Facial Function in Bell Palsy in a Cohort of Children Randomized to Prednisolone or Placebo 12 Months After Diagnosis.

BACKGROUND: Information on the medium-term recovery of children with Bell palsy or acute idiopathic lower motor neuron facial paralysis is limited. METHODS: We followed up children aged 6 months to <18 years with Bell palsy for 12 months after completion of a randomized trial on the use of prednisolone. We assessed facial function using the clinician-administered House-Brackmann scale and the modified parent-administered House-Brackmann scale. RESULTS: One hundred eighty-seven children were randomized to prednisolone (n = 93) or placebo (n = 94). At six months, the proportion of patients who had recovered facial function based on the clinician-administered House-Brackmann scale was 98% (n = 78 of 80) in the prednisolone group and 93% (n = 76 of 82) in the placebo group. The proportion of patients who had recovered facial function based on the modified parent-administered House-Brackmann scale was 94% (n = 75 of 80) vs 89% (n = 72 of 81) at six months (OR 1.88; 95% CI 0.60, 5.86) and 96% (n = 75 of 78) vs 92% (n = 73 of 79) at 12 months (OR 3.12; 95% CI 0.61, 15.98). CONCLUSIONS: Although the vast majority had complete recovery of facial function at six months, there were some children without full recovery of facial function at 12 months, regardless of prednisolone use.

Pain in children with Bell's palsy: secondary analysis of a randomised controlled trial.

OBJECTIVE: To describe the prevalence and severity of pain experienced by children with Bell's palsy over the first 6 months of illness and its association with the severity of facial paralysis. METHODS: This was a secondary analysis of data obtained in a phase III, triple-blinded, randomised, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children aged 6 months to <18 years conducted between 13 October 2015 and 23 August 2020 in Australia and New Zealand. Children were recruited within 72 hours of symptom onset and pain was assessed using a child-rated visual analogue scale (VAS), a child-rated Faces Pain Score-Revised (FPS-R) and/or a parent-rated VAS at baseline, and at 1, 3 and 6 months until recovered, and are reported combined across treatment groups. RESULTS: Data were available for 169 of the 187 children randomised from at least one study time point. Overall, 37% (62/169) of children reported any pain at least at one time point. The frequency of any pain reported using the child-rated VAS, child-rated FPS-R and parent-rated VAS was higher at the baseline assessment (30%, 23% and 27%, respectively) compared with 1-month (4%, 0% and 4%, respectively) and subsequent follow-up assessments. At all time points, the median pain score on all three scales was 0 (no pain). CONCLUSIONS: Pain in children with Bell's palsy was infrequent and primarily occurred early in the disease course and in more severe disease. The intensity of pain, if it occurs, is very low throughout the clinical course of disease. TRIAL REGISTRATION NUMBER: ACTRN12615000563561.

Cost-effectiveness of Prednisolone to Treat Bell Palsy in Children: An Economic Evaluation Alongside a Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Bell palsy is the third most frequent diagnosis in children with sudden-onset neurologic dysfunction. The cost-effectiveness of treating Bell palsy with prednisolone in children is unknown. We aimed to assess the cost-effectiveness of prednisolone in treating Bell palsy in children compared with placebo. METHODS: This economic evaluation was a prospectively planned secondary analysis of a double-blinded, randomized, placebo-controlled superiority trial (Bell Palsy in Children [BellPIC]) conducted from 2015 to 2020. The time horizon was 6 months since randomization. Children aged 6 months to <18 years who presented within 72 hours of onset of clinician-diagnosed Bell palsy and who completed the trial were included (N = 180). Interventions were oral prednisolone or taste-matched placebo administered for 10 days. Incremental cost-effectiveness ratio comparing prednisolone with placebo was estimated. Costs were considered from a health care sector perspective and included Bell palsy-related medication cost, doctor visits, and medical tests. Effectiveness was measured using quality-adjusted life-years (QALYs) based on Child Health Utility 9D. Nonparametric bootstrapping was performed to capture uncertainties. Prespecified subgroup analysis by age 12 to <18 years vs <12 years was conducted. RESULTS: The mean cost per patient was A$760 in the prednisolone group and A$693 in the placebo group over the 6-month period (difference A$66, 95% CI -A$47 to A$179). QALYs over 6 months were 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95% CI -0.01 to 0.03). The incremental cost to achieve 1 additional recovery was estimated to be A$1,577 using prednisolone compared with placebo, and cost per additional QALY gained was A$6,625 using prednisolone compared with placebo. Given a conventional willingness-to-pay threshold of A$50,000 per QALY gained (equivalent to US$35,000 or £28,000), prednisolone is very likely cost-effective (probability is 83%). Subgroup analysis suggests that this was primarily driven by the high probability of prednisolone being cost-effective in children aged 12 to <18 years (probability is 98%) and much less so for those <12 years (probability is 51%). DISCUSSION: This provides new evidence to stakeholders and policymakers when considering whether to make prednisolone available in treating Bell palsy in children aged 12 to <18 years. TRIAL REGISTRATION INFORMATION: Australian New Zealand Clinical Trials Registry ACTRN12615000563561.

