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1.
Pediatr Emerg Care ; 38(8): 372-375, 2022 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-35904951

RESUMO

OBJECTIVES: Data from the 2019 National Survey of Children's Health revealed that 39.8% of children in the United States have been exposed to adverse childhood experiences (ACEs), which are risk factors for long-term negative health outcomes. This study aimed to determine the prevalence of ACE exposure in a pediatric emergency department (ED) patients and describe the association between ACE exposure and ED recidivism. METHODS: Five hundred children aged 0 to 17 years were evaluated for ACE exposure in an academic, urban, tertiary-care, pediatric ED via convenience sampling. The 2019 National Survey of Children's Health section on ACEs was administered to define ACE exposure. A prospective chart review was conducted on all children enrolled in the study to collect data on ED utilization for 1-year postsurvey. The relationship between ACE exposure and ED recidivism was examined by calculating relative risk. RESULTS: We found that 40.2% (confidence interval [CI], 36.5%-45.3%) of respondents had ACE exposure. The most frequently reported ACEs were poverty (20.8%; CI, 17.3%-24.6%), divorce/separation (18.2%; CI, 14.9%-21.9%), and mental illness within the household (7.2%; CI, 5.1%-9.8%). Adverse childhood experience exposure in this pediatric ED was similar to the national prevalence. There was no significant relationship between ACE exposure and high ED recidivism as an adverse outcome. CONCLUSIONS: Adverse childhood experience exposure in this population matched the prevalence reported in the national population. Our results suggest that this group is particularly important when mitigating these risk factors for long-term adverse health outcomes. Adverse childhood experience exposure did not appear to impact recidivism in a period of unprecedented low ED volumes during the coronavirus disease pandemic.


Assuntos
Experiências Adversas da Infância , Serviços Médicos de Emergência , Criança , Serviço Hospitalar de Emergência , Humanos , Prevalência , Estudos Prospectivos , Estados Unidos
2.
Pediatr Emerg Care ; 37(12): e950-e954, 2021 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31335787

RESUMO

OBJECTIVE: This study aimed to assess the agreement between patients presenting to the pediatric emergency department (ED) with acute pain and their caregivers when using the Wong-Baker FACES (WBF) and Faces Pain Scale-Revised (FPS-R). METHODS: This was a prospective, observational study examining patients 3 to 7.5 years old presenting to a pediatric ED with acute pain. Participants completed the WBF and FPS-R twice during their ED evaluation. Caregivers rated their child's pain using both the WBF and FPS-R at the same time points. Intraclass correlations (ICCs) were calculated between caregiver and child reports at each time point, and Bland-Altman plots were created. RESULTS: Forty-six subjects were enrolled over 5 months. Mean age was 5.5 ± 1.2 years. Average initial child pain scores were 6.6 ± 2.8 (WBF) and 6.1 ± 3.3 (FPS-R), and repeat scores were 3.3 ± 3.4 (WBF) and 3.1 ± 3.3 (FPS-R). Average initial caregiver pain scores were 6.3 ± 2.4 (WBF) and 6.2 ± 2.3 (FPS-R), and repeat scores were 3.4 ± 2.0 (WBF) and 3.4 ± 2.1 (FPS-R). On initial assessment, ICCs between children and caregivers using the FPS-R and WBF were 0.33 and 0.22, respectively. On repeat assessment, the ICCs were 0.31 for FPS-R and 0.26 for WBF. Bland-Altman plots showed poor agreement but no systematic bias. CONCLUSION: There was poor agreement between caregivers and children when using the WBF and FPS-R for assessment of acute pain in the ED. Caregiver report should not be used as a substitute for self-report of pain if possible.


Assuntos
Cuidadores , Dor , Criança , Pré-Escolar , Serviço Hospitalar de Emergência , Humanos , Dor/diagnóstico , Dor/etiologia , Medição da Dor , Estudos Prospectivos
3.
J Trauma Nurs ; 28(4): 235-242, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34210943

