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1.
Pediatr Neurol ; 153: 44-47, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38320457

ABSTRACT

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.


Subject(s)
Bell Palsy , Facial Paralysis , Child , Humans , Prednisolone/therapeutic use , Bell Palsy/diagnosis , Bell Palsy/drug therapy , Treatment Outcome , Parents
2.
Arch Dis Child ; 109(3): 227-232, 2024 02 19.
Article in English | MEDLINE | ID: mdl-38049992

ABSTRACT

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.


Subject(s)
Bell Palsy , Facial Paralysis , Pain , Humans , Bell Palsy/complications , Bell Palsy/drug therapy , Bell Palsy/epidemiology , Facial Paralysis/drug therapy , Pain/drug therapy , Pain/epidemiology , Pain/etiology , Prednisolone/therapeutic use , Clinical Trials, Phase III as Topic , Randomized Controlled Trials as Topic , Infant , Child, Preschool , Child , Adolescent
3.
OTO Open ; 7(1): e44, 2023.
Article in English | MEDLINE | ID: mdl-36998545

ABSTRACT

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.

4.
Neurology ; 2022 Aug 25.
Article in English | MEDLINE | ID: mdl-36008143

ABSTRACT

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.

5.
J Paediatr Child Health ; 58(4): 624-629, 2022 04.
Article in English | MEDLINE | ID: mdl-34694041

ABSTRACT

AIM: The risk of serious illness in febrile infants (<60 days old) is high, and so fever often warrants aggressive management. Infrared thermometers are unreliable in young infants despite their ubiquity. We aim to describe the: (i) frequency of infrared thermometer usage; (ii) progression to documented fever in the emergency department (ED) and (iii) rate of serious illness (meningitis, urinary tract infection and bacteremia). METHODS: In this single-centre retrospective chart review at The Royal Children's Hospital, Melbourne, we audited medical records of infants (<60 days old) presenting to the ED with pre-hospital fever on history over a 12-month period. We described the type of thermometer used at home (tympanic or forehead, 'infrared' vs. axillary or rectal, 'direct') correlated to peak temperature in ED, investigations, treatment and diagnosis. The primary outcome was subsequent fever in ED. RESULTS: Of 159 infants, two of three had infrared temperature measurement at home. Fifty-one (32.1%) developed fever in ED (direct 28/54, 52% vs. infrared 23/105, 22% RR 2.36 (95% CI 1.52-3.69)). Investigations (75%) and admission (60%) were common. Pre-hospital fever alone was less likely to be associated with serious illness, with fever in ED a much stronger predictor. CONCLUSIONS: In young infants, infrared thermometer use is common and less likely to predict subsequent fever. Twenty-two percent of infants with fever via infrared measurement had fever in ED. History of fever without confirmation is less likely to signal serious illness. Education to public and health-care providers is required to avoid usage of infrared devices in this population.


Subject(s)
Body Temperature , Thermometers , Child , Fever/diagnosis , Fever/etiology , Humans , Infant , Retrospective Studies , Sensitivity and Specificity
6.
Emerg Med Australas ; 34(1): 120-121, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34704359

ABSTRACT

OBJECTIVE: Intraosseous (IO) needle insertion is an effective method to obtain circulatory access in unwell children. METHODS: We conducted a 12-month retrospective record review of children aged less than 18 years who had a recorded IO attempt by Ambulance Victoria paramedics. RESULTS: Sixty-five children underwent IO attempt during pre-hospital care, 60 had IO outcome recorded and were included. 58/60 (96.7%) children had IO successfully placed, 35 were aged <5 years. Cardiorespiratory arrest (39/58, 67.2%) and status epilepticus (11/58, 19%) were the most common indications. CONCLUSION: While IO placement is uncommonly performed pre-hospital, in critical situations there is a high success rate.