Agreement of Clinician-Administered and Modified Parent-Administered House-Brackmann Scales in Children with Bell's Palsy.

Objective: Currently there is no parent administered scale for facial nerve function in children. We set out to assess the agreement between a newly developed parent-administered modified version of the House-Brackmann (HB) scale and the standard clinician-administered HB scale in children with Bell's palsy. Study Design: Secondary analysis of a triple-blind, randomized, placebo-controlled trial of corticosteroids to treat idiopathic facial paralysis (Bell's palsy) in children (6 months to <18 years). Setting: Multicenter study at pediatric hospitals with recruitment in emergency departments. Methods: Children were recruited within 72 hours of symptom onset and assessed using the clinician-administered and the parent-administered modified HB scales at baseline, and at 1, 3, and 6 months until recovered. Agreement between the 2 scales was assessed using intraclass coefficient (ICC) and a Bland-Altman plot. Results: Data were available for 174 of the 187 children randomized from at least 1 study time point. The mean ICC between clinician and parent HB scores across all time points was 0.88 (95% confidence interval, CI: 0.86, 0.90). The ICC for the data collected at baseline was 0.53 (95% CI: 0.43, 0.64), at 1 month was 0.88 (95% CI: 0.84, 0.91), at 3 months was 0.80 (95% CI: 0.71, 0.87) and at 6 months was 0.73 (95% CI: 0.47, 0.89). A Bland-Altman plot indicated a mean difference between the 2 scores (clinician-reported minus parent-reported) of only -0.07 (95% limits of agreement -1.37 to 1.23). Conclusion: There was good agreement between the modified parent-administered and the clinician-administered HB scales.

Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND AND OBJECTIVE: Corticosteroids are used to treat the early stages of idiopathic facial paralysis (Bell's palsy) in children, but their effectiveness is uncertain. We set out to determine if prednisolone improves the proportion of children with Bell's palsy with complete recovery at one month. METHODS: We conducted a double-blind, placebo-controlled, randomised trial of prednisolone in children presenting to emergency departments with Bell's palsy. Patients aged 6 months to less than 18 years, recruited within 72 hours after symptom onset, were randomly assigned to receive 10 days of treatment with oral prednisolone (approximately 1 mg/kg) or placebo. The primary outcome was complete recovery of facial function at 1 month rated on the House-Brackmann scale. Secondary outcomes included facial function, adverse events and pain up to 6 months. Target recruitment was n=540 (270 per group). RESULTS: Between 13 October 2015 to 23 August 2020, 187 children were randomised (94 to prednisolone and 93 to placebo) and included in the intention-to-treat analysis. At 1 month, the proportions of patients who had recovered facial function were 49% (n=43/87) in the prednisolone group compared with 57% (n=50/87) in the placebo group (risk difference -8.1%, 95% CI -22.8 to 6.7; adjusted odds ratio [aOR] 0.7, 95% CI 0.4 to 1.3). At 3 months these proportion were 90% (n=71/79) for the prednisolone group versus 85% (n=72/85) for the placebo group (risk difference 5.2%, 95%, CI -5.0 to 15.3; aOR 1.2, 95% CI 0.4 to 3.0) and at 6 months 99% (n=77/78) and 93% (n=76/82) respectively (risk difference 6.0%, 95% CI -0.1 to 12.2; aOR 3.0 95% CI 0.5 to 17.7) There were no serious adverse events and little evidence for group differences in secondary outcomes. DISCUSSION: In children with Bell's palsy the vast majority recover without treatment. The study, although underpowered, does not provide evidence that early treatment with prednisolone improves complete recovery. REGISTRATION: Registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561, registered 1 June 2015, ://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368505&isReview=true CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for children with Bell's palsy, prednisolone does not significantly change recovery of complete facial function at one month. However, the study lacked the precision to exclude an important harm or benefit from prednisolone.

