RESUMEN
INTRODUCTION: Acute pain is the most common symptom in the emergency setting and its optimal management continues to challenge prehospital emergency care practitioners, particularly in the paediatric population. Difficulty in establishing vascular access and fear of opiate administration to small children are recognized reasons for oligoanalgesia. Intranasal fentanyl (INF) has been shown to be as safe and effective as intravenous morphine in the treatment of severe pain in children in the Emergency Department setting. AIM: This study aimed to describe the clinical efficacy and safety of INF when administered by advanced paramedics in the prehospital treatment of acute severe pain in children. METHODS: A 1-year prospective cross-sectional study was carried out of children (>1 year, <16 years) who received INF as part of the prehospital treatment of acute pain by the statutory national emergency medical services in Ireland. RESULTS: Ninety-four children were included in the final analysis [median age 11 years (interquartile range 7-13)]; 53% were males and trauma was implicated in 86% of cases. A clinically effective reduction in the pain score was found in 78 children [83% (95% confidence interval: 74-89%)]. The median initial pain rating score was 10. Pain assessment at 10 min after INF administration indicated a median pain rating of 5 (interquartile range 2-7). No patient developed an adverse event as a result of INF. DISCUSSION: INF at a dose of 1.5 µg/kg appears to be a safe and effective analgesic in the prehospital management of acute severe pain in children and may be an attractive alternative to both oral and intravenous opiates.
Asunto(s)
Dolor Agudo/tratamiento farmacológico , Analgésicos Opioides/administración & dosificación , Servicio de Urgencia en Hospital , Fentanilo/administración & dosificación , Dimensión del Dolor , Administración Intranasal , Factores de Edad , Niño , Preescolar , Intervalos de Confianza , Estudios Transversales , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Estudios de Seguimiento , Humanos , Lactante , Irlanda , Masculino , Estudios Prospectivos , Medición de Riesgo , Estadísticas no Paramétricas , Resultado del TratamientoRESUMEN
INTRODUCTION: There is extensive literature on paediatric procedural sedation (PPS) and its clinical applications in emergency departments (EDs). While numerous guidance and policy documents exist from international bodies, there remains a lack of uniformity and consistency of PPS practices within EDs. PPS is now gaining traction in the UK and Ireland and this study aimed to describe existing PPS practices and identify any challenges to training and provision of ED-based PPS. METHODS: A qualitative approach was employed to capture data through a focus group interview. Nine consultants in emergency medicine (EM) participated, varying in years of experience, clinical settings (mixed adult and paediatric ED or paediatric only) and geographical location (UK and Ireland). The focus group was audio-recorded, transcribed verbatim and analysed using Attride-Stirling's framework for thematic network analysis. RESULTS: The global theme 'The Future of PPS in EM-A UK and Ireland Perspective' emerged from the following three organising themes: (1) training and education of ED staff; (2) current realities of PPS in EDs and (3) PPS and the wider hospital community. The main findings were (1) there is variability in ED PPS practice throughout the UK and Ireland; (2) lack of formal PPS training for trainees is a barrier to its implementation as a standard treatment and (3) there is a lack of recognition of PPS at a College level as a specialised EM skill. CONCLUSIONS: Establishment of PPS as a standard treatment option in the emergency setting will require implementation of robust training into general and paediatric EM training. This should be supported and enhanced through national and international collaboration in EM-led PPS research and audit.
