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Medical cannabis (MC) may offer therapeutic benefits for children with complex neurological conditions and chronic diseases. In Canada, parents, and caregivers frequently report encountering barriers when accessing MC for their children. These include negative preconceived notions about risks and benefits, challenges connecting with a knowledgeable healthcare provider (HCP), the high cost of MC products, and navigating MC product shortages. In this manuscript, we explore several of these barriers and provide recommendations to decision-makers to enable a family-centered and evidence-based approach to MC medicine and research for children.
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After decades on the margins of primary health care, surgical and anaesthesia care is gaining increasing priority within the global development arena. The 2015 publications of the Disease Control Priorities third edition on Essential Surgery and the Lancet Commission on Global Surgery created a compelling evidenced-based argument for the fundamental role of surgery and anaesthesia within cost-effective health systems strengthening global strategy. The launch of the Global Alliance for Surgical, Obstetric, Trauma, and Anaesthesia Care in 2015 has further coordinated efforts to build priority for surgical care and anaesthesia. These combined efforts culminated in the approval of a World Health Assembly resolution recognizing the role of surgical care and anaesthesia as part of universal health coverage. Momentum gained from these milestones highlights the need to identify consensus goals, targets and indicators to guide policy implementation and track progress at the national level. Through an open consultative process that incorporated input from stakeholders from around the globe, a global target calling for safe surgical and anaesthesia care for 80% of the world by 2030 was proposed. In order to achieve this target, we also propose 15 consensus indicators that build on existing surgical systems metrics and expand the ability to prioritize surgical systems strengthening around the world.
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Anestesia , Accesibilidad a los Servicios de Salud , Obstetricia , Procedimientos Quirúrgicos Operativos , Heridas y Lesiones/cirugía , Creación de Capacidad , Consenso , Salud Global , Objetivos , HumanosRESUMEN
Objective. The purpose of this study was to explore the research on the delivery and evaluation of pediatric health services by non-governmental organizations in low-and middle-income countries to better understand how they contribute to positive and sustainable health outcomes. Methods. A scoping review was completed using a 2-step study selection procedure. Results. Of the 5742 studies, 17 met criteria, including quantitative and mixed method designs, representing 10 different non-governmental organizations with programs in 33 low-and middle-income countries. Health outcomes were reported 89 times across the studies. A total of 56 different outcomes were identified in total, of which 24 were positive, 27 were negative, and 5 were unchanged. Conclusions. Widespread variation between non-governmental organizations exist, however, comprehensive pediatric health outcome evaluation is growing. Further emphasis should be given to adolescent specific research and robust measurement of quality of life.
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OBJECTIVE: To examine the incidence and prevalence of pediatric inflammatory bowel disease (IBD) during 1996-2006 in a community-based health-care delivery system. STUDY DESIGN: Members of Kaiser Permanente Northern California aged 0 to 17 years with IBD were identified by use of computerized medical information with confirmation obtained through review of the medical record. RESULTS: The average annual incidence of IBD per 100000 was 2.7 (95% confidence interval [CI], 2.3-3.1) for Crohn's disease (CD) and 3.2 (CI, 2.8-3.6) for ulcerative colitis (UC). During the 11-year study period, the annual incidence per 100000 increased from 2.2 to 4.3 for CD (P = .09) and from 1.8 to 4.9 for UC (P < .001). The ratio of incident CD cases to incident UC cases was 0.9 in non-Hispanic whites, 1.6 in African Americans (P = .12), 0.3 in Hispanics (P < .001) and 0.4 in Asians (P = .04). The average length of enrollment during the 11-year study period exceeded 8 years. The point prevalence on December 31, 2006, per 100000 was 12.0 for CD (CI, 9.6-14.4) and 19.5 (CI, 16.5-22.6) for UC. CONCLUSIONS: In this population the incidence of UC increased significantly by 2.7-fold and CD increased 2.0-fold without reaching statistical significance. Hispanic and Asian children had development of UC more often than CD, suggesting possible etiologic differences across racial and ethnic groups.