Building effective engagement for implementation with i-PARIHS: a collaborative enquiry into paediatric pain care in the emergency department.

BACKGROUND: Pain is a central and distressing experience for children in the emergency department (ED). Despite the harmful effects of pain, ED care often falls short of providing timely and effective pain relief. Knowledge translation research targeting systems of care holds potential to transform paediatric pain care. This article reports on the first stages of an implementation project aimed at embedding effective and sustainable practice change in an Australian children's hospital ED. METHODS: The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework underpinned a cooperative process of engagement to establish a practitioner-led, interprofessional research collaborative. The Kids Pain Collaborative (KPC) aimed to co-design innovation in paediatric ED pain care, facilitating an extensive reconnaissance of research evidence, clinician and family experiences, and local evaluation data. This critical appraisal of the context and culture of pain management generated foci for innovation and facilitation of implementation action cycles. RESULTS: Engaging in a complex process of facilitated critical reflection, the KPC unpacked deeply embedded assumptions and organisational practices for pain care that worked against what they wanted to achieve as a team. A culture of rules-based pain management and command and control leadership produced self-defeating practices and ultimately breakdowns in pain care. By raising a critical awareness of context, and building consensus on the evidence for change, the KPC has established a whole of ED shared vision for prioritising pain care. CONCLUSIONS: In-depth key stakeholder collaboration and appraisal of context is the first step in innovation of practice change. The KPC provided a space for collaborative enquiry where ED clinicians and researchers could develop context-specific innovation and implementation strategy. We provide an example of the prospective application of i-PARIHS in transforming ED pain care, using a collaborative and participatory approach that has successfully enabled high levels of departmental engagement, motivation and ownership of KPC implementation as the facilitation journey unfolds.

Nurse practitioner administered point-of-care ultrasound compared with X-ray for children with clinically non-angulated distal forearm fractures in the ED: a diagnostic study.

BACKGROUND: Paediatric distal forearm fractures are a common ED presentation. They can be diagnosed with point-of-care ultrasound (POCUS) as an alternative to X-rays. Given that ED nurse practitioners (NPs) are relied on for the diagnosis of paediatric fractures, it is important to describe the diagnostic accuracy of NP-conducted POCUS versus X-ray. METHODS: This prospective diagnostic study was conducted in a tertiary paediatric hospital in Queensland, Australia, between February 2018 and April 2019. Participants were children aged 4-16 years with a clinically non-angulated, suspected distal forearm fracture. Diagnosis from 6-view NP-administered POCUS of the distal radius and ulna was compared against the reference standard of 2-view X-ray. Each patient received both imaging modalities. Overall forearm diagnosis was classified as 'no', 'buckle' or 'other' fracture for both modalities. The primary outcome was diagnostic accuracy for 'any' fracture ('buckle' and 'other' fractures combined). Secondary outcomes included diagnostic accuracy for 'other' fractures versus 'buckle' and 'no' fractures combined, and pain, imaging duration and preference for modality. RESULTS: Of 204 recruited patients, 129 had X-ray-diagnosed forearm fractures. The sensitivity and specificity for NP-administered POCUS were 94.6% (95% CI 89.2% to 97.3%) and 85.3% (95% CI 75.6% to 91.6%), respectively. 'Other' fractures (mostly cortical breach fractures), when compared with 'buckle'/ 'no' fractures, had sensitivity 81.0% (95% CI 69.1% to 89.1%) and specificity 95.9% (95% CI 91.3% to 98.1%). Pain and imaging duration were clinically similar between modalities. There was a preference for POCUS by patients, parents and NPs. CONCLUSIONS: NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries. This included good sensitivity for diagnosis of 'any' fracture and good specificity for diagnosis of cortical breach fractures alone. Given the preference for POCUS, and the lack of difference in pain and duration between modalities, future research should consider functional outcomes comparing POCUS with X-ray in this population in a randomised controlled trial.

