RESUMEN
OBJECTIVES: Leftover opioids can contribute to misuse and abuse. Recommended dosing quantities in the electronic medical record can guide prescribing patterns. We hypothesized that decreasing the default from 30 doses to 12 doses would decrease the overall number of opioids prescribed without increasing second opioid prescriptions or additional health utilization. METHODS: We performed a single-center retrospective study of children with forearm and elbow fractures who presented to the emergency department for evaluation and subsequent orthopedic follow-up between January 15, and September 19, 2017. The default dispensing quantity was decreased on June 1, 2016 from 30 doses to 12 doses. Patients were categorized to preintervention and postintervention groups. We compared the number of opioids prescribed, second opioid prescriptions, emergency department visits, and pain-related telephone calls and orthopedic visits with χ2 and logistic regression analyses. RESULTS: There were 1107 patients included. Rates of opioid prescribing were similar preintervention and postintervention (61% vs 56%, P = 0.13). After the change to the default quantity, the median number of doses decreased from 18 to 12 doses, with opioid prescriptions of 30 or more doses dropping from 35% to 11%. No significant association was found between preintervention versus postintervention, opioid prescription at discharge, and having 1 or more pain-related or unexpected follow-up visits. CONCLUSIONS: Lowering the default dispensing quantity of opioids in the electronic medical record decreases the number of opioids prescribed without increasing second prescriptions or additional health care utilization. These findings suggest that a further reduction in the number of opioids prescribed for upper-extremity fractures may be possible.
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Analgésicos Opioides , Registros Electrónicos de Salud , Analgésicos Opioides/uso terapéutico , Niño , Prescripciones de Medicamentos , Humanos , Pautas de la Práctica en Medicina , Estudios RetrospectivosRESUMEN
ABSTRACT: Many gaps remain in finding effective, safe, and equitable treatments for children and adolescents with chronic pain and in accessing treatments in different settings. A major goal of the field is to improve assessment of pain and related experience. Valid and reliable patient-reported outcome measures are critical for advancing knowledge of clinical interventions for pediatric chronic pain. Building on the work of the Ped-IMMPACT group, we previously updated a core outcome set (COS) for pediatric chronic pain clinical trials using stakeholder feedback from providers, youth, and parents. The new COS includes 3 mandatory domains: pain severity, pain-related interference with daily living, and adverse events and 4 optional domains: overall well-being, emotional functioning, physical functioning, and sleep quality. The aim of this study was to use a multiphased approach to recommend specific measures for each of the 7 domains identified in our new COS for pediatric chronic pain. We synthesized evidence through conducting the following: (1) a Delphi study of experts to identify candidate measures for the new COS domains, (2) a review phase to gather evidence for measurement properties for candidate measures, and (3) an expert consensus conference to reach agreement on measurement recommendations. Final recommendations included 9 patient-reported measures. Important contextual considerations are discussed, and guidance is provided regarding strengths and limitations of the recommendations. Implementation of these recommendations may be enhanced by widespread dissemination and ease of access to measurement tools.
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Dolor Crónico , Ensayos Clínicos como Asunto , Adolescente , Niño , Humanos , Dolor Crónico/diagnóstico , Dolor Crónico/terapia , Consenso , Técnica Delphi , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Resultado del TratamientoRESUMEN
Large variability in the individual response to even the most-efficacious pain treatments is observed clinically, which has led to calls for a more personalized, tailored approach to treating patients with pain (ie, "precision pain medicine"). Precision pain medicine, currently an aspirational goal, would consist of empirically based algorithms that determine the optimal treatments, or treatment combinations, for specific patients (ie, targeting the right treatment, in the right dose, to the right patient, at the right time). Answering this question of "what works for whom" will certainly improve the clinical care of patients with pain. It may also support the success of novel drug development in pain, making it easier to identify novel treatments that work for certain patients and more accurately identify the magnitude of the treatment effect for those subgroups. Significant preliminary work has been done in this area, and analgesic trials are beginning to utilize precision pain medicine approaches such as stratified allocation on the basis of prespecified patient phenotypes using assessment methodologies such as quantitative sensory testing. Current major challenges within the field include: 1) identifying optimal measurement approaches to assessing patient characteristics that are most robustly and consistently predictive of inter-patient variation in specific analgesic treatment outcomes, 2) designing clinical trials that can identify treatment-by-phenotype interactions, and 3) selecting the most promising therapeutics to be tested in this way. This review surveys the current state of precision pain medicine, with a focus on drug treatments (which have been most-studied in a precision pain medicine context). It further presents a set of evidence-based recommendations for accelerating the application of precision pain methods in chronic pain research. PERSPECTIVE: Given the considerable variability in treatment outcomes for chronic pain, progress in precision pain treatment is critical for the field. An array of phenotypes and mechanisms contribute to chronic pain; this review summarizes current knowledge regarding which treatments are most effective for patients with specific biopsychosocial characteristics.