Subject(s)
Emergency Medical Services , Heart Arrest , Adolescent , Child , Child, Preschool , Emergency Medical Services/methods , Hospitals , Humans , Infusions, Intraosseous/methods , Retrospective Studies
7.
Am J Emerg Med ; 50: 59-65, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34280709

ABSTRACT

INTRODUCTION: Forearm fractures are common pediatric injuries. Most displaced or angulated fractures can be managed via closed reduction in the operating room or in the Emergency Department (ED). Previous research has shown that emergency physicians can successfully perform closed reduction within ED; however, the fracture morphology amendable to ED physician reduction is unclear. The aim of this study is to detail the fracture characteristics associated with successful reduction by ED physicians. METHODS: We conducted a retrospective study of children (aged <18 years) presenting to the ED of a tertiary care children's hospital (annual census 90,000) between January 2018 and December 2018 with closed distal and midshaft forearm fractures requiring reduction. Data collected included patient demographics, fracture morphology, management, and complications. Successful ED physician reduction was based on predefined criteria. Orthopedic referrals included those patients sent directly to the operating room, closed reductions performed by orthopedic trainees within the ED, and patients requiring orthopedic consultation after failed ED reduction. RESULTS: A total of 340 patients with forearm fractures were included in the study. ED clinicians attempted to reduce 274 (80.6%) of these fractures and were successful in 256/274 (93.4%) cases. Of the 84 orthopedic referrals, 18 were after failed ED clinician attempt, and 66 were ab initio managed by orthopedics (37 in the operating room and 29 in ED). Compared to the fractures with successful ED reduction (n = 256), factors associated with orthopedic referral (n = 84) included: increasing age, midshaft location, higher degree of angulation, and completely displaced fractures. Angulated distal greenstick fractures were most likely to be successfully reduced by ED clinicians. There were no difference in complication rates between the two groups. CONCLUSION: In this series, fractures most amenable to reduction by ED clinicians include distal greenstick fractures, whereas midshaft and completely displaced fractures are more likely to need treatment by orthopedics.


Subject(s)
Closed Fracture Reduction , Emergency Service, Hospital , Radius Fractures/therapy , Ulna Fractures/therapy , Adolescent , Child , Child, Preschool , Female , Humans , Infant , Male , Referral and Consultation/statistics & numerical data , Retrospective Studies
8.
Arch Dis Child ; 106(9): 896-899, 2021 09.
Article in English | MEDLINE | ID: mdl-33419726

ABSTRACT

BACKGROUND: Preseptal cellulitis can be difficult to distinguish from orbital cellulitis in children. The majority of patients with periorbital infections are admitted for intravenous antibiotics. This study aimed to investigate the risk of missing orbital cellulitis and the outcomes of missed patients. METHODS: A prospective cohort study of children aged 3 months to 18 years diagnosed with preseptal cellulitis over 5 years. Data were collected prospectively, including demographics, clinical features and outcomes. RESULTS: There were 216 children diagnosed with preseptal cellulitis. 75 (35%) were treated with oral antibiotics and 141 (65%) with intravenous antibiotics. 5 (2%) children who were hospitalised were subsequently determined to have orbital cellulitis. All 5 children were either a young infant with difficult eye examination, or had headache or vomiting. CONCLUSION: The risk of missing orbital cellulitis is low. Young infants with difficult eye examination or the presence of headache or vomiting should increase suspicion of orbital cellulitis.


Subject(s)
Cellulitis/diagnosis , Eyelids/pathology , Missed Diagnosis/adverse effects , Orbital Cellulitis/diagnosis , Administration, Intravenous , Administration, Oral , Adolescent , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Cellulitis/drug therapy , Child , Child, Preschool , Female , Headache/diagnosis , Headache/etiology , Hospitalization , Humans , Infant , Male , Missed Diagnosis/statistics & numerical data , Orbital Cellulitis/drug therapy , Prospective Studies , Risk Assessment , Treatment Outcome , Vomiting/diagnosis , Vomiting/etiology
9.
Emerg Med J ; 37(6): 345-350, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32245749