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Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/epidemiología , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/epidemiología , Adolescente , California , Niño , Preescolar , Servicios de Salud Comunitaria/estadística & datos numéricos , Etnicidad , Gastroenterología/métodos , Humanos , Incidencia , Lactante , Recién Nacido , Enfermedades Inflamatorias del Intestino/diagnóstico , Enfermedades Inflamatorias del Intestino/epidemiología , Pediatría/métodos , PrevalenciaRESUMEN
The goal of this project is to augment clinician communication by connecting it to evidence-based research, providing explicit knowledge to corroborate the experiential knowledge shared between health care practitioners. The source of tacit knowledge sharing is the Pediatric Pain Mailing List (PPML), a forum for practicing clinicians to contact peers on the subject of pain in children. The messages, dating back to 1993, are processed for pertinent information and gathered together into threads. They are then parsed and connected to a set of MeSH keywords, which is used to search Pubmed and return a set of papers that correspond to the subject being discussed. The results are presented in an online forum, providing clinicians with an arena in which they can browse the archives of the PPML and connect those conversations to pertinent medical literature.
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Almacenamiento y Recuperación de la Información/métodos , Manejo del Dolor , Niño , Toma de Decisiones Asistida por Computador , Personal de Salud , Humanos , Medical Subject Headings , PubMedRESUMEN
BACKGROUND: A number of infant pain measures have been developed over the past 15 years incorporating behavioural and physiologic indicators; however, no reliable or valid measure exists for infants who are at risk for neurological impairments (NI). The objective of this study was to establish consensus about which behavioural, physiologic and contextual indicators best characterize pain in infants at high, moderate and low levels of risk for NI. METHODS: A 39- item, self-administered electronic survey that included infant physiologic, behavioral and contextual pain indicators was used in a two round Delphi consensus exercise. Fourteen pediatric pain experts were polled individually and anonymously on the importance and usefulness of the pain indicators for the 3 differing levels of risk for NI. RESULTS: The strength of agreement between expert raters was moderate in Round 1 and fair in Round 2. In general, pain indicators with the highest concordance for all three groups were brow bulge, facial grimace, eye squeeze, and inconsolability. Increased heart rate from baseline in the moderate and severe groups demonstrated high concordance. In the severe risk group, fluctuations in heart rate and reduced oxygen saturation were also highly rated. CONCLUSION: These data constitute the first step in contributing to the development and validation of a pain measure for infants at risk for NI. In future research, we will integrate these findings with the opinions of (a) health care providers about the importance and usefulness of infant pain indicators and (b) the pain responses of infants at mild, moderate and high risk for NI.
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Actitud del Personal de Salud , Conducta del Lactante , Enfermedades del Sistema Nervioso/etiología , Dimensión del Dolor/métodos , Técnica Delphi , Humanos , Lactante , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To provide a better understanding of the prevalence, correlates and quality of phantom sensations and phantom pain in child and adolescent amputees. DESIGN: Retrospective survey study. SETTING: Recruitment through the War Amputations of Canada. PARTICIPANTS: Sixty child and adolescent amputees aged 8-18 years who were missing a limb due to a congenital limb deficiency (n = 27) or surgery/trauma (n = 33). MAIN OUTCOME MEASURE(S): Questionnaire to assess the occurrence and correlates of phantom sensations and phantom pain. RESULTS: Forty-two percent of the total sample reported phantom sensations; 7.4% of the congenital group and 69.7% of the surgical group (chi2 = 23.70 with 1 df, P < 0.01.) Twenty-nine percent of the total sample reported phantom pain; 3.7% of the congenital group and 48.5% of the surgical group (chi2 = 14.67, with 1 df, P < 0.01). Eighty-eight percent of the amputees with phantom pain had stump pain, while 35.3% had phantom pain that was similar to pre-operative pain and 76.5% experienced pains other than phantom pain (e.g. headaches). Amputees identified exercise, objects approaching the stump, cold weather and 'feeling nervous' as the primary triggers of phantom sensations and/or phantom pain. CONCLUSION(S): Less than half of the sample experienced phantom sensations and phantom pain; however, the loss of a limb due to surgery is associated with an increase in the likelihood of experiencing these phenomena.
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Amputados , Deformidades Congénitas de las Extremidades/fisiopatología , Miembro Fantasma/fisiopatología , Adolescente , Niño , Extremidades/lesiones , Femenino , Humanos , Masculino , Estudios RetrospectivosRESUMEN
Pain assessment is a difficult task for parents at home following children's surgery. The purpose of the present study was to confirm the psychometric properties of a behavioural measure of postoperative pain developed to assist parents with pain assessment in children aged 7-12 years following day surgery. The study also examined the reliability and validity of the measure with children aged 2-6 years. Participants were 51 parents of children aged 7-12 years and 107 parents of children aged 2-6 years. For the 2 days following surgery, parents completed a pain diary that included global ratings of their children's pain and the 15-item Parents' Postoperative Pain Measure (PPPM). The older children provided self-reports of their pain intensity. The PPPM items showed good internal consistency on the two postoperative days for both samples (alpha's=0.81-0.88) and scores on the PPPM were highly correlated with children's (for the older children) and parents' (for the young children) global ratings of pain (r's=0.53-0.72). As global pain ratings decreased from Days 1 to 2, so did scores on the PPPM. Scores on the PPPM were successful in discriminating between children who had undergone low/moderate and high pain surgeries. The results of this study provide evidence of the reliability and validity of the PPPM as a measure of postoperative pain among children aged 2 through to 12 years.