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Hipnóticos y Sedantes/administración & dosificación , Manejo del Dolor/métodos , Medicina de Urgencia Pediátrica , Pautas de la Práctica en Medicina/estadística & datos numéricos , Inglaterra , Femenino , Grupos Focales , Humanos , Capacitación en Servicio , Irlanda , Masculino , Investigación CualitativaRESUMEN
STUDY OBJECTIVE: In acute exacerbations of asthma in children, corticosteroids reduce relapses, subsequent hospital admission, and the need for ß2-agonist bronchodilators. Prednisolone is the most commonly used corticosteroid, but prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance. Dexamethasone has a longer half-life and has been used safely in other acute pediatric conditions. We examine whether a single dose of oral dexamethasone is noninferior to prednisolone in the emergency department (ED) treatment of asthma exacerbations in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM) at day 4. METHODS: We conducted a randomized, open-label, noninferiority trial comparing oral dexamethasone (single dose of 0.3 mg/kg) with prednisolone (1 mg/kg per day for 3 days) in patients aged 2 to 16 years and with a known diagnosis of asthma or at least 1 previous episode of ß2-agonist-responsive wheeze who presented to a tertiary pediatric ED. The primary outcome measure was the mean PRAM score (range of 0 to 12 points) performed on day 4. Secondary outcome measures included requirement for further steroids, vomiting of study medication, hospital admission, and unscheduled return visits to a health care practitioner within 14 days. RESULTS: There were 245 enrollments involving 226 patients. There was no difference in mean PRAM scores at day 4 between the dexamethasone and prednisolone groups (0.91 versus 0.91; absolute difference 0.005; 95% CI -0.35 to 0.34). Fourteen patients vomited at least 1 dose of prednisolone compared with no patients in the dexamethasone group. Sixteen children (13.1%) in the dexamethasone group received further systemic steroids within 14 days after trial enrollment compared with 5 (4.2%) in the prednisolone group (absolute difference 8.9%; 95% CI 1.9% to 16.0%). There was no significant difference between the groups in hospital admission rates or the number of unscheduled return visits to a health care practitioner. CONCLUSION: In children with acute exacerbations of asthma, a single dose of oral dexamethasone (0.3 mg/kg) is noninferior to a 3-day course of oral prednisolone (1 mg/kg per day) as measured by the mean PRAM score on day 4.
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Antiasmáticos/administración & dosificación , Antiinflamatorios/administración & dosificación , Asma/tratamiento farmacológico , Vías Clínicas , Dexametasona/administración & dosificación , Prednisolona/administración & dosificación , Enfermedad Aguda , Administración Oral , Adolescente , Asma/fisiopatología , Niño , Niño Hospitalizado , Preescolar , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Servicios Médicos de Urgencia , Femenino , Humanos , Masculino , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Pain is the most common symptom in the emergency setting and remains one of the most challenging problems for emergency care providers, particularly in the pediatric population. The primary objective of this study was to determine the prevalence of acute pain in children attending emergency departments (EDs) in Ireland by ambulance. In addition, this study sought to describe the prehospital and initial ED management of pain in this population, with specific reference to etiology of pain, frequency of pain assessment, pain severity, and pharmacological analgesic interventions. A prospective cross-sectional study was undertaken over a 12-month period of all pediatric patients transported by emergency ambulance to four tertiary referral hospitals in Ireland. All children (<16 years) who had pain as a symptom (regardless of cause) at any stage during the prehospital phase of care were included in this study. Over the study period, 6,371 children attended the four EDs by emergency ambulance, of which 2,635 (41.4%, 95% confidence interval 40.2-42.3%) had pain as a documented symptom on the ambulance patient care report (PCR) form. Overall 32% (n = 856) of children who complained of pain were subject to a formal pain assessment during the prehospital phase of care. Younger age, short transfer time to the ED, and emergency calls between midnight and 6 am were independently associated with decreased likelihood of having a documented assessment of pain intensity during the prehospital phase of care. Of the 2,635 children who had documented pain on the ambulance PCR, 26% (n = 689) received some form of analgesic agent prior to ED arrival. Upon ED arrival 54% (n = 1,422) of children had a documented pain assessment and some form of analgesic agent was administered to 50% (n = 1,324). Approximately 41% of children who attend EDs in Ireland by ambulance have pain documented as their primary symptom. This study suggests that the management of acute pain in children transferred by ambulance to the ED in Ireland is currently poor, with documentary evidence of only 26% receiving prehospital analgesic agents.