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Dolor Crónico , Humanos , Dolor Crónico/psicología , Analgésicos/uso terapéutico , Manejo del Dolor , Fenotipo , Dimensión del Dolor/métodosRESUMEN
BACKGROUND: Both medical child abuse (MCA) and central sensitization (CS) may present in adolescents with chronic pain, disability, high healthcare utilization, and unremarkable medical evaluations. OBJECTIVE: This study aimed to identify themes in the clinical narratives of adolescents with chronic pain that may help differentiate MCA from CS. PARTICIPANTS AND SETTING: Participants were 28 adolescents (ages 13-18 years) with chronic pain referred to either the Child Abuse Pediatrics team or the Pediatric Pain Medicine team at a tertiary children's hospital between 2011 and 2019, and diagnosed with MCA or CS, respectively. METHODS: This was a qualitative, retrospective study. Qualitative themes were derived through a process of inductive content analysis utilizing open coding, grouping, and secondary review by an interdisciplinary panel of experts. The relative prevalence of each code, theme, and overarching category was examined between groups to identify areas of convergence and divergence. RESULTS: Several themes appeared to be more prevalent in the MCA group (n = 9) compared to the CS group (n = 19). These included sick identity, homeschooling, caregiver with mental health disorder, maternal catastrophizing, maternal misrepresentation, persistence in healthcare-seeking, mandated reports made, medical neglect, and unnecessary and harmful medical care. CONCLUSIONS: This exploratory work identified themes from the clinical narratives of adolescents with chronic pain that may help differentiate MCA from CS. A visual reference, two illness scripts, and management recommendations are presented to aid pediatric providers in facilitating appropriate referrals for adolescents with chronic pain and disability out of proportion to diagnostic workup.
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Maltrato a los Niños , Dolor Crónico , Adolescente , Sensibilización del Sistema Nervioso Central , Niño , Humanos , Investigación Cualitativa , Estudios RetrospectivosRESUMEN
Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain.
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Dolor Crónico , Adolescente , Niño , Dolor Crónico/terapia , Ensayos Clínicos como Asunto , Consenso , Técnica Delphi , Humanos , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Resultado del TratamientoRESUMEN
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.
RESUMEN
Fewer randomized clinical trials (RCTs) are conducted for chronic or recurrent pain in pediatric populations compared with adult populations; thus, data to support treatment efficacy in children are limited. This article evaluates the design features and reporting practices of RCTs for chronic and recurrent pain that are likely unique to, or particularly important in, a pediatric population to promote improvements in the evidence base for pediatric pain treatments. Areas covered include outcome measure selection and reporting and reporting of adverse events and challenges to recruitment and retention. A search of PubMed and EMBASE identified primary publications describing RCTs of treatments for select chronic and recurrent pain conditions in children or adolescents published between 2000 and 2017. Only 49% of articles identified a primary outcome measure. The primary outcome measure assessed pain intensity in 38% of the trials, specifically measure by verbal rating scale (13%), faces pain scale (11%), visual analogue scale (9%), or numeric rating scale (5%). All of the CONSORT harms reporting recommendations were fulfilled by <50% of the articles. Discussions of recruitment challenges occurred in 64% of articles that enrolled <90% of their target sample. However, discussions regarding retention challenges only occurred in 14% of trials in which withdrawal rates were >10%. The goal of this article is to promote comprehensive reporting of pediatric pain RCTs to improve the design of future trials, facilitate conduction of systematic reviews and meta-analyses, and better inform clinical practice. PERSPECTIVE: This review of chronic and recurrent pediatric pain trials demonstrates inadequacies in the reporting quality of key features specifically important to pediatric populations. It provides recommendations that address these shortcomings to promote continued efforts toward improving the quality of the design and publication of future pediatric clinical pain trials.