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Dimensión del Dolor/métodos , Dolor Postoperatorio/diagnóstico , Relaciones Padres-Hijo , Adulto , Análisis de Varianza , Niño , Preescolar , Femenino , Humanos , Masculino , PsicometríaRESUMEN
The aim of the investigation was to evaluate the prevalence, severity, and parents' management of children's pain following short-stay and day surgery. The subjects were 189 parents of children (2-12 years of age) who had undergone short-stay or day surgery. Parents completed a 3-day diary of their child's pain and the methods used to alleviate it. There were clear differences in pain reported according to type of surgery. Some surgery, such as insertion of myringotomy tubes, appeared to cause little pain. Other procedures, including tonsillectomy, circumcision, and strabismus repair, resulted in about one-half the children experiencing clinically significant pain (> or = 30 mm on a 100 mm VAS). Sixty-eight percent of the parents reported they had been instructed to use acetaminophen for pain 'if necessary', 13% had been told to use acetaminophen regularly, and 8% recalled no instructions. Of the parents who rated their child's pain as significant, 13% administered no pain medication and 47% gave 1-3 doses on day 2. On day 3, 17% gave no medication and 45% gave 1-3 doses. Some types of 'minor' surgery result in significant pain postoperatively. Even when parents recognise that their children are in pain, most give inadequate doses of medication to control the pain.
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Cuidadores , Dolor Postoperatorio/tratamiento farmacológico , Cuidados Paliativos , Padres , Acetaminofén/administración & dosificación , Acetaminofén/uso terapéutico , Adolescente , Adulto , Actitud , Niño , Preescolar , Femenino , Humanos , Masculino , Registros Médicos , Persona de Mediana Edad , Dimensión del Dolor , Dolor Postoperatorio/epidemiología , Dolor Postoperatorio/fisiopatologíaRESUMEN
Our knowledge of the prevalence and sources of pain within hospital is limited. The present study is an epidemiological investigation of pain in a pediatric hospital. All children who were inpatients in a tertiary care hospital (excluding Neonatal ICU and psychiatry patients) and one parent per child were potential subjects. Interviews were conducted on three weekdays. Parent interviews were used for children less than 5 years of age (n = 102); child interviews were used for children age 5 years and older (n = 98). Subjects reported the intensity and source of the worst, usual and current pain during the past 24 h, and help received for pain. Medical and demographic variables and analgesics prescribed and administered were obtained from the medical record. Forty-nine percent of subjects reported clinically significant levels of worst pain. Twenty-one percent of subjects had clinically significant levels of usual pain. Causes of pain were variable and included disease, surgery, and intravenous lines (I.V.). Pain intensity was not significantly related to age, gender, patient type (medical, surgical), or diagnostic category. Children were given significantly less medication than was prescribed, regardless of their reported pain level. Nurses, mothers, and 'no-one' were frequently reported as helping with pain. Medications and nonpharmacological methods were reported as helpful in managing pain. Many children endure unacceptable levels of pain during hospitalization. Pain prevention and management must be more aggressive. Pain assessment should be approached with the same attention as vital signs. Improvements in analgesic prescription and administration practices and non-pharmacological pain control methods are needed.