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Analgesia/métodos , Analgésicos/uso terapéutico , Servicio de Urgencia en Hospital , Manejo del Dolor/métodos , Dimensión del Dolor , Dolor/epidemiología , Adolescente , Ambulancias , Niño , Preescolar , Estudios Transversales , Femenino , Humanos , Lactante , Irlanda/epidemiología , Masculino , Prevalencia , Estudios Prospectivos , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: There is increasing evidence that propofol is efficacious and safe for procedural sedation (PS) in the emergency department (ED) setting. However, propofol has a narrow therapeutic window and lacks of a reversal agent. The aim of this review was to cohere the evidence base regarding the efficacy and safety profile of propofol when used in the ED setting for PS. OBJECTIVES: To identify and evaluate all randomized controlled trials (RCTs) comparing propofol with alternative drugs (benzodiazepines, barbiturates, etomidate and ketamine) used in the ED setting for PS. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE (1950 to September week 2 2013) and EMBASE (1980 to week 2 2013). We searched the Current Controlled Trials metaRegister of Clinical Trials (compiled by Current Science) (September 2013). We checked the reference lists of trials and contacted trial authors. We imposed no language restriction. We re-ran the search in February 2015. We will deal with the one study awaiting classification when we update the review. SELECTION CRITERIA: RCTs comparing propofol to alternative drugs (benzodiazepines, barbiturates, etomidate and ketamine) used in the ED setting for PS in participants of all ages. DATA COLLECTION AND ANALYSIS: Two authors independently performed data extraction. Two authors performed trial quality assessment. We used mean difference (MD), odds ratio (OR) and 95% confidence intervals (CI) to measure effect sizes. Two authors independently assessed and rated the methodological quality of each trial using The Cochrane Collaboration tool for assessing risk of bias. MAIN RESULTS: Ten studies (813 participants) met the inclusion criteria. Two studies only included participants 18 years and younger; six studies only included participants 18 years and older; one study included participants between 16 and 65 years of age and one study included only adults but did not specify the age range. Eight of the included studies had a high risk of bias. The included studies were clinically heterogeneous. We undertook no meta-analysis.The primary outcome measures of this review were: adverse effects (as defined by the study authors) and participant satisfaction (as defined by the study authors). In one study comparing propofol/fentanyl with ketamine/midazolam, delayed adverse reactions (nightmares and behavioural change) were noted in 10% of the ketamine/midazolam group and none in the propofol/fentanyl group. Seven individual studies reported no evidence of a difference in adverse effects between intravenous propofol, with and without adjunctive analgesic agents, and alternative interventions. Three individual studies reported no evidence of a difference in pain at the injection site between intravenous propofol and alternative interventions. Four individual studies reported no evidence of a difference in participant satisfaction between intravenous propofol, with and without adjunctive analgesic agents, and alternative interventions (ketamine, etomidate, midazolam). All the studies employed propofol without the use of an adjunctive analgesic and all, except one, were small (fewer than 100 participants) studies. The quality of evidence for the adverse effects and participant satisfaction outcomes was very low.Nine included studies (eight comparisons) reported all the secondary outcome measures of the review except mortality. It was not possible to pool the results of the included studies for any of the secondary outcome measures because the comparator interventions were different and the measures were reported in different ways. Seven individual studies reported no evidence of difference in incidence of hypoxia between intravenous propofol, with and without adjunctive analgesic agents, and alternative interventions. AUTHORS' CONCLUSIONS: No firm conclusions can be drawn concerning the comparative effects of administering intravenous propofol, with or without an adjunctive analgesic agent, with alternative interventions in participants undergoing PS in the ED setting on adverse effects (including pain at the injection site) and participant satisfaction. The review was limited because no two included studies employed the same comparator interventions, and because the number of participants in eight of the included studies were small (fewer than 100 participants).