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).

Vapocoolants (cold spray) for pain treatment during intravenous cannulation.

BACKGROUND: Intravenous cannulation is a painful procedure that can provoke anxiety and stress. Injecting local anaesthetic can provide analgesia at the time of cannulation, but it is a painful procedure. Topical anaesthetic creams take between 30 and 90 minutes to produce an effect. A quicker acting analgesic allows more timely investigation and treatment. Vapocoolants have been used in this setting, but studies have reported mixed results. OBJECTIVES: To determine effects of vapocoolants on pain associated with intravenous cannulation in adults and children. To explore variables that might affect the performance of vapocoolants, including time required for application, distance from the skin when applied and time to cannulation. To look at adverse effects associated with the use of vapocoolants. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Latin American Caribbean Health Sciences Literature (LILACS), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Institute for Scientific Information (ISI) Web of Science and the http://clinicaltrials.gov/, http://www.controlled-trials.com/ and http://www.trialscentral.org/ databases to 1 May 2015. We applied no language restrictions. We also scanned the reference lists of included papers. SELECTION CRITERIA: We included all blinded and unblinded randomized controlled trials (RTCs) comparing any vapocoolant with placebo or control to reduce pain during intravenous cannulation in adults and children. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trial quality and extracted data, contacted study authors for additional information and assessed included studies for risk of bias. We collected and analysed data for the primary outcome of pain during cannulation, and for the secondary outcomes of pain associated with application of the vapocoolant, first attempt success rate of intravenous cannulation, adverse events and participant satisfaction. We performed subgroup analyses for the primary outcome to examine differences based on age of participant, type of vapocoolant used, application time of vapocoolant and clinical situation (emergency vs elective). We used random-effects model meta-analysis in RevMan 5.3 and assessed heterogeneity between trial results by examining forest plots and calculating the I(2) statistic. MAIN RESULTS: We found nine suitable studies of 1070 participants and included them in the qualitative analyses. We included eight studies of 848 participants in the meta-analysis for the primary outcome (pain during intravenous cannulation). Use of vapocoolants resulted in a reduction in pain scores as measured by a linear 100 mm visual analogue scale (VAS 100) compared with controls (difference between means -12.5 mm, 95% confidence interval (CI) -18.7 to -6.4 mm; moderate-quality evidence). We could not include in the meta-analysis one study, which showed no effects of the intervention.Use of vapocoolants resulted in increased pain scores at the time of application as measured by a VAS 100 compared with controls (difference between means 6.3 mm, 95% CI 2.2 to 10.3 mm; four studies, 461 participants; high-quality evidence) and led to no difference in first attempt success compared with controls (risk ratio (RR) 1.00, 95% CI 0.94 to 1.06; six studies, 812 participants; moderate-quality evidence). We documented eight minor adverse events reported in 279 vapocoolant participants (risk difference (RD) 0.03, 95% CI 0 to 0.05; five studies, 551 participants; low quality-evidence).The overall risk of bias of individual studies ranged from low to high, with high risk of bias for performance and detection bias in four studies. Sensitivity analysis showed that exclusion of studies at high or unclear risk of bias did not materially alter the results of this review. AUTHORS' CONCLUSIONS: Moderate-quality evidence indicates that use of a vapocoolant immediately before intravenous cannulation reduces pain during the procedure. Use of vapocoolant does not increase the difficulty of cannulation nor cause serious adverse effects but is associated with mild discomfort during application.

Development of an optimal sampling schedule for children receiving ketamine for short-term procedural sedation and analgesia.