ABSTRACT

OBJECTIVE: To compare the treatment practices (immobilisation vs non-immobilisation) of toddler fractures and other minor tibial fractures (both proven and suspected) in preschoolers, aged 9 months-4 years, and examine rates of ED re-presentations and complications. METHODS: Retrospective chart review of presentations of minor tibial fractures, both proven (radiologically confirmed) or suspected (negative X-ray but clinical evidence of bony injury), in children aged 9 months-4 years presenting to a single tertiary level paediatric ED from May 2016 to April 2018. Data collected included treatment practices, subsequent unscheduled re-presentations (including reasons) and complications (defined as problems relating to the injury that required further active care). RESULTS: A search of medical records yielded 240 cases: 102 had proven fractures (spiral, buckle or Salter-Harris II) and 138 were diagnosed with a suspected fracture. 73.5% of proven fractures were immobilised, predominantly with backslabs. 79% of suspected fractures were treated with expectant observation without immobilisation. Patients treated with immobilisation were more likely to re-present to ED compared with non-immobilised patients (18/104, 17.3% vs 9/136, 6.6% RR 2.62, 95% CI 1.23 to 5.58). 21 complications were seen in 19/104 (18.3%) immobilised patients. There were eight skin complications (complication rate of 7.7%) and 11 cast issues (complication rate of 10.6%). Two (1.5%) of the 136 patients had complications related to pain or limp. Pain was uncommonly found, although follow-up was not universal. CONCLUSION: In our centre, proven minor tibial fractures were more likely to receive a backslab, whereas for suspected fractures, expectant observation without immobilisation was performed. Although there is potential bias in the identification of complications with immobilisation, the study suggests that non-immobilisation approach should be investigated.


Subject(s)
Immobilization/standards , Radiography/statistics & numerical data , Tibial Fractures/complications , Child, Preschool , Female , Humans , Immobilization/methods , Immobilization/statistics & numerical data , Infant , Male , Radiography/methods , Retrospective Studies , Tibial Fractures/therapy
10.
Ann Emerg Med ; 75(6): 735-743, 2020 06.
Article in English | MEDLINE | ID: mdl-31983494

ABSTRACT

STUDY OBJECTIVE: Intranasal fentanyl and inhaled nitrous oxide are increasingly combined to provide procedural sedation and analgesia in the pediatric emergency setting. This regimen is attractive because of its nonparenteral administration, but is associated with a higher incidence of vomiting than nitrous oxide alone. We seek to assess whether prophylactic oral ondansetron use could reduce the incidence of vomiting associated with intranasal fentanyl and nitrous oxide for procedural sedation compared with placebo. METHODS: This was a double-blind, randomized controlled trial of oral ondansetron versus placebo conducted at a single tertiary care pediatric emergency department. Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide were randomized to receive oral ondansetron or placebo 30 to 60 minutes before nitrous oxide administration. The primary outcome was early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration. Secondary outcomes included vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups. RESULTS: We recruited 442 participants and 436 were included for analysis. There was no significant difference in the primary outcome, early vomiting associated with procedural sedation, between the groups: ondansetron 12% versus placebo 16%, with a difference in proportions of -4.6% (95% confidence interval -11% to 2.0%; P=.18). Most sedations were reported as optimal by treating clinicians (91%). Only 2 minor adverse events occurred, both in the placebo group. CONCLUSION: Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.