Asunto(s)
Anestesia , Anestésicos Intravenosos , Servicio de Urgencia en Hospital , Propofol , Adolescente , Adulto , Anestésicos Intravenosos/administración & dosificación , Anestésicos Intravenosos/efectos adversos , Etomidato/administración & dosificación , Fentanilo/administración & dosificación , Humanos , Ketamina/administración & dosificación , Ketamina/efectos adversos , Midazolam/administración & dosificación , Persona de Mediana Edad , Propofol/administración & dosificación , Propofol/efectos adversos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Pain is the most common symptom in the emergency setting; however, timely management of acute pain in children continues to be suboptimal. Intranasal drug delivery has emerged as an alternative method of achieving quicker drug delivery without adding to the distress of a child by inserting an intravenous cannula. OBJECTIVES: We identified and evaluated all randomized controlled trials (RCTs) and quasi-randomized trials to assess the effects of intranasal fentanyl (INF) versus alternative analgesic interventions in children with acute pain, with respect to reduction in pain score, occurrence of adverse events, patient tolerability, use of "rescue analgesia," patient/parental satisfaction and patient mortality. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 1); MEDLINE (Ovid SP, from 1995 to January 2014); EMBASE (Ovid SP, from 1995 to January 2014); the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCO Host, from 1995 to January 2014); the Latin American and Caribbean Health Science Information Database (LILACS) (BIREME, from 1995 to January 2014); Commonwealth Agricultural Bureaux (CAB) Abstracts (from 1995 to January 2014); the Institute for Scientific Information (ISI) Web of Science (from 1995 to January 2014); BIOSIS Previews (from 1995 to January 2014); the China National Knowledge Infrastructure (CNKI) (from 1995 to January 2014); International Standard Randomized Controlled Trial Number (ISRCTN) (from 1995 to January 2014); ClinicalTrials.gov (from 1995 to January 2014); and the International Clinical Trials Registry Platform (ICTRP) (to January 2014). SELECTION CRITERIA: We included RCTs comparing INF versus any other pharmacological/non-pharmacological intervention for the treatment of children in acute pain (aged < 18 years). DATA COLLECTION AND ANALYSIS: Two independent review authors assessed each title and abstract for relevance. Full copies of all studies that met the inclusion criteria were retrieved for further assessment. Mean difference (MD), odds ratio (OR) and 95% confidence interval (CI) were used to measure effect sizes. Two review authors independently assessed and rated the methodological quality of each trial using the tool of The Cochrane Collaboration to assess risk of bias, as per Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: Three studies (313 participants) met the inclusion criteria. One study compared INF versus intramuscular morphine (IMM); another study compared INF versus intravenous morphine (IVM); and another study compared standard concentration INF (SINF) versus high concentration INF (HINF). All three studies reported a reduction in pain score following INF administration. INF produced a greater reduction in pain score at 10 minutes post administration when compared with IMM (INF group pain score: 1/5 vs IMM group pain score: 2/5; P value 0.014). No other statistically significant differences in pain scores were reported at any other time point. When INF was compared with IVM and HINF, no statistically significant differences in pain scores were noted between treatment arms, before analgesia or at 5, 10, 20 and 30 minutes post analgesia. Specifically, when INF was compared with IVM, both agents were seen to produce a statistically significant reduction in pain score up to 20 minutes post analgesia. No further reduction in pain score was noted after this time. When SINF was compared with HINF, a statistically and clinically significant reduction in pain scores over study time was observed (median decrease for both groups 40 mm, P value 0.000). No adverse events (e.g. opiate toxicity, death) were reported in any study following INF administration. One study described better patient tolerance to INF compared with IMM, which achieved statistical significance. The other studies described reports of a "bad taste" and vomiting with INF. Overall the risk of bias in all studies was considered low. AUTHORS' CONCLUSIONS: INF may be an effective analgesic for the treatment of patients with acute moderate to severe pain, and its administration appears to cause minimal distress to children. However, this review of published studies does not allow any definitive conclusions regarding whether INF is superior, non-inferior or equivalent to intramuscular or intravenous morphine. Limitations of this review include the following: few eligible studies for inclusion (three); no study examined the use of INF in children younger than three years of age; no study included children with pain from a "medical" cause (e.g. abdominal pain seen in appendicitis); and all eligible studies were conducted in Australia. Consequently, the findings may not be generalizable to other healthcare settings, to children younger than three years of age and to those with pain from a "medical" cause.