BACKGROUND: Intravenous racemic ketamine is commonly administered for procedural sedation, although few pharmacokinetic studies have been conducted among children. Moreover, an optimal sampling schedule has not been derived to enable the conduct of pharmacokinetic studies that minimally inconvenience study participants. METHODS: Concentration-time data were obtained from 57 children who received 1-1.5 mg·kg(-1) of racemic ketamine as an intravenous bolus. A population pharmacokinetic analysis was conducted using nonlinear mixed effects models, and the results were used as inputs to develop a D-optimal sampling schedule. RESULTS: The pharmacokinetics of ketamine were described using a two-compartment model. The volume of distribution in the central and peripheral compartments were 20.5 l∙70 kg(-1) and 220 l∙70 kg(-1), respectively. The intercompartmental clearance and total body clearance were 87.3 and 87.9 l·h(-1) ∙70 kg(-1), respectively. Population parameter variability ranged from 34% to 98%. Initially, blood samples were drawn on 3-6 occasions spanning a range of 14-152 min after dosing. Using these data, we determined that four optimal sampling windows occur at 1-5, 5.5-7.5, 10-20, and 90-180 min after dosing. Monte Carlo simulations indicated that these sampling windows produced precise and unbiased ketamine pharmacokinetic parameter estimates. CONCLUSION: An optimal sampling schedule was developed that allowed assessment of the pharmacokinetic parameters of ketamine among children requiring short-term procedural sedation.

A qualitative analysis of how parents assess acute pain in young children.

An accurate and comprehensive pain assessment is crucial for adequate pain management in pre- and early verbal children during painful medical procedures. This study used an inductive approach to explore the processes involved in parental pain assessment and to develop a new model of Parental Assessment of Acute Child Pain. Participants were 19 parents of children aged under 3 years who had previously or were potentially about to experience an intravenous cannula or nasogastric tube insertion. Parental affect regulation, while witnessing their child in acute pain/distress, appeared to be critical to the processes involved in assessing their child's pain.

Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: In well-appearing children suspected of meningococcal disease can procalcitonin reduce the need for empiric antibiotic treatment?

A short-cut review of the literature was carried out to establish whether the biological marker procalcitonin could safely rule out the diagnosis of meningococcal disease (MCD) in children. Using the below outlined search method and after the exclusion of the non-relevant papers, two were found to be relevant to the specific question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these are shown in table 3. The clinical bottom line is that the currently available evidence is not sufficient to support the sole use of procalcitonin to rule out the diagnosis of MCD.

Exploring the pharmacokinetics of oral ketamine in children undergoing burns procedures.

AIMS: The aim of this study was to describe ketamine pharmacokinetics when administered orally to children suffering from burn injury in >10% body surface area. METHODS: Children (n = 20) were given ketamine 5 or 10 mg·kg(-1) orally 20 min prior to presentation for surgical procedures. Anesthesia during procedures was maintained with a volatile anesthetic agent. Additional intravenous ketamine was given as a bolus (0.5-1 mg·kg(-1)) to nine children during the procedure while a further nine children were given an infusion (0.1 mg·kg(-1)·h(-1)) continued for 4-19 h after the procedure. Blood was assayed for ketamine and norketamine on six occasions over the study duration of 8-24 h. Data were pooled with those from an earlier analysis (621 observations from 70 subjects). An additional time-concentration profile from an adult given oral ketamine was gleaned from the literature (17 observations). A population analysis was undertaken using nonlinear mixed-effects models. RESULTS: The pooled analysis comprised 852 observations from 91 subjects. There were 20 children who presented for procedures related to burns management (age 3.5 sd 2.1 years, range 1-8 years; weight 14.7 sd 4.9 kg, range 7.9-25 kg), and these children contributed 214 ketamine and norketamine observations. A two-compartment (central, peripheral) linear disposition model fitted data better than a one-compartment model. Bioavailability of the oral formulation was 0.45 (90% CI 0.33, 0.58). Absorption half-time was 59 (90% CI 29.4, 109.2) min and had high between-subject variability (BSV 148%). Population parameter estimates, standardized to a 70-kg person, were central volume 21.1 (BSV 47.1%) l·70 kg(-1), peripheral volume of distribution 109 (27.5%) l·70 kg(-1), clearance 81.3 (46.1%) l·h(-1)·70 kg(-1), and inter-compartment clearance 259 (50.1%) l·h(-1)·70 kg(-1). Under the assumption that all ketamine was converted to norketamine, the volume of the metabolite was 151.9 (BSV 39.1%) l·70 kg(-1) with an elimination clearance of 64.4 (BSV 63.4%) l·h(-1) ·70 kg(-1) and a rate constant for intermediate compartments of 26.2 (BSV 52.1%) h(-1)·70 kg(-1). CONCLUSIONS: The ketamine pharmacokinetics in children with minor burns are similar to those without burns. The peak ratio of norketamine/ketamine at 1 h is 2.8 after oral administration allowing an analgesic contribution from the metabolite at this time. There is low relative bioavailability (<0.5) and slow variable absorption. Dose simulation in a child (3.5 years, 15 kg) suggests a dose regimen of oral ketamine 10 mg·kg(-1) followed by intravenous ketamine 1 mg·kg(-1) i.v. with the advent of short-duration surgical dressing change at 45 min.