Subject(s)
Analgesics/administration & dosage , Antiemetics/administration & dosage , Fentanyl/administration & dosage , Nitrous Oxide/administration & dosage , Ondansetron/administration & dosage , Vomiting/drug therapy , Administration, Intranasal , Administration, Oral , Adolescent , Analgesics/adverse effects , Antiemetics/therapeutic use , Child , Child, Preschool , Female , Fentanyl/adverse effects , Humans , Male , Nitrous Oxide/adverse effects , Ondansetron/therapeutic use , Tertiary Care Centers , Treatment Outcome , Vomiting/chemically induced
11.
Emerg Med Australas ; 32(1): 93-99, 2020 02.
Article in English | MEDLINE | ID: mdl-31317676

ABSTRACT

OBJECTIVES: While cervical spine injuries (CSIs) are rare in the paediatric population, presentations to EDs with possible neck injuries are common. Based on a lack of Australian data we set out to determine how many possible injuries are clinically cleared, what imaging is used on the remainder and the incidence and characteristics of confirmed paediatric CSIs. METHODS: We undertook a retrospective electronic medical record review of children <18 years with potential CSIs at a large tertiary paediatric trauma centre in Victoria, Australia over a 12 month period (annual census 87 000). For possible injuries we extracted key epidemiologic, imaging and short-term outcome data. RESULTS: During the study period, a total of 617 patients with potential neck injuries were seen in the ED (617/87 000, 0.7%). The median age was 11 years. The most common mechanisms of injury were falls (41%), motor vehicle injuries (28%) and sports-related injuries (24%). Four hundred and fourteen of 617 (67%) underwent neck imaging (345/414, 83% plain radiograph; 100/414, 24% computed tomography; 7/414, 1.6% magnetic resonance imaging). Twenty-three of 617 (4.1%) had radiologically documented CSIs. Two required operative interventions for their neck injuries. CONCLUSION: While two-thirds of children with potential CSIs undergo radiological evaluation, actual injuries are rare (<4%). These data suggest that there is a potential for improved targeting of cervical spine imaging for trauma. The development of a clinical decision tool may help reduce neck radiography.


Subject(s)
Cervical Vertebrae/injuries , Neck Injuries/diagnostic imaging , Spinal Injuries/diagnostic imaging , Trauma Centers , Child , Child, Preschool , Female , Humans , Infant , Male , Retrospective Studies , Victoria
13.
Lancet Infect Dis ; 19(10): 1101-1108, 2019 10.
Article in English | MEDLINE | ID: mdl-31420292

ABSTRACT

BACKGROUND: Outpatient parenteral antibiotic therapy after hospital admission is increasingly popular, but its use to avoid admission to hospital altogether by treating patients wholly as outpatients remains uncommon in children. One reason for the low use of treatment at home is the scarcity of evidence of its cost-effectiveness. In this planned follow-up analysis of the Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial, we aimed to assess the cost-effectiveness of an admission avoidance pathway, in which children were treated at home, compared with standard hospital care for the intravenous treatment of moderate or severe cellulitis. METHODS: We did a cost-effectiveness analysis to compare home treatment with intravenous ceftriaxone versus hospital treatment with intravenous flucloxacillin in children aged 6 months to 18 years who had presented to the emergency department at The Royal Children's Hospital, Melbourne, VIC, Australia, with moderate or severe uncomplicated cellulitis. We included costs from two sources: institutional costs at a patient level and expenses incurred by families. We measured effectiveness with quality-adjusted life years (QALYs), which we derived from the Child Health Utility 9D questionnaire, and a clinical outcome of treatment failure, which was the primary outcome of the CHOICE trial. We planned to calculate the incremental cost-effectiveness ratio, defined as the difference between groups in total cost divided by the difference between groups in effectiveness. The CHOICE trial is registered at ClinicalTrials.gov, number NCT02334124. FINDINGS: We included 180 children who comprised the per-protocol population in the CHOICE trial: 89 children in the home group and 91 children in the hospital group. The institutional cost per patient per episode was significantly lower in the home group than in the hospital group (AUS$1965 vs $3775; p<0·0001). The mean cost incurred per family was $182 for the home group and $593 for the hospital group (p<0·0001). Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029). Calculating the incremental cost-effectiveness ratio was thus deemed redundant. INTERPRETATION: Treatment at home was less costly and more effective than standard hospital care for children with moderate or severe cellulitis. These findings support development of this admission avoidance pathway in hospitals. FUNDING: The Royal Children's Hospital Foundation, Murdoch Children's Research Institute.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Ceftriaxone/therapeutic use , Cellulitis/drug therapy , Cost-Benefit Analysis/methods , Floxacillin/therapeutic use , Home Care Services/economics , Hospitalization/economics , Administration, Intravenous , Adolescent , Anti-Bacterial Agents/administration & dosage , Australia , Ceftriaxone/administration & dosage , Child , Child, Preschool , Emergency Service, Hospital , Female , Floxacillin/administration & dosage , Follow-Up Studies , Humans , Infant , Male , Quality-Adjusted Life Years , Treatment Failure
14.
J Pediatr ; 209: 160-167.e4, 2019 06.
Article in English | MEDLINE | ID: mdl-31047650