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Dolor Agudo/tratamiento farmacológico , Analgésicos Opioides/administración & dosificación , Fentanilo/administración & dosificación , Administración Intranasal , Niño , Humanos , Morfina/administración & dosificación , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION: Effective pain management in the prehospital setting is gaining momentum as a potential key performance indicator by many emergency medical service systems, but historically has been shown to be inadequate, particularly in the paediatric population. This study aimed to identify the barriers, as perceived by a national cohort of advanced paramedics (APs), to achieving optimal prehospital management of acute pain in children. METHODS: A qualitative approach was employed to capture data through two focus group interviews. Sixteen APs were invited to participate in this study. Both focus groups were audio recorded, transcribed and analysed using Attride-Stirling's framework for thematic network analysis. RESULTS: The global theme 'Understanding Barriers to the Prehospital Management of Acute Pain in Children' emerged from three organising themes as follows: AP education and training; current clinical practice guidelines for paediatric pain management; realities of prehospital practice. Limited exposure to children in the prehospital setting, difficulty assessing pain intensity in small children, and challenges in administering oral or inhaled analgesic agents to distressed and uncooperative children were highlighted by participants. Short transfer times to the emergency department, and a 'medical' cause of pain were also implicated as examples of when children are less likely to receive analgesia from practitioners. CONCLUSIONS: The pathway to improving care must include an emphasis on improvements in practitioner education and training, offering alternatives to assessing pain in preverbal children, exploring the intranasal route of drug delivery in managing acute severe pain, and robustly developed evidence-based guidelines that are practitioner friendly and patient-focused.
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Dolor Agudo/terapia , Servicios Médicos de Urgencia/normas , Manejo del Dolor/métodos , Pediatría/métodos , Dolor Agudo/diagnóstico , Adulto , Actitud del Personal de Salud , Niño , Preescolar , Estudios de Cohortes , Femenino , Grupos Focales , Accesibilidad a los Servicios de Salud , Humanos , Irlanda , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Investigación CualitativaRESUMEN
BACKGROUND: The use of procedural sedation outside the operating theatre has increased in hospital settings and has gained popularity among non-anesthesiologists. Sedative agents used for procedural pain, although effective, also pose significant risks to the patient if used incorrectly. There is currently no universally accepted program of education for practitioners using or introducing procedural sedation into their practice. There is emerging literature identifying structured procedural sedation programs (PSPs) as a method of ensuring a standardized level of competency among staff and reducing risks to the patient. We hypothesize that programs of education for healthcare professionals using procedural sedation outside the operating theatre are beneficial in improving patient care, safety, practitioner competence and reducing adverse event rates. METHODS/DESIGN: Electronic databases will be systematically searched for studies (randomized and non-randomized) examining the effectiveness of structured PSPs from 1966 to present. Database searches will be supplemented by contact with experts, reference and citation checking, and a grey literature search. No language restriction will be imposed. Screening of titles and abstracts, and data extraction will be performed by two independent reviewers. All disagreements will be resolved by discussion with an independent third party. Data analysis will be completed adhering to procedures outlined in the Cochrane Handbook of Systematic Reviews of Interventions. If the data allows, a meta-analysis will be performed. DISCUSSION: This review will cohere evidence on the effectiveness of structured PSPs on sedation events and patient outcomes within the hospital and other acute care settings. In addition, it will examine key components identified within a PSP associated with patient safety and improved patient outcomes. TRIAL REGISTRATION: PROSPERO registration number: CRD42013003851.