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Ensayos Clínicos como Asunto , Metaanálisis en Red , Evaluación de Resultado en la Atención de Salud , Manejo del Dolor , Dolor , Pediatría , Proyectos de Investigación , Niño , HumanosRESUMEN
Clinical trials to test the safety and efficacy of analgesics across all pediatric age cohorts are needed to avoid inappropriate extrapolation of adult data to children. However, the selection of acute pain models and trial design attributes to maximize assay sensitivity, by pediatric age cohort, remains problematic. Acute pain models used for drug treatment trials in adults are not directly applicable to the pediatric age cohorts-neonates, infants, toddlers, children, and adolescents. Developmental maturation of metabolic enzymes in infants and children must be taken into consideration when designing trials to test analgesic treatments for acute pain. Assessment tools based on the levels of cognitive maturation and behavioral repertoire must be selected as outcome measures. Models and designs of clinical trials of analgesic medications used in the treatment of acute pain in neonates, infants, toddlers, children, and adolescents were reviewed and discussed at an Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Pediatric Pain Research Consortium consensus meeting. Based on extensive reviews and continuing discussions, the authors recommend a number of acute pain clinical trial models and design attributes that have the potential to improve the study of analgesic medications in pediatric populations. Recommendations are also provided regarding additional research needed to support the use of other acute pain models across pediatric age cohorts.
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Dolor Agudo/tratamiento farmacológico , Envejecimiento , Analgésicos/uso terapéutico , Ensayos Clínicos como Asunto , Adolescente , Niño , Preescolar , Humanos , LactanteRESUMEN
This study aimed to describe utilization of opioid medications among infants, children, and adolescents on the inpatient setting. These data are needed to guide clinical trials and improve research methodologies, as well as to inform more about possible sources of opioid misuse in the United States. A retrospective chart review was conducted covering a span of 1 year, with a special focus on the prescription of opioids for long-term treatment of chronic pain. Opioid medications were prescribed for <5 days in most (75%) patients. Among those who were prescribed opioids for >14 days, the focus was often for reasons other than pain. These data indicate that models of chronic pain that may be utilized in clinical trials of longer-term opioid usage in pediatrics are exceedingly limited. In addition, the patterns of utilization indicate that opioid administration among pediatric inpatients is not a likely contributory factor to concerns about opioid misuse in the United States. PERSPECTIVE: This article presents data on the administration of opioids in a major children's hospital, with a special eye toward usage beyond treatment for short-term acute pain. These data are important to better inform discussions of research strategies for chronic pain, as well as concerns for misuse in the pediatric population.
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Analgésicos Opioides/administración & dosificación , Dolor Crónico/tratamiento farmacológico , Adolescente , Niño , Preescolar , Femenino , Hospitalización , Hospitales Pediátricos , Humanos , Lactante , Recién Nacido , Pacientes Internos , Masculino , Pautas de la Práctica en Medicina , Estudios Retrospectivos , Factores de TiempoRESUMEN
INTRODUCTION: The treatment of youth with chronic pain has improved in recent years. However, because pediatric chronic pain programs are not governed by international standards, the development and implementation of new initiatives may be limited. OBJECTIVES: The objectives of this study were to identify the features of programs as they exist at present and to determine what features they should have in an ideal state. METHODS: A web-based international survey was used to collect information. The survey contained 86 questions seeking respondent professional demographic data and information about the pain program with which the respondent was affiliated at the time (program organization, types of pain problem treated, professionals involved, services provided, size of the program, research, professional training, public education and advocacy, and funding sources). RESULTS: Respondents were 136 pediatric pain experts representing different specialties located in 12 countries. Most respondents indicated that ideal programs would have a multidisciplinary staff; provide a wide range of treatments for different chronic pain problems; integrate research, formal clinical training of specialists, and public education and advocacy into their activities; and be an accredited part of the public health system. CONCLUSIONS: The results of this survey may be useful for health care professionals interested in treating chronic pain in children and adolescents and for policy makers concerned with improving the care given to these children and their families.