RESUMO

BACKGROUND: Children who experience traumatic physical injuries are at risk of developing acute stress disorder and posttraumatic stress disorder (PTSD). Early identification and treatment of these high-risk children can lead to improved mental health outcomes in this population. OBJECTIVE: This study assesses the feasibility of a study protocol that compares 3 screening tools for identifying patients at a high risk of later development of acute stress disorder or PTSD among pediatric trauma patients. METHODS: This pilot study compared 3 questionnaires used as screening tools for predictors of later development of PTSD in a convenience sample of pediatric trauma patients aged 7-17 years. Patients were randomized to one of 3 screening tools. Families were contacted at 30, 60, and 90-120 days postinjury to complete the Child Report of Post-Traumatic Symptoms questionnaire. The sensitivity and negative predictive value of the screening tools were compared for the diagnosis of PTSD defined using the Child Report of Post-Traumatic Symptoms questionnaire. RESULTS: Of the 263 patients identified for possible enrollment, 52 patients met full inclusion criteria and agreed to participate. Only 29 (55.7%) patients completed at least one follow-up questionnaire. The prevalence of acute stress disorder and PTSD in our population was 41% (95% CI [24, 61]) and 31% (95% CI [15, 51]), respectively. CONCLUSIONS: In this pilot study, we sought to determine the utility of the 3 commonly used screening instruments for measuring traumatic stress symptoms in pediatric trauma patients to predict the diagnosis of acute stress disorder or PTSD. Limitations include the use of the Child Report of Post-Traumatic Symptoms screening tool as the gold standard for calculating test characteristics and lack of 24/7 enrollment capabilities. As such, a significant portion of patients were discharged prior to our teams' engagement for enrollment.


Assuntos
Transtornos de Estresse Pós-Traumáticos , Transtornos de Estresse Traumático Agudo , Adolescente , Criança , Humanos , Programas de Rastreamento , Projetos Piloto , Valor Preditivo dos Testes
4.
Prehosp Emerg Care ; 20(6): 759-767, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27411064

RESUMO

BACKGROUND: The National Association of Emergency Medical Services Physicians' (NAEMSP) Position Statement on Prehospital Pain Management and the joint National Highway Traffic Safety Administration (NHTSA) and Emergency Medical Services for Children (EMSC) Evidence-based Guideline for Prehospital Analgesia in Trauma aim to improve the recognition, assessment, and treatment of prehospital pain. The impact of implementation of these guidelines on pain management in children by emergency medical services (EMS) agencies has not been assessed. OBJECTIVE: Determine the change in frequency of documented pain severity assessment and opiate administration among injured pediatric patients in three EMS agencies after adoption of best practice recommendations. METHODS: This is a retrospective study of children <18 years of age with a prehospital injury-related primary impression from three EMS agencies. Each agency independently implemented pain protocol changes which included adding the use of age-appropriate pain scales, decreasing the minimum age for opiate administration, and updating fentanyl dosing. We abstracted data from prehospital electronic patient records before and after changes to the pain management protocols. The primary outcomes were the frequency of administration of opioid analgesia and documentation of pain severity assessment as recorded in the prehospital patient care record. RESULTS: A total of 3,597 injured children were transported prior to pain protocol changes and 3,743 children after changes. Opiate administration to eligible patients across study sites regardless of documentation of pain severity was 156/3,089 (5%) before protocol changes and 175/3,509 (5%) after (p = 0.97). Prior to protocol changes, 580 (18%) children had documented pain assessments and 430 (74%) had moderate-to-severe pain. After protocol changes, 644 (18%) patients had pain severity documented with 464 (72%) in moderate-to-severe pain. For all study agencies, pain severity was documented in 13%, 19%, and 22% of patient records both before and after protocol changes. There was a difference in intranasal fentanyl administration rates before (27%) and after (17%) protocol changes (p = 0.02). CONCLUSION: The proportion of injured children who receive prehospital opioid analgesia remains suboptimal despite implementation of best practice recommendations. Frequency of pain severity assessment of injured children is low. Intranasal fentanyl administration may be an underutilized modality of prehospital opiate administration.


Assuntos
Analgésicos Opioides/uso terapêutico , Serviços Médicos de Emergência/métodos , Manejo da Dor/métodos , Dor/tratamento farmacológico , Adolescente , Criança , Documentação/estatística & dados numéricos , Feminino , Humanos , Masculino , Medição da Dor , Estudos Retrospectivos
5.
Prehosp Emerg Care ; 20(3): 311-6, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26808233

