepsis. Randomised controlled trials, despite being the gold standard for establishing causality between interventions and outcomes, make many assumptions about disease prevalence, severity and intervention effects, which are often incorrect. As a result, the evidence for most treatments for paediatric sepsis are based on low-quality evidence. APTs use accrued data rather than assumptions to power trial adaptations. They can assess multiple treatments simultaneously with shared research infrastructure. As such, APTs offer a more efficient, flexible and more effective way to identify optimal treatments. The proposed Paediatric Adaptive Sepsis Platform Trial, leveraging the Paediatric Research in Emergency Departments International Collaborative network's infrastructure, will evaluate resuscitation fluids, vasoactive medications, corticosteroids and antimicrobials. This trial has the potential to substantially impact clinical practice and reduce global sepsis mortality in children.

Factors associated with difficult intravenous access in the paediatric emergency department: A prospective cohort study.

OBJECTIVES: Although it is the most performed invasive procedure, peripheral intravenous catheter (PIVC) insertion in children can be difficult. The primary objective of the study was to identify the factors associated with difficult intravenous access (DIVA) in the paediatric ED, including patient, proceduralist and situational factors. METHODS: This was a single-centre prospective observational cohort study conducted over 28 consecutive days. Research assistants observed PIVC insertion attempts for children under 16 years of age and recorded data for variables relating to the patient, proceduralist and event. Univariate logistic regression modelling was performed to identify factors associated with DIVA, defined as unsuccessful PIVC insertion on the first attempt. RESULTS: A total of 134 participants were recruited; 66 were male (49%) with a median age of 5.7 years. Fifty-two (39%) were classified as having DIVA. There was a total of 207 PIVC insertion attempts with two or more attempts needed for 48 children (36%). Patient factors associated with DIVA included age of 3 years or less and limited vein options. Proceduralist factors included gestalt of 50% or less chance of success, use of a larger gauge (smaller bore) PIVC and less PIVC insertion experience. Situational factors included a combative child, higher pain score and loud ambient noise. CONCLUSIONS: The present study identified multiple patient, proceduralist and situational factors that were associated with DIVA in the paediatric ED. Future studies should explore the development and implementation of a package to address DIVA in children, with the patient-centred goals of reducing pain and improving success.

Morning or Afternoon Scheduling for Elective Coronary Artery Bypass Surgery: Influence of Longer Fasting Periods from Metabolic and Hemodynamic Perspectives.

BACKGROUND: Prolonged preoperative fasting may worsen postoperative outcomes. Cardiac surgery has higher perioperative risk, and longer fasting periods may be not well-tolerated. We analysed the postoperative metabolic and hemodynamic variables in patients undergoing elective coronary artery bypass grafting (CABG) according to their morning or afternoon schedule. METHODS: Single-centre retrospective study at University teaching hospital (1-year data collection from electronic medical records). Using a mixed-effects linear regression model adjusted for several covariates, we compared metabolic (lactatemia, pH, and base deficit [BD]) and haemodynamic values (patients on vasoactive support, and vasoactive inotropic score [VIS]) at 7 prespecified time-points (admission to intensive care, and 1st, 3rd, 6th, 12th, 18th, and 24th postoperative hours). RESULTS: 339 patients (n = 176 morning, n = 163 afternoon) were included. Arterial lactatemia and BD were similar (overall P = 0.11 and P = 0.84, respectively), while pH was significantly lower in the morning group (overall P < 0.05; mean difference -0.01). Postoperative urine output, fluid balance, mean arterial pressure, and central venous pressure were similar (P = 0.59, P = 0.96, P = 0.58 and P = 0.53, respectively). A subgroup analysis of patients with diabetes (n = 54 morning, n = 45 afternoon) confirmed the same findings. The VIS values and the proportion of patients on vasoactive support was higher in the morning cases at the 18th (P = 0.002 and p=0.04, respectively) and 24th postoperative hours (P = 0.003 and P = 0.04, respectively). Mean intensive care length of stay was 1.94 ± 1.36 days versus 2.48 ± 2.72 days for the afternoon and morning cases, respectively (P = 0.02). CONCLUSIONS: Patients undergoing elective CABG showed similar or better metabolic and hemodynamic profiles when scheduled for afternoon surgery.

Appraisal of Australian and New Zealand paediatric sepsis guidelines.

OBJECTIVE: Clinical practice guidelines (CPGs) are an important tool for the management of children with sepsis. The quality, consistency and concordance of Australian and New Zealand (ANZ) childhood sepsis CPGs with the Australian Commission on Safety and Quality in Healthcare (ACSQHC) sepsis clinical care standards and international sepsis guidelines is unclear. METHODS: We accessed childhood sepsis CPGs for all ANZ states and territories through Paediatric Research in Emergency Departments International Collaborative members. The guidelines were assessed for quality using the AGREE-II instrument. Consistency between CPG treatment recommendations was assessed, as was concordance with the ACSQHC sepsis clinical care standards and international sepsis guidelines. RESULTS: Overall, eight CPGs were identified and assessed. CPGs used a narrative and pathway format, with those using both having the highest quality overall. CPG quality was highest for description of scope and clarity of presentation, and lowest for editorial independence. Consistency between guidelines for initial treatment recommendations was poor, with substantial variation in the choice and urgency of empiric antimicrobial administration; the choice, volume and urgency of fluid resuscitation; and the choice of first-line vasoactive agent. Most CPGs were concordant with time-critical components of the ACSQHC sepsis clinical care standard, although few addressed post-acute care. Concordance with international sepsis guidelines was poor. CONCLUSION: Childhood sepsis CPGs in current use in ANZ are of variable quality and lack consistency with key treatment recommendations. CPGs are concordant with the ACSQHC care standard, but not with international sepsis guidelines. A bi-national sepsis CPG may reduce unnecessary variation in care.