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Dolor Crónico , Trastornos Relacionados con Opioides , Analgésicos Opioides/efectos adversos , Niño , Dolor Crónico/tratamiento farmacológico , Humanos , Epidemia de Opioides , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/prevención & control , PrescripcionesRESUMEN
UNLABELLED: An ideal taxonomy of chronic pain would be applicable to people of all ages. Developmental sciences focus on lifespan developmental approaches, and view the trajectory of processes in the life course from birth to death. In this article we provide a review of lifespan developmental models, describe normal developmental processes that affect pain processing, and identify deviations from those processes that lead to stable individual differences of clinical interest, specifically the development of chronic pain syndromes. The goals of this review were 1) to unify what are currently separate purviews of "pediatric pain," "adult pain," and "geriatric pain," and 2) to generate models so that specific elements of the chronic pain taxonomy might include important developmental considerations. PERSPECTIVE: A lifespan developmental model is applied to the forthcoming Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks-American Pain Society Pain Taxonomy to ascertain the degree to which general "adult" descriptions apply to pediatric and geriatric populations, or if age- or development-related considerations need to be invoked.
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Envejecimiento , Dolor Crónico , Geriatría , Pediatría , Dolor Crónico/diagnóstico , Dolor Crónico/epidemiología , Dolor Crónico/terapia , Desarrollo Humano , Humanos , Manejo del DolorRESUMEN
UNLABELLED: Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. The American Pain Society, with input from the American Society of Anesthesiologists, commissioned an interdisciplinary expert panel to develop a clinical practice guideline to promote evidence-based, effective, and safer postoperative pain management in children and adults. The guideline was subsequently approved by the American Society for Regional Anesthesia. As part of the guideline development process, a systematic review was commissioned on various aspects related to various interventions and management strategies for postoperative pain. After a review of the evidence, the expert panel formulated recommendations that addressed various aspects of postoperative pain management, including preoperative education, perioperative pain management planning, use of different pharmacological and nonpharmacological modalities, organizational policies, and transition to outpatient care. The recommendations are based on the underlying premise that optimal management begins in the preoperative period with an assessment of the patient and development of a plan of care tailored to the individual and the surgical procedure involved. The panel found that evidence supports the use of multimodal regimens in many situations, although the exact components of effective multimodal care will vary depending on the patient, setting, and surgical procedure. Although these guidelines are based on a systematic review of the evidence on management of postoperative pain, the panel identified numerous research gaps. Of 32 recommendations, 4 were assessed as being supported by high-quality evidence, and 11 (in the areas of patient education and perioperative planning, patient assessment, organizational structures and policies, and transitioning to outpatient care) were made on the basis of low-quality evidence. PERSPECTIVE: This guideline, on the basis of a systematic review of the evidence on postoperative pain management, provides recommendations developed by a multidisciplinary expert panel. Safe and effective postoperative pain management should be on the basis of a plan of care tailored to the individual and the surgical procedure involved, and multimodal regimens are recommended in many situations.
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Manejo del Dolor/normas , Dolor Postoperatorio/terapia , Guías de Práctica Clínica como Asunto/normas , Sociedades Médicas/normas , HumanosRESUMEN
Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.