Asunto(s)
Sedación Consciente , Sedación Profunda , Educación Médica , Proyectos de Investigación , Seguridad , Revisiones Sistemáticas como Asunto , Competencia Clínica , Sedación Consciente/efectos adversos , Sedación Profunda/efectos adversos , Servicio de Urgencia en Hospital , Hospitales , Humanos , Dolor/prevención & control , Satisfacción del PacienteRESUMEN
INTRODUCTION: Acute non-traumatic limp is a common reason for children to present to the emergency department (ED). There is a wide differential diagnosis for these patients, and there are certain serious conditions which cannot be missed. An evidence based guideline for the 'limping child' was designed and the impact of guideline implementation on a number of specific, predefined quantitative outcomes was assessed. METHODS: An initial retrospective chart review over 3 months was carried out for all patients presenting with acute non-traumatic limp. Following guideline introduction and implementation, information was gathered prospectively for a further 3 month period. Data outcomes between the two patient groups were then compared. RESULTS: 110 patients met the criteria for inclusion: 56 pre-guideline and 54 post-guideline implementation. Baseline characteristics and diagnosis breakdown were similar in both groups. The rate of laboratory investigations was significantly reduced following guideline implementation (68% of patients pre-guideline, vs 48% post-guideline; (χ(2)), p=0.03). The number of x-rays carried out was similar in each group (74 pre- vs 67 post-guideline, mean 1.32 vs 1.28; (χ(2)), p=0.53). Length of time spent in the ED was significantly reduced following guideline implementation (median time 150 min pre- vs 82.5 min post-guideline; (χ(2)), p=0.04). No cases of serious pathology were missed using the guideline. CONCLUSION: Implementation of an evidence based clinical practice guideline for the limping child in a paediatric ED reduced the overall time patients spent in the ED, reduced the need for unnecessary laboratory investigations and ensured that appropriate investigations were carried out on an individual patient basis.
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Servicio de Urgencia en Hospital/estadística & datos numéricos , Marcha , Pruebas Hematológicas/estadística & datos numéricos , Tiempo de Internación/estadística & datos numéricos , Limitación de la Movilidad , Trastornos del Movimiento/diagnóstico , Guías de Práctica Clínica como Asunto , Adolescente , Niño , Preescolar , Medicina de Emergencia/métodos , Medicina de Emergencia Basada en la Evidencia , Femenino , Humanos , Lactante , Masculino , Estudios RetrospectivosRESUMEN
The Fliker, the new version of the foot-propelled scooter, has emerged as an increasingly popular recreational activity for children. This increase in popularity has led to a number of attendances to our tertiary paediatric emergency department (ED) with Fliker-associated injuries. The aim of this study was to examine the incidence and type of such injuries. This was a prospective descriptive study of all children (aged 0-16 years) attending the ED during a summer with Fliker-related injuries. Patients were identified through the ED Symphony Information System. Clinical notes of identified patients were investigated for the mechanism, location and type of injury. The clinical outcome of identified patients was also determined. Eighty patients, 39 boys (48.8%) and 41 girls (51.2%), were identified in the study period. The mean age of the patients was 7.9 years (range from 2 to 13 years). Upper limb injuries were most common, found in 33 (41.2%) children. There were 12 head injuries. The rest sustained lower limb injuries, soft tissue lacerations and dental injuries. The Fliker is one of a number of fad recreational activities to have emerged in recent times. Similar to some of its predecessors (e.g. Heelys, rollerblades), it is associated with a spectrum of injuries in children.