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of a virtual reality distraction for needle pain in 2 common hospital settings: the emergency department (ED) and outpatient pathology (ie, outpatient laboratory). The control was standard of care (SOC) practice. STUDY DESIGN: In 2 clinical trials, we randomized children aged 4-11 years undergoing venous needle procedures to virtual reality or SOC at 2 tertiary Australian hospitals. In the first study, we enrolled children in the ED requiring intravenous cannulation or venipuncture. In the second, we enrolled children in outpatient pathology requiring venipuncture. In the ED, 64 children were assigned to virtual reality and 59 to SOC. In pathology, 63 children were assigned to virtual reality and 68 to SOC; 2 children withdrew assent in the SOC arm, leaving 66. The primary endpoint was change from baseline pain between virtual reality and SOC on child-rated Faces Pain Scale-Revised. RESULTS: In the ED, there was no change in pain from baseline with SOC, whereas virtual reality produced a significant reduction in pain (between-group difference, -1.78; 95% CI, -3.24 to -0.317; P = .018). In pathology, both groups experienced an increase in pain from baseline, but this was significantly less in the virtual reality group (between-group difference, -1.39; 95% CI, -2.68 to -0.11; P = .034). Across both studies, 10 participants experienced minor adverse events, equally distributed between virtual reality/SOC; none required pharmacotherapy. CONCLUSIONS: In children aged 4-11 years of age undergoing intravenous cannulation or venipuncture, virtual reality was efficacious in decreasing pain and was safe. TRIAL REGISTRATION: Australia and New Zealand Clinical Trial Registry: ACTRN12617000285358p.


Subject(s)
Catheterization/adverse effects , Needles/adverse effects , Pain, Procedural/etiology , Pain, Procedural/prevention & control , Phlebotomy/adverse effects , Virtual Reality , Child , Child, Preschool , Female , Humans , Male , Treatment Outcome
15.
Lancet Infect Dis ; 19(5): 477-486, 2019 05.
Article in English | MEDLINE | ID: mdl-30853250