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Dolor Crónico , Ensayos Clínicos como Asunto/métodos , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Resultado en la Atención de Salud/normas , Manejo del Dolor/métodos , Resultado del Tratamiento , Dolor Crónico/fisiopatología , Dolor Crónico/psicología , Dolor Crónico/terapia , Humanos , Manejo del Dolor/normas , Dimensión del Dolor/métodos , Calidad de Vida/psicología , Participación Social/psicologíaRESUMEN
BACKGROUND: Preterm and full-term neonates admitted to the neonatal intensive care unit or elsewhere in the hospital are routinely subjected to invasive procedures that can cause acute pain. Despite published data on the complex behavioral, physiologic, and biochemical responses of these neonates and the detrimental short- and long-term clinical outcomes of exposure to repetitive pain, clinical use of pain-control measures in neonates undergoing invasive procedures remains sporadic and suboptimal. As part of the Newborn Drug Development Initiative, the US Food and Drug Administration and the National Institute of Child Health and Human Development invited a group of international experts to form the Neonatal Pain Control Group to review the therapeutic options for pain management associated with the most commonly performed invasive procedures in neonates and to identify research priorities in this area. OBJECTIVE: The goal of this article was to review and synthesize the published clinical evidence for the management of pain caused by invasive procedures in preterm and full-term neonates. METHODS: Clinical studies examining various therapies for procedural pain in neonates were identified by searches of MEDLINE (1980-2004), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2004), the reference lists of review articles, and personal files. The search terms included specific drug names, infant-newborn, infant-preterm, and pain, using the explode function for each key word. The English-language literature was reviewed, and case reports and small case series were discarded. RESULTS: The most commonly performed invasive procedures in neonates included heel lancing, venipuncture, IV or arterial cannulation, chest tube placement, tracheal intubation or suctioning, lumbar puncture, circumcision, and SC or IM injection. Various drug classes were examined critically, including opioid analgesics, sedative/hypnotic drugs, nonsteroidal anti-inflammatory drugs and acetaminophen, injectable and topical local anesthetics, and sucrose. Research considerations related to each drug category were identified, potential obstacles to the systematic study of these drugs were discussed, and current gaps in knowledge were enumerated to define future research needs. Discussions relating to the optimal design for and ethical constraints on the study of neonatal pain will be published separately. Well-designed clinical trials investigating currently available and new therapies for acute pain in neonates will provide the scientific framework for effective pain management in neonates undergoing invasive procedures.
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Analgesia/métodos , Anestesia Local/métodos , Dolor Postoperatorio/prevención & control , Humanos , Recién NacidoRESUMEN
OBJECTIVE: The purpose of this article is to summarize the clinical, methodologic, and ethical considerations for researchers interested in designing future trials in neonatal analgesia and anesthesia, hopefully stimulating additional research in this field. METHODS: The MEDLINE, PubMed, EMBASE, and Cochrane register databases were searched using subject headings related to infant, newborn, neonate, analgesia, anesthesia, ethics, and study design. Cross-references and personal files were searched manually. Studies reporting original data or review articles related to these topics were assessed and critically evaluated by experts for each topical area. Data on population demographics, study characteristics, and cognitive and behavioral outcomes were abstracted and synthesized in a systematic manner and refined by group members. Data synthesis and results were reviewed by a panel of independent experts and presented to a wider audience including clinicians, scientists, regulatory personnel, and industry representatives at the Newborn Drug Development Initiative workshop. Recommendations were revised after extensive discussions at the workshop and between committee members. RESULTS: Designing clinical trials to investigate novel or currently available approaches for analgesia and anesthesia in neonates requires consideration of salient study designs and ethical issues. Conditions requiring treatment include pain/stress resulting from invasive procedures, surgical operations, inflammatory conditions, and routine neonatal intensive care. Study design considerations must define the inclusion and exclusion criteria, a rationale for stratification, the confounding effects of comorbid conditions, and other clinical factors. Significant ethical issues include the constraints of studying neonates, obtaining informed consent, making risk-benefit assessments, defining compensation or rewards for participation, safety considerations, the use of placebo controls, and the variability among institutional review boards in interpreting federal guidelines on human research. For optimal study design, investigators must formulate well-defined study questions, choose appropriate trial designs, estimate drug efficacy, calculate sample size, determine the duration of the studies, identify pharmacokinetic and pharmacodynamic parameters, and avoid drug-drug interactions. Specific outcome measures may include scoring on pain assessment scales, various biomarkers and their patterns of response, process outcomes (eg, length of stay, time to extubation), intermediate or long-term outcomes, and safety parameters. CONCLUSIONS: Much more research is needed in this field to formulate a scientifically sound, evidence-based, and clinically useful framework for management of anesthesia and analgesia in neonates. Newer study designs and additional ethical dilemmas may be defined with accumulating data in this field.