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Juego e Implementos de Juego/lesiones , Adolescente , Niño , Preescolar , Traumatismos Craneocerebrales/epidemiología , Traumatismos Faciales/epidemiología , Femenino , Humanos , Incidencia , Lactante , Laceraciones/epidemiología , Masculino , Estudios Prospectivos , Traumatismos de los Tejidos Blandos/epidemiologíaRESUMEN
BACKGROUND: Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß2-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to examine whether a single dose of oral dexamethasone (0.3 mg/kg) is clinically non-inferior to prednisolone (1 mg/kg/day for three days) in the treatment of exacerbations of asthma in children who attend the Emergency Department. METHODS/DESIGN: This is a randomized, non-inferiority, open-label clinical trial. After informed consent with or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison between the Pediatric Respiratory Assessment Measure (PRAM) across both groups on Day 4. The PRAM score, a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, will be performed by a clinician blinded to treatment allocation. Secondary outcomes include relapse, hospital admission and requirement for further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to follow-up), we will be able to reject the null hypothesis - that the population means of the experimental and control groups are equal with a probability (power) of 0.9. The Type I error probability associated with this test (of the null hypothesis) is 0.05. DISCUSSION: This clinical trial may provide evidence that a shorter steroid course using dexamethasone can be used in the treatment of acute pediatric asthma, thus eliminating the issue of compliance to treatment. REGISTRATION: ISRCTN26944158 and EudraCT Number 2010-022001-18.
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Antiasmáticos/administración & dosificación , Antiinflamatorios/administración & dosificación , Asma/tratamiento farmacológico , Dexametasona/administración & dosificación , Servicios Médicos de Urgencia/métodos , Prednisolona/administración & dosificación , Enfermedad Aguda , Administración Oral , Adolescente , Antiasmáticos/efectos adversos , Antiinflamatorios/efectos adversos , Niño , Preescolar , Dexametasona/efectos adversos , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Prednisolona/efectos adversos , Proyectos de InvestigaciónRESUMEN
BACKGROUND: Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain. METHODS/DESIGN: This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05. DISCUSSION: This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67469672 and EudraCT no. 2011-005161-20.
Asunto(s)
Analgésicos Opioides/administración & dosificación , Anemia de Células Falciformes/tratamiento farmacológico , Servicio de Urgencia en Hospital , Fentanilo/administración & dosificación , Morfina/administración & dosificación , Dolor/tratamiento farmacológico , Proyectos de Investigación , Administración Intranasal , Adolescente , Aerosoles , Analgésicos Opioides/efectos adversos , Anemia de Células Falciformes/complicaciones , Anemia de Células Falciformes/diagnóstico , Niño , Preescolar , Método Doble Ciego , Fentanilo/efectos adversos , Humanos , Lactante , Inyecciones Intravenosas , Irlanda , Morfina/efectos adversos , Nebulizadores y Vaporizadores , Dolor/diagnóstico , Dolor/etiología , Dimensión del Dolor , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
AIM: We sought to review the clinical outcomes of patients referred to our emergency department (ED) vaccination service for children with a history of allergy or anaphylaxis or in whom there was a concern of a significant adverse reaction. METHODS: This was a prospective observational cohort study set in an urban tertiary Paediatric ED. All attendances for any childhood vaccination for a 5-year period (from January 1, 2006 to December 31, 2010) were included. Our primary outcome measure was any adverse reaction as a result of the vaccine administered. RESULTS: A total of 446 vaccines were administered during the study period in 374 patients. Of these vaccinations, 310 (69.5%) were Measles, Mumps, Rubella (MMR). The majority of patients (348, 93%) were referred from the community. Suspected egg allergy was the reason for the majority of referrals for MMR (261/310 (84.2%)). Only six patients (1.3%) experienced an immediate reaction to a vaccination. All reactions were minor. CONCLUSION: This is one of the largest studies looking at childhood vaccinations performed in a hospital setting for children who are 'at risk' of allergy, anaphylaxis or hypersensitivity. A significant number of referrals were unwarranted and the majority could have been safely managed in the community.