ABSTRACT

BACKGROUND: Outpatient parenteral antimicrobial therapy in children is common despite no evidence of its efficacy or safety from clinical trials. We aimed to compare the efficacy and safety of intravenous antibiotic therapy at home with that of standard treatment in hospital for children with moderate to severe cellulitis. METHODS: The Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial was a randomised, controlled, non-inferiority trial in children aged 6 months to 18 years who presented to the emergency department at The Royal Children's Hospital (Melbourne, VIC, Australia) with uncomplicated moderate to severe cellulitis. Participants were randomly assigned to receive either intravenous ceftriaxone (50 mg/kg once daily) at home or intravenous flucloxacillin (50 mg/kg every 6 h) in hospital with web-based randomisation, stratified by age and periorbital cellulitis. The primary outcome was treatment failure, which was defined as no clinical improvement or occurrence of an adverse event, resulting in a change in empiric antibiotics within 48 h of the first dose. Secondary outcomes included adverse events and acquisition of antibiotic-resistant bacteria. Outcomes were assessed in all randomised participants with outcome data (intention-to-treat population) and in all individuals who received treatment as allocated and did not have any major protocol violations (per-protocol population). For home treatment to be non-inferior to hospital treatment, the difference between groups in the proportion of children with treatment failure in the intention-to-treat population had to be less than 15%. This trial is registered with ClinicalTrials.gov, number NCT02334124. FINDINGS: Between Jan 9, 2015, and June 15, 2017, we screened 1135 children for eligibility, of whom 190 were randomly assigned to receive ceftriaxone at home (n=95) or flucloxacillin in hospital (n=95). The intention-to-treat analysis comprised 188 children (93 in the home group and 95 in the hospital group) because two children in the home group were found to be ineligible after randomisation and were excluded. Treatment failure occurred in two (2%) children in the home group and in seven (7%) children in the hospital group (risk difference -5·2%, 95% CI -11·3 to 0·8, p=0·088). In the per-protocol analysis, treatment failure occurred in one (1%) of 89 children in the home group and in seven (8%) of 91 children in the hospital group (-6·5%, -12·4 to -0·7). Fewer children treated at home than in hospital had an adverse event (two [2%] vs ten [11%]; p=0·048). There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum ß-lactamase-producing bacteria or Clostridium difficile after 3 months. INTERPRETATION: Home treatment with intravenous ceftriaxone is not inferior to treatment in hospital with intravenous flucloxacillin for children with cellulitis. The standard of care for the intravenous treatment of uncomplicated cellulitis in children should be home or outpatient care when feasible. FUNDING: The Royal Children's Hospital Foundation and Murdoch Children's Research Institute.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Ceftriaxone/administration & dosage , Cellulitis/drug therapy , Floxacillin/administration & dosage , Home Care Services, Hospital-Based , Hospitalization , Administration, Intravenous , Adolescent , Anti-Bacterial Agents/adverse effects , Australia , Ceftriaxone/adverse effects , Child , Child, Preschool , Emergency Service, Hospital , Female , Floxacillin/adverse effects , Hospitals , Humans , Infant , Male , Treatment Outcome
16.
Pediatrics ; 143(2)2019 02.
Article in English | MEDLINE | ID: mdl-30606746

ABSTRACT

: media-1vid110.1542/5972298232001PEDS-VA_2018-1420Video Abstract BACKGROUND: The evidence is unclear about the optimal route of treatment for children with cellulitis, specifically how to assess the risk of moderate-to-severe cellulitis requiring intravenous (IV) antibiotics. We aimed to derive and validate a cellulitis risk assessment scoring system to guide providers as to which patients require IV antibiotics. METHODS: This was a prospective cohort study of children presenting to the emergency department aged 6 months to 18 years diagnosed with cellulitis from January 2014 to August 2017. Patients were divided into 2 groups based on route of antibiotics at 24 hours (the predetermined gold standard). Demographics and clinical features were compared. Clinicians were surveyed about which features they used to decide whether to start IV antibiotics. Combinations of differentiating features were plotted on receiver operating characteristic curves. RESULTS: There were 285 children in the derivation cohort used to create the Melbourne Area, Systemic features, Swelling, Eye, Tenderness (ASSET) Score, which has a maximum score of 7. The area under the curve was 0.86 (95% confidence interval 0.83-0.91). Using a cutoff score of 4 to start IV antibiotics yielded the highest correct classification of 80% of patients (sensitivity 60%; specificity 93%). This score was validated in 251 children and maintained a robust area under the curve of 0.83 (95% confidence interval 0.78-0.89). CONCLUSIONS: The Melbourne ASSET Score was derived and validated for cellulitis in children to guide clinicians regarding when to start IV antibiotics. Although intended for widespread use, if limitations exist in other settings, it is designed to allow for refinement and is amenable to local impact analysis.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Cellulitis/diagnosis , Cellulitis/drug therapy , Emergency Service, Hospital/standards , Severity of Illness Index , Adolescent , Child , Child, Preschool , Cohort Studies , Emergency Service, Hospital/trends , Female , Follow-Up Studies , Humans , Infant , Male , Prospective Studies , Reproducibility of Results , Risk Assessment/methods
17.
Pediatr Infect Dis J ; 38(2): e20-e25, 2019 02.
Article in English | MEDLINE | ID: mdl-29634622