Cost benefit analysis of amethocaine (Ametop) compared with EMLA for intravenous cannulation in a children's emergency department.

INTRODUCTION: Starship Hospital Children's Emergency Department (CED) uses EMLA for topical anaesthesia during insertion of intravenous cannula (IVC). Amethocaine has recently been shown to offer more effective pain relief and work faster than EMLA, but may be more expensive. AIM: To determine cost implications of introducing topical amethocaine into CED practice. METHODS: Data were obtained from a randomised controlled trial, quality assurance project and an audit of topical anaesthetic use, with economic evaluation performed from the District Health Board perspective in 2007 NZ dollars and Euros. Proportion of children receiving topical anaesthetic cream during insertion of IVC was the primary benefit measure, and cost per child presenting to the department was the primary cost measure. A decision tree model was developed as a baseline, and sensitivity analysis was conducted. Multiple clinical scenarios were modelled, and incremental cost effectiveness ratios calculated compared to the baseline model. RESULTS: Scenarios modelled include providing no topical anaesthesia, using amethocaine exclusively or using a mixture of amethocaine and EMLA. All models are sensitive to the amount of cream applied at triage. The most cost effective model provided EMLA at triage to those most likely to need IVC; then amethocaine to other children later thought to require IVC. This model would cost NZ$1.05 per child, down from NZ$1.47. Proportion of children receiving cream during insertion of IVC would increase from 51% to 64%. The recommended model dominated the current situation. CONCLUSION: Use of amethocaine in a mixed model in the CED could reduce cost and increase the proportion of children receiving topical anaesthetic during insertion of IVC. Trial registration number Australian New Zealand Clinical Trials Register ACTRN12606000409572.

Pain management practices in paediatric emergency departments in Australia and New Zealand: a clinical and organizational audit by National Health and Medical Research Council's National Institute of Clinical Studies and Paediatric Research in Emergency Departments International Collaborative.

OBJECTIVE: To audit pain management practices and organization in paediatric ED across Australia and New Zealand. METHODS: Retrospective audit of pain management practices in Paediatric Research in Emergency Departments International Collaborative ED in 20 cases each of migraine, abdominal pain and femoral shaft fracture. Review of organizational status of pain management at Paediatric Research in Emergency Departments International Collaborative sites. RESULTS: Of 14 ED, 10 participated in the clinical audit. A total of 196 migraine, 197 abdominal pain and 177 femur fracture cases were reviewed. Less than half had degree of pain measured or had pain score documented on triage. Migraine received analgesia in 62% of cases (opioids in 11%). Abdominal pain received analgesia in 62% of cases (opioids in 14%). Fractured femurs received analgesia in 78% of cases (opioids 49%, femoral nerve blocks 40%). Median minutes to enteral medication were 100, 85 and 75, and for parenteral medication (mainly opiates) 103, 137 and 26, for migraine, abdominal pain and femur fracture, respectively. Thirteen hospitals participated in the organizational audit. Of all ED, 92% had pain management policies or guidelines, 92% taught pain management topics in education programmes and 62% used mandatory pain competencies. Only 15% had quality improvement programmes for pain reduction. CONCLUSION: We found a notable lack of pain assessment documentation and delays to analgesia. There is a need to improve pain assessment and management, although a majority of paediatric ED surveyed had important organizational and educational structures in place. Issues to explore include use of opioids in migraine and the underuse of femoral nerve blocks.

Anxiety in children undergoing VCUG: sedation or no sedation?