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Analgesia/métodos , Anestesia/métodos , Ensayos Clínicos como Asunto/métodos , Analgesia/ética , Anestesia/ética , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/normas , Humanos , Recién NacidoRESUMEN
OBJECTIVES: To examine the relationship among different indicators of pain and distress, including self-report, behavioral observations, and physiological parameters, in children with cancer undergoing invasive procedures. METHODS: Forty-eight children between the ages of 3.1 and 17.7 years were evaluated while undergoing lumbar punctures. Self-report measures assessed anxiety, pain, self-efficacy, expectations of coping strategies, and coping self-efficacy. Parents reported on their own and their child's levels of anxiety, and physicians estimated their own level of stress and technical difficulty in completing the procedure. Behavioral observations were made prior to, during, and after the procedure. Physiological parameters included heart rate, cardiac vagal tone, and salivary cortisol. At the discretion of attending physicians, 32 children received deep sedation, 9 received light sedation, and 7 received cognitive-behavioral strategies with topical anesthetic as interventions to manage procedural distress. RESULTS: There was a high degree of consistency within self-report, behavioral, and physiological parameters, but correlations between measures in different modalities were low. There were floor effects for most behavioral and self-report measures of distress. Cortisol showed marked changes preprocedure to postprocedure, demonstrating high levels of physiological response despite lack of apparent or perceived discomfort. Heart rate was significantly lower in the group using cognitive-behavioral techniques, especially at the point of needle insertion. DISCUSSION: Self-report measures, behavioral indicators, and physiological changes are not interchangeable outcomes. Treatment strategies were effective for minimizing subjective and behavioral distress, but not necessarily for physiological reactions. Future research should focus on individual differences in these responses, and treatment outcome studies aimed at reducing distress must be clear about the specific goals of intervention.
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Adaptación Psicológica , Neoplasias/complicaciones , Neoplasias/psicología , Dolor/etiología , Estrés Psicológico/etiología , Adolescente , Autobiografías como Asunto , Niño , Preescolar , Recolección de Datos , Femenino , Frecuencia Cardíaca/fisiología , Humanos , Hidrocortisona/metabolismo , Masculino , Observación/métodos , Dimensión del Dolor , Saliva/metabolismoRESUMEN
BACKGROUND: Intra-articular corticosteroid injections (IACI) are routinely used by pediatric rheumatologists in the treatment of chronic arthritis. Frequently, topical anesthetics are used to control procedural pain, but their relative efficacy has not been reported. In this study, we evaluated the level of pain associated with different anesthetic methods, Numby® 900 Iontophoretic Drug Delivery System, or EMLA® cream, with or without subcutaneous buffered lidocaine (SQBL), during IACI of the knee in children with arthritis. METHODS: We conducted a prospective study of patients, ages 4 to 21 years old, followed at three pediatric rheumatology centers who were undergoing IACI of a knee joint. Patients were randomized into two treatment groups: 1) topical anesthetic only (EMLA® or Numby® (E/N)), or 2) topical anesthetic (E/N) and SQBL. Pain was assessed at baseline, during topical anesthetic placement, and following the IACI (post-procedure). The Faces Pain Scale-Revised (FPS-R), the Face, Leg, Activity, Cry, Consolability (FLACC) behavioral scale and the parental global assessment (PGA) (0 = best experience, 10 = worst experience) were determined. RESULTS: Sixty-three patients (44 females) with a median [IQR] age of 10.8 [IQR = (8.2-14.4)] years (range 4.7-20 years) with active knee arthritis were consented. FPS-R post-procedure (P = 0.03), FLACC (P = 0.02) and PGA (P = 0.01) scores were significantly lower in females treated with E/N plus SQBL compared to patients treated with E/N only. Females in the E/N only group had a significant worsening of their baseline pain (p < 0.0004) and a greater magnitude of change in their baseline FPS-R scores (p < 0.001) from the procedure compared to females in the E/N plus SQBL group who had no worsening of their baseline pain. No significant change in pain level or PGA score was found among males in either treatment group. Pain scores overall were similar to the oligoarthritis patients, a more homogeneous group of patients. Both EMLA® (n = 33) and Numby® (n = 29) were equally well tolerated with no significant difference in median FPS-R administration scores overall. CONCLUSION: Our results suggest that a topical anesthetic plus SQBL is more effective for injection pain control than topical anesthesia only. Further studies addressing pain and anxiety will help determine the optimal method of pain control for IACI.
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Corticoesteroides/administración & dosificación , Anestesia Local/métodos , Artritis Juvenil/tratamiento farmacológico , Inyecciones Intraarticulares , Manejo del Dolor/métodos , Adolescente , Corticoesteroides/uso terapéutico , Niño , Preescolar , Femenino , Humanos , Inyecciones Intraarticulares/métodos , Iontoforesis/métodos , Masculino , Dimensión del Dolor , Adulto JovenRESUMEN
Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.