ABSTRACT

BACKGROUND: Outpatient parenteral antimicrobial therapy offers the option of treating children requiring intravenous antibiotics for acute urinary tract infection (UTI)/pyelonephritis at home. We aimed to determine the outcomes of treating patients with UTI/pyelonephritis using outpatient parenteral antimicrobial therapy directly from the emergency department (ED) without admission to hospital. METHODS: This was a retrospective study (August 2012-July 2016) of children with UTI/pyelonephritis treated with parenteral antibiotics via a peripheral cannula directly from ED to home under a hospital-in-the home (HITH) program. Data collection included demographics, clinical features, length of stay, complications, and readmissions to hospital. RESULTS: There were 62 patient episodes of UTI/pyelonephritis transferred directly from ED to HITH. Fifty-eight (94%) had systemic features including fever, vomiting and/or tachycardia. Eighteen (29%) patients had an underlying condition. Nine (15%) received intravenous fluids and 8 (13%) antiemetics in ED. The outpatient parenteral antimicrobial therapy course was successfully completed in 56 (90%) patients. Of 6 (10%) patients who were readmitted, 2 were discharged within 24 hours, and none were severely unwell. Two (3%) had a blocked cannula, with no antibiotic complications. HITH patients were treated for a combined total of 142 days at home resulting in a cost saving of Australian dollar 108,914 (US dollar 82,775). However, only 8% of children deemed to require a course of intravenous antibiotics were transferred directly home from ED. Compared with patients concurrently admitted to hospital, fewer on HITH were less than 1 year of age (13% vs. 33%; odds ratio: 0.3; P < 0.01). CONCLUSIONS: Selected patients presenting to ED with UTI/pyelonephritis may be treated directly via HITH, including some with underlying conditions and/or systemic features.


Subject(s)
Administration, Intravenous , Anti-Bacterial Agents/therapeutic use , Emergency Service, Hospital , Urinary Tract Infections/drug therapy , Acute Disease , Adolescent , Child , Child, Preschool , Female , Humans , Infant , Male , Outpatients , Pyelonephritis/drug therapy , Retrospective Studies
18.
BMJ Paediatr Open ; 2(1): e000218, 2018.
Article in English | MEDLINE | ID: mdl-29637190

ABSTRACT

INTRODUCTION: Intranasal fentanyl and nitrous oxide (N2O) can be combined to create a non-parenteral procedural sedation regimen for children in the paediatric emergency department. This combination of intranasal fentanyl and N2O provides effective pain relief for more painful procedures, but is associated with a higher incidence of vomiting than N2O alone. Our aim is to assess whether ondansetron used preventatively reduces the incidence of vomiting associated with intranasal fentanyl and N2O for procedural sedation compared with placebo. METHODS AND ANALYSIS: This study is a double blind, randomised placebo-controlled superiority trial. This is a single-centre trial of 442 children aged 3-18 years presenting to a tertiary care Paediatric Emergency Department at the Royal Children's Hospital (RCH), Melbourne, Australia, requiring procedural sedation with intranasal fentanyl and N2O. After written consent, eligible participants are randomised to receive ondansetron or placebo along with intranasal fentanyl, 30-60 min prior to N2O administration. The primary outcome is vomiting during or up to 1 hour after procedural sedation. Secondary outcomes include: number of vomits and retching during procedural sedation, vomiting 1-24 hours after procedural sedation, procedural sedation duration and associated adverse events, procedure abandonment, parental satisfaction and the value parents place on the prevention of vomiting. This trial will allow refinement of a non-parenteral sedation regimen for children requiring painful procedures. ETHICS AND DISSEMINATION: This study has ethics approval at the RCH, Melbourne, protocol number 36174. The results from this trial will be submitted to conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12616001213437).