RESUMO

BACKGROUND: Pediatric prehospital research has been limited, but work in this area is starting to increase particularly with the growth of pediatric-specific research endeavors. Given the increased interest in pediatric prehospital research, there is a need to identify specific research priorities that incorporate the perspective of prehospital providers and other emergency medical services (EMS) stakeholders. OBJECTIVES: To develop a list of specific research priorities that is relevant, specific, and important to the practice of pediatric prehospital care. METHODS: Three independent committees of EMS providers and researchers were recruited. Each committee developed a list of research topics. These topics were collated and used to initiate a modified Delphi process for developing consensus on a list of research priorities. Participants were the committee members. Topics approved by 80% were retained as research priorities. Topics that were rejected by more than 50% were eliminated. The remaining topics were modified and included on subsequent surveys. Each survey allowed respondents to add additional topics. The surveys were continued until all topics were either successfully retained or rejected and no new topics were suggested. RESULTS: Fifty topics were identified by the three independent committees. These topics were included on the initial electronic survey. There were 5 subsequent surveys. At the completion of the final survey a total of 29 research priorities were identified. These research priorities covered the following study areas: airway management, asthma, cardiac arrest, pain, patient-family interaction, resource utilization, seizure, sepsis, spinal immobilization, toxicology, trauma, training and competency, and vascular access. The research priorities were very specific. For example, under airway the priorities were: "identify the optimal device for effectively managing the airway in the prehospital setting" and "identify the optimal airway management device for specific disease processes." CONCLUSION: This project developed a list of relevant, specific, and important research priorities for pediatric prehospital care. Some similarities exist between this project and prior research agendas but this list represents a current, more specific research agenda and reflects the opinions of working EMS providers, researchers, and leaders. KEY WORDS: emergency medical technician; research; emergency medical services; priorities.


Assuntos
Comitês Consultivos , Serviços Médicos de Emergência , Pesquisa sobre Serviços de Saúde , Pediatria , Técnica Delphi , Humanos
6.
Pediatr Emerg Care ; 32(9): 645-7, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27585128

RESUMO

OBJECTIVE: The aim of this article was to discuss the current landscape in pediatric emergency medicine fellowship training for scholarship training and provide an overview of the resources and general strategies required to prepare fellows for their careers. OVERVIEW: This article is the fifth in a 7-part series that aims to comprehensively describe the current state and future directions of pediatric emergency medicine fellowship training from the essential requirements to considerations for successfully administering and managing a program to the careers that may be anticipated upon program completion. This article focuses on scholarship training.


Assuntos
Educação de Pós-Graduação em Medicina , Medicina de Emergência/educação , Bolsas de Estudo , Pediatria/educação , Currículo , Humanos , Especialização
7.
Pediatr Emerg Care ; 32(5): 337-9, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27139296

RESUMO

This article is the first in a 7-part series (Table 1) that aims to comprehensively describe the current state and future directions of pediatric emergency medicine fellowship training from the essential requirements to considerations for successfully administering and managing a program to the careers that may be anticipated on program completion. This overview article provides a framework for the series.


Assuntos
Educação de Pós-Graduação em Medicina , Medicina de Emergência/educação , Bolsas de Estudo , Pediatria/educação , Currículo , Avaliação Educacional , Humanos , Estados Unidos
8.
Pediatr Emerg Care ; 32(6): 410-8, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27253361

RESUMO

This article is the second in a 7-part series that aims to comprehensively describe the current state and future directions of pediatric emergency medicine (PEM) fellowship training from the essential requirements to considerations for successfully administering and managing a program to the careers that may be anticipated upon program completion. This article describes the development of PEM entrustable professional activities (EPAs) and the relationship of these EPAs with existing taxonomies of assessment and learning within PEM fellowship. It summarizes the field in concepts that can be taught and assessed, packaging the PEM subspecialty into EPAs.


Assuntos
Educação de Pós-Graduação em Medicina , Medicina de Emergência/educação , Bolsas de Estudo , Pediatria/educação , Prática Profissional , Humanos , Estados Unidos
9.
West J Emerg Med ; 21(3): 549-554, 2020 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-32421500

RESUMO

Human trafficking is a human rights violation affecting millions worldwide. Victims may go unrecognized during their emergency department (ED) visit, and may lose the opportunity to address their complex needs. Using a published toolkit based on existing guidelines and recommendations from experts, and models from other centers, we describe the implementation of an ED response protocol. In following the recommendations of the toolkit, we began with attempts to fully understand the local human trafficking problem and then networked with those working in anti-trafficking efforts. Collaboration with other specialties is highlighted as a key part of this process. Building upon the knowledge gained from these steps, we were able to develop a concise protocol to guide members of our department in more effectively caring for known or suspected victims of human trafficking. The first section of the protocol addresses ways in which providers can identify at-risk patients through both screening questions and general observations. Interviewing techniques are outlined with an emphasis on patient-centered and trauma-informed care. Additionally, the protocol discusses physician responsibility in documenting encounters and legal reporting, which may vary depending on location. We stress the importance of meeting the needs of the patient while prioritizing the safety of all involved. Additionally, the protocol provides a list of resources for the patient beyond medical care such as emergency housing, legal assistance, and food pantries. The overall purpose of this protocol is to provide coordinated response so that all providers may be consistent in caring for this vulnerable population.