BACKGROUND: Voiding cystourethrograms are distressing for children and parents. Nonpharmacological methods reduce distress. Pharmacological interventions for VCUG focus on sedation as well as analgesia, anxiolysis, and amnesia. Sedation has cost, time, and safety issues. Which agents and route should we use? Are we sure that sedation does not influence the ability to diagnose vesicoureteric reflux? METHODS: Literature search of Medline, EMBASE, and the Cochrane Database. Review of comparative studies found. RESULTS: Seven comparative studies including two randomised controlled trials were reviewed. Midazolam given orally (0.5-0.6 mg/kg) or intranasally (0.2 mg/kg) is effective with no apparent effect on voiding dynamics. Insufficient evidence to recommend other sedating agents was found. Deeper sedating agents may interfere with voiding dynamics. CONCLUSION: Midazolam reduces the VCUG distress, causes amnesia, and does not appear to interfere with voiding dynamics. Midazolam combined with simple analgesia is an effective method to reduce distress to children undergoing VCUG.

Ketamine anesthesia in children--exploring infusion regimens.

AIM: We aimed to produce a racemic ketamine manual infusion regimen capable of maintaining a steady-state blood concentration associated with anesthesia in children aged 1.5-12 years. METHOD: The literature was searched for a ketamine blood concentration associated with anesthesia in humans. Pharmacokinetic parameter estimates were taken from published studies of infusion data in children and used in a pharmacokinetic simulation program to predict likely ketamine blood concentrations during infusions. A variability of 10% was allowed about the chosen target concentration. RESULTS: A target concentration of 3 mg.l(-1) was chosen for simulation modeling. This target is greater than that associated with anesthesia when supplemented by nitrous oxide or midazolam in adults. Arousal to light touch or voice appears to occur at a mean plasma concentration of 0.5 mg.l(-1) in both children and adults. A loading dose of 2 mg.kg(-1) followed by an infusion rate of 11 mg.kg(-1).h(-1) for the first 20 min, 7 mg.kg(-1).h(-1) from 20 to 40 min, 5 mg.kg(-1).h(-1) from 40 to 60 min and 4 mg.kg(-1).h(-1) from 1 to 2 h resulted in a steady-state target concentration of 3 mg.l(-1) in children 1.5-12 years. Arousal, either spontaneous or to speech, is anticipated 3 h 47 min after a 2 h infusion in an average 6-year-old child. The context sensitive half-time in children was shorter than in adults after 1.5 h, rising from 30 min at 1 h to 55 min at 5 h after an infusion of 3 mg.kg(-1).h(-1) in a 10 kg child. CONCLUSION: Children require higher infusion rates than adults to maintain steady-state concentrations of 3 mg.l(-1) and have shorter context sensitive half-times than adults after prolonged infusion. These differences can be attributed to age-related pharmacokinetics. We anticipate slow return to full consciousness after prolonged infusion, suggesting that a lower target concentration with supplementation from adjuvant short acting anesthetic drugs may be advantageous.

Dosing ketamine for pediatric procedural sedation in the emergency department.

OBJECTIVE: To describe intravenous ketamine dosing regimens for children requiring brief procedural sedation. METHODS: Time-concentration and sedation profiles were simulated in children (2, 6, and 12 years old) using published pediatric pharmacokinetic and pharmacodynamic parameter estimates. Single-dose, repeat-dosing, and infusion regimens to achieve sedation level of less than 2 (arouses slowly to consciousness, with sustained painful stimulus) for 15 minutes were investigated. RESULTS: A single bolus dose of 1.5 and 1.75, 2, and 2.125 mg/kg (for adult and 12-, 6-, and 2-year-olds, respectively) was required to achieve the desired sedation. Anticipated recovery would be slow, and a sedation level of 4 (drowsy, eyes open or closed but easily arouses to consciousness with verbal stimulus) was reached only after 70 minutes. The use of a smaller initial bolus with a subsequent half-dose "top-up" at 8 minutes achieves the same sedation level but with earlier recovery. A smaller initial dose of 0.25 and 0.275, 0.3, and 0.35 mg/kg followed by an infusion 2.5 and 2.75, 3, and 3.5 mg/kg per hour (for adult and 12-, 6-, and 2-year-olds, respectively) for 15 minutes gives a more even sedation level and rapid recovery (20 minutes to sedation level 4). CONCLUSIONS: Dosing increases with decreasing age. A large single dose is associated with deep sedation, possible adverse effects, and delayed recovery. Between-subjects variability is large, and dose should be tailored to clinical monitoring and requirement. Intermittent pain insult is better suited to a top-up technique, whereas continuous pain is better suited to an infusion technique.