19.
Emerg Med J ; 34(12): 780-785, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28978652

ABSTRACT

OBJECTIVE: Children with moderate/severe cellulitis requiring intravenous antibiotics are usually admitted to hospital. Admission avoidance is attractive but there are few data in children. We implemented a new pathway for children to be treated with intravenous antibiotics at home and aimed to describe the characteristics of patients treated on this pathway and in hospital and to evaluate the outcomes. METHODS: This is a prospective, observational cohort study of children aged 6 months-18 years attending the ED with uncomplicated moderate/severe cellulitis in March 2014-January 2015. Patients received either intravenous ceftriaxone at home or intravenous flucloxacillin in hospital based on physician discretion. Primary outcome was treatment failure defined as antibiotic change within 48 hours due to inadequate clinical improvement or serious adverse events. Secondary outcomes include duration of intravenous antibiotics and complications. RESULTS: 115 children were included: 47 (41%) in the home group and 68 (59%) in the hospital group (59 hospital-only, 9 transferred home during treatment). The groups had similar clinical features. 2/47 (4%) of the children in the home group compared with 8/59 (14%) in the hospital group had treatment failure (P=0.10). Duration of intravenous antibiotics (median 1.9 vs 1.8 days, P=0.31) and complications (6% vs 10%, P=0.49) were no different between groups. Home treatment costs less, averaging $A1166 (£705) per episode compared with $A2594 (£1570) in hospital. CONCLUSIONS: Children with uncomplicated cellulitis may be able to avoid hospital admission via a home intravenous pathway. This approach has the potential to provide cost and other benefits of home treatment.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Ceftriaxone/therapeutic use , Cellulitis/drug therapy , Emergency Service, Hospital/statistics & numerical data , Floxacillin/therapeutic use , Home Infusion Therapy , Patient Admission/statistics & numerical data , Adolescent , Anti-Bacterial Agents/administration & dosage , Ceftriaxone/administration & dosage , Child , Child, Preschool , Female , Floxacillin/administration & dosage , Humans , Infant , Infusions, Intravenous , Male , Prospective Studies , Treatment Outcome
20.
J Paediatr Child Health ; 53(10): 970-975, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28618045

ABSTRACT

AIM: Clean catch urine (CCU) collection is commonly used in pre-continent children. CCU can be time-consuming and specimens may be contaminated. Our aim was to determine the time taken for CCU attempts and to describe the success of this method in diagnosing or excluding urinary tract infection. METHODS: Prospective observational study of CCU in pre-continent children aged 2-48 months in the emergency department. Time taken until urine collection, 'successful' (voided and caught), 'missed' (voided not caught) or the procedure 'stopped', were recorded and urine culture results analysed. RESULTS: Two hundred and seventeen children (131 (60%) male) were enrolled. There were a total of 247 attempts at CCU. For the first attempt, the median collecting time was 30.5 min (interquartile range (IQR) 11-66). Outcome was 'successful' in 64% (95% confidence intervals (CI) 58-70%), 'missed' in 16% (95% CI 11-20%) and 'stopped' in 20% (95% CI 15-26%). Median time if 'successful' was 25 min (IQR 7-46.5), 'missed' 27 min (IQR 11.6-59) and 71 min (IQR 42.5-93) when 'stopped'. One hundred and sixty children had successful CCU collection, 129 were sent for culture. Fifty of 129 (39%) cultures were contaminated. If all urine specimens caught were sent for culture, the estimated yield of an uncontaminated urine specimen was 45%. Contamination was not related to time taken for CCU. CONCLUSIONS: CCU is time-consuming, frequently unsuccessful and contaminated, resulting in a low overall diagnostic yield. Clinicians could expect a 45% chance of obtaining a definitive urine sample from this method overall.


Subject(s)
Urinary Tract Infections/diagnosis , Urine Specimen Collection/methods , Child, Preschool , Female , Humans , Infant , Male , Prospective Studies , Specimen Handling , Time Factors
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