Assuntos
Procedimentos Clínicos , Serviço Hospitalar de Emergência , Pessoal de Saúde , Tráfico de Pessoas/prevenção & controle , Procedimentos Clínicos/legislação & jurisprudência , Procedimentos Clínicos/normas , Tráfico de Pessoas/ética , Tráfico de Pessoas/psicologia , Humanos , Colaboração Intersetorial , Papel Profissional , Melhoria de Qualidade , Populações Vulneráveis
10.
Implement Sci Commun ; 1: 22, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32885182

RESUMO

BACKGROUND: Asthma is a difficult-to-manage chronic disease marked with associated outcome disparities including an increase rate of emergency department (ED) visits for uncontrolled asthma among patients who are most at-risk. Shared decision making (SDM) is a process by which the patient and provider jointly make a healthcare choice. SDM improves patient outcomes; however, implementation barriers of time constraints and staff availability are limitations. The use of health IT solutions may increase the adoption of SDM, but best practices for implementation are not well understood. The Consolidated Framework for Implementation Research (CFIR) is a flexible comprehensive model used to identify barriers and facilitators influencing implementation. The goal of this study is to implement an innovative web-based pediatric SDM tool in the real-world setting of two large healthcare system EDs through the following aims: (1) convene a patient, research, and ED stakeholder advisory board to oversee review of protocol and study materials prior to implementation, (2) implement the SDM intervention where providers and staff will be trained to incorporate use of this SDM intervention, (3) conduct on-going evaluation of barriers, facilitators, and implementation outcomes to tailor implementation in the EDs, (4) evaluate patient-centered outcomes of primary care utilization and changes in ED visits and hospitalizations before and after the SDM intervention, and (5) understand and document best practices for ED implementation. METHODS: The CFIR model will guide the implementation evaluation. Researchers will administer surveys to the clinical team and patients at baseline, 3, 6, and 12 months to inform implementation design, determine barriers and facilitators, and resource-needs to allow for real-time process adjustments within the EDs. Focus group or key-informant interviews and analysis will provide additional feedback to the stakeholder team to iterate the implementation process. Researchers will track patient-centered outcomes including increased primary care, ED, and inpatient utilization over the duration of the study. DISCUSSION: To advance asthma care and the field of implementation science, further research is needed to assess best practices for incorporating SDM into high-need healthcare settings such as the ED. This knowledge will facilitate improved outcomes and appropriate policy changes towards further use of SDM interventions in local and national acute care settings.

11.
Acad Emerg Med ; 26(5): 510-516, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30343530

RESUMO

BACKGROUND: Although all emergency departments (EDs) should be ready to treat children, some may have illnesses or injuries that require higher-level pediatric resources that are not available at all hospitals. There are no national guidelines for emergency medical services (EMS) providers about when to directly transport children to hospitals with higher-level pediatric resources, with the exception of severe trauma. Variability exists in EMS protocols about when children warrant transport to hospitals with higher-level pediatric care. OBJECTIVE: The objective was to determine how frequently pediatric patients are transported by EMS to hospitals with higher-level pediatric resources and to evaluate distribution patterns based on illness and injury severity. METHODS: We conducted a retrospective analysis of all pediatric (age 0-18 years) transports in three large EMS systems between November 2014 and November 2016. Each community had a hospital with higher-level pediatric resources that was within a 30-minute transport time from any location. Patients were included if they were transported by ground ambulance and the request originated in the 9-1-1 system. We assessed the frequency of transports to a hospital with higher-level pediatric resources. Data were stratified by chief complaint of illness or injury and severity. Potential risk for severe injury was defined as meeting the physiologic step of the field triage guidelines and potential risk for severe illness was defined as having an abnormal vital sign after adjusting for patient age. RESULTS: A total of 41,345 pediatric patients were transported by a participating EMS agency to an ED and had complete destination data. A total of 55% of all EMS-transported pediatric patients were transported to a hospital with higher-level pediatric resources. There was variation by site (range = 45%-71%) in the percentage of children who went to a hospital with higher-level pediatric resources. Patients over 15 years of age went to general EDs (57%) more often than younger patients. When stratified by severity, 60% of those with potentially severe illness and 74% of those with potentially severe trauma were transported to a hospital with higher-level pediatric resources. CONCLUSIONS: EMS providers commonly transport children to hospitals with higher-level pediatric resources. However, more than one-quarter of children with potentially severe injuries and illnesses are transported to general EDs.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Transporte de Pacientes/estatística & dados numéricos , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Escala de Gravidade do Ferimento , Masculino , Avaliação das Necessidades , Estudos Retrospectivos , Índice de Gravidade de Doença , Triagem/normas
12.
Emerg Med Clin North Am ; 36(2): 473-483, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29622335

RESUMO

Thoracic injuries account for less than one-tenth of all pediatric trauma-related injuries but comprise 14% of pediatric trauma-related deaths. Thoracic trauma includes injuries to the lungs, heart, aorta and great vessels, esophagus, tracheobronchial tree, and structures of the chest wall. Children have unique anatomic features that change the patterns of observed injury compared with adults. This review article outlines the clinical presentation, diagnostic testing, and management principles required to successfully manage injured children with thoracic trauma.


Assuntos
Medicina de Emergência Pediátrica/métodos , Traumatismos Torácicos , Criança , Maus-Tratos Infantis/diagnóstico , Humanos , Radiografia Torácica/métodos , Traumatismos Torácicos/diagnóstico , Traumatismos Torácicos/terapia
13.
Acad Emerg Med ; 24(12): 1430-1440, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28926159

RESUMO

OBJECTIVES: We compared the tolerability and efficacy of intranasal subdissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger noninferiority trial that could investigate the potential opioid-sparing effects of intranasal ketamine. METHODS: This randomized controlled trial compared 1 mg/kg intranasal ketamine to 1.5 µg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures presenting to an urban Level II pediatric trauma center from December 2015 to November 2016. Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the emergency department (ED) stay, and the feasibility of enrolling children presenting to the ED in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room. RESULTS: Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6-11) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73 ± 26) and fentanyl (69 ± 26; mean difference [95% CI] = 4 [-7 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most common side effects of ketamine were bad taste in the mouth (37; 90.2%), dizziness (30; 73.2%), and sleepiness (19; 46.3%). The most common side effects of fentanyl were sleepiness (15; 36.6%), bad taste in the mouth (9; 22%), and itchy nose (9; 22%). No patients experienced respiratory side effects. At 20 minutes, the mean pain scale score reduction was 44 ± 36 for ketamine and 35 ± 29 for fentanyl (mean difference = 9 [95% CI = -4 to 23]). Procedural sedation with ketamine occurred in 28 ketamine patients (65%) and 25 fentanyl patients (57%) prior to completing the study. CONCLUSIONS: Intranasal ketamine was associated with more minor side effects than intranasal fentanyl. Pain relief at 20 minutes was similar between groups. Our data support the feasibility of a larger, noninferiority trial to more rigorously evaluate the safety, efficacy, and potential opioid-sparing benefits of intranasal ketamine analgesia for children with acute pain.


Assuntos
Dor Aguda/tratamento farmacológico , Analgésicos/uso terapêutico , Fentanila/uso terapêutico , Fraturas Ósseas/complicações , Ketamina/uso terapêutico , Dor Aguda/diagnóstico , Dor Aguda/etiologia , Administração Intranasal , Adolescente , Traumatismos do Braço/complicações , Criança , Pré-Escolar , Método Duplo-Cego , Serviço Hospitalar de Emergência , Feminino , Humanos , Traumatismos da Perna/complicações , Masculino , Avaliação de Resultados em Cuidados de Saúde , Medição da Dor
14.
BMJ Open ; 7(7): e017190, 2017 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-28698351

RESUMO

INTRODUCTION: Pediatric sickle cell disease, highly prevalent in sub-Saharan Africa, carries great morbidity and mortality risk. Limited resources and monitoring make management of acute vaso-occlusive crises challenging. This study aims to evaluate the efficacy and safety of subdissociative intranasal ketamine as a cheap, readily available and easily administered adjunct to standard pain therapy. We hypothesise that subdissociative, intranasal ketamine may significantly augment current approaches to pain management in resource-limited settings in a safe and cost-effective manner. METHODS AND ANALYSIS: This is a multicentred, randomised, double-blind, placebo-controlled trial enrolling children 4-16 years of age with sickle cell disease and painful vaso-occlusive pain crises. Study sites include two sub-Saharan teaching and referral hospitals with acute intake areas. All patients receive standard analgesic therapy during evaluation. Patients randomised to the treatment arm receive 1 mg/kg intranasal ketamine at onset of therapy, while placebo arm participants receive volume-matched intranasal normal saline. All participants and clinical staff are blinded to the treatment allocation. Data will be analysed on an intention-to-treat basis. Primary endpoints are changes in self-report pain scales (Faces Pain Scale-Revised) at 30, 60 and 120 minutes and rates of adverse events. Secondary endpoints include hospital length of stay, total analgesia use and quality of life assessment 2-3 weeks postintervention. ETHICS AND DISSEMINATION: The research methods for this study have been approved by the Cameroon Baptist Convention Health Board Institutional Review Board (IRB2015-07), the Tanzanian National Institute for Medical Research (NIMR/HQ/R.8a/Vol. IX/2299), Muhimbili National Hospital IRB (MNH/IRB/I/2015/14) and the Tanzanian Food and Drugs Authority (TFDA0015/CTR/0015/9). Data reports will be provided to the Data and Safety Monitoring Board (DSMB) periodically throughout the study as well as all reports of adverse events. All protocol amendments will also be reviewed by the DSMB. Study results, regardless of direction or amplitude, will be submitted for publication in relevant peer-reviewed journals. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT02573714. Date of registration: 8 October 2015. Pre-results.


Assuntos
Analgésicos/administração & dosagem , Anemia Falciforme/complicações , Ketamina/administração & dosagem , Dor/tratamento farmacológico , Doenças Vasculares/fisiopatologia , Administração Intranasal , Adolescente , Camarões , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Masculino , Manejo da Dor , Medição da Dor , Qualidade de Vida , Projetos de Pesquisa , Tanzânia
15.
BMJ Open ; 6(9): e012190, 2016 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-27609854

RESUMO

INTRODUCTION: Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. METHODS AND ANALYSIS: This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 µg/kg) for analgesia in 80 children aged 4-17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. ETHICS AND DISSEMINATION: This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. TRIAL REGISTRATION NUMBER: NCT02521415.


Assuntos
Serviço Hospitalar de Emergência , Fentanila/uso terapêutico , Fraturas Ósseas/complicações , Ketamina/uso terapêutico , Dor/tratamento farmacológico , Projetos de Pesquisa , Administração Intranasal , Adolescente , Analgesia/métodos , Analgésicos , Analgésicos Opioides/uso terapêutico , Criança , Pré-Escolar , Método Duplo-Cego , Extremidades/lesões , Feminino , Fentanila/administração & dosagem , Humanos , Ketamina/administração & dosagem , Masculino , Dor/etiologia , Pediatria/métodos , Projetos Piloto , Resultado do Tratamento
16.
J Pediatr Hematol Oncol ; 30(2): 135-41, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18376266

RESUMO

BACKGROUND: We evaluated the prevalence of hemostatic disorders among pediatric patients with abnormal screening coagulation tests. PROCEDURE: We analyzed 48 consecutive referrals for abnormal prothrombin times, partial thromboplastin times, or closure times obtained as preprocedural screens. Patients were evaluated by uniform diagnostic testing. RESULTS: Seventeen patients (35%) had an isolated nonspecific inhibitor (NSI). Six patients (12.5%) presented with mildly low factor activity with a concomitant NSI. These deficiencies were of unclear clinical significance. One patient (2%) had a lupus anticoagulant. Only 9 patients (19%) had a possible or true mild bleeding disorder: 5 patients (10%) had isolated low von Willebrand factor levels, 2 patients (4%) had possible type I von Willebrand disease, and 2 (4%) had platelet aggregation disorders. In all patients, personal and family bleeding history had a positive predictive value of 45% for hemostatic disorders. CONCLUSIONS: The most common diagnosis among the patients referred to us for abnormal preoperative coagulation tests was a NSI, which is not associated with an increased risk of operative bleeding complications. Less than 20% had a possible or true mild bleeding disorder. Although certain bleeding disorders can be occult in children and are associated with perioperative bleeding risks, our study demonstrates the inherent limitations in making a laboratory diagnosis of a bleeding disorder in pediatric patients preoperatively. Our findings contribute to existing doubt about the usefulness of prothrombin times, partial thromboplastin times, and closure times to identify occult bleeding disorders in this population.


Assuntos
Transtornos da Coagulação Sanguínea/epidemiologia , Adolescente , Adulto , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Otolaringologia , Tempo de Tromboplastina Parcial , Prevalência , Tempo de Protrombina , Encaminhamento e Consulta , Doenças de von Willebrand/diagnóstico
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