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Dolor/epidemiología , Adolescente , Adulto , Analgésicos , Niño , Preescolar , Prescripciones de Medicamentos , Femenino , Hospitales Pediátricos , Humanos , Lactante , Recién Nacido , Masculino , Dolor/etiología , Pautas de la Práctica en Medicina , PrevalenciaRESUMEN
In the past decade, our knowledge of pain in newborn infants has advanced considerably. However, infants at significant risk for neurologic impairment (NI) have been systematically excluded from almost all research on pain in neonates. The objectives of this study were to compare: (a). the nature, frequency and prevalence of painful procedures, (b). analgesics and sedatives administered, and (c). the relationship between painful procedures and analgesia for neonates at risk for NI. One hundred and ninety-four infants at high (cohort A, n=67), moderate (cohort B, n=59) and low (cohort C, n=68) risk for NI from two tertiary level Neonatal Intensive Care Unit's in Canada were included in a retrospective cohort study on the first 7 days of life. Data were collected from medical records and analyzed using chi-square, ANOVA and regression approaches. All cohorts had a mean of >10 painful procedures per day during the first 2 days of life. There was an interaction effect between cohort group and day of life (F(5,188)=2.13, P<0.06) with cohort A having significantly more painful procedures on day 1 (F(2,191)=4.79, P<0.009). There was no statistical difference in the number of infants who received continuous infusion (F(2,20)=1.9, P=0.13) or bolus (F(2,20)=1.3, P=0.25) opioids or sedatives (F(2,20)=0.45, P=0.84) by cohort over the 7 day period. There was a statistical difference in bolus opioid administration for days 1 (P<0.05) and 2 (P<0.001) with less than 10% of infants in cohort A receiving bolus opioids compared with approximately 22-33% of infants in cohorts B and C. There was a statistically significant correlation between painful procedures and analgesic use (r=0.29, P<0.001), although significant associations existed for cohorts B and C only. The number of painful procedures and study site primarily accounted for the variance (61% in cohort B and 35% in cohort C) in analgesic use, while in cohort A, only study site contributed to the variance (16%). Neonates at the highest risk for NI had the greatest number of painful procedures and the least amount of opioids administered during the first day of life. There was no relationship between painful procedures and analgesic use in this group. As these infants are vulnerable to pain and its consequences, the rational underlying health professional strategies regarding painful procedures and analgesic use for procedural pain in this population urgently awaits exploration.
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Pruebas Diagnósticas de Rutina/efectos adversos , Pruebas Diagnósticas de Rutina/estadística & datos numéricos , Enfermedades del Sistema Nervioso/etiología , Dolor/etiología , Analgésicos Opioides/administración & dosificación , Estudios de Cohortes , Esquema de Medicación , Fentanilo/administración & dosificación , Humanos , Hipnóticos y Sedantes/administración & dosificación , Recién Nacido , Bombas de Infusión , Morfina/administración & dosificación , Dolor/prevención & control , Manejo del Dolor , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: The electroencephalogram (EEG) reflects the electrical activity in the brain on the surface of scalp. A major challenge in this field is the localization of sources in the brain responsible for eliciting the EEG signal measured at the scalp. In order to estimate the location of these sources, one must correctly model the sources, i.e., dipoles, as well as the volume conductor in which the resulting currents flow. In this study, we investigate the effects of dipole depth and orientation on source localization with varying sets of simulated random noise in 4 realistic head models. METHODS: Dipole simulations were performed using realistic head models and using the boundary element method (BEM). In all, 92 dipole locations placed in temporal and parietal regions of the head with varying depth and orientation were investigated along with 6 different levels of simulated random noise. Localization errors due to dipole depth, orientation and noise were investigated. RESULTS: The results indicate that there are no significant differences in localization error due tangential and radial dipoles. With high levels of simulated Gaussian noise, localization errors are depth-dependent. For low levels of added noise, errors are similar for both deep and superficial sources. CONCLUSION: It was found that if the signal-to-noise ratio is above a certain threshold, localization errors in realistic head models are, on average the same for deep and superficial sources. As the noise increases, localization errors increase, particularly for deep sources.
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Artefactos , Mapeo Encefálico/métodos , Electroencefalografía/métodos , Encéfalo/fisiología , Mapeo Encefálico/instrumentación , Simulación por Computador , Impedancia Eléctrica , Electrodos , Humanos , Potenciales de la Membrana , Modelos Anatómicos , Distribución Normal , Lóbulo Parietal/fisiopatología , Cuero Cabelludo , Propiedades de Superficie , Lóbulo Temporal/fisiopatologíaRESUMEN
Clinical decision-making can be vastly improved with the availability of the right medical knowledge at the right time. This concept paper presents a knowledge management re-search program to (a) identify, capture and organize the tacit knowledge inherent within on-line problem-solving discussions between pediatric pain practitioners; (b) establish linkages between topic-specific pediatric pain discussions and corresponding published medical literature on children's pain available at PubMed--i.e. linking tacit expert knowledge to explicit medical literature; and (c) make these knowledge re-sources available to pediatric pain practitioners via the WWW for timely access to various modalities of clinical knowledge.
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Toma de Decisiones Asistida por Computador , Gestión de la Información/métodos , Sistemas en Línea , Manejo del Dolor , Inteligencia Artificial , Niño , Humanos , Gestión de la Información/organización & administración , Medical Subject Headings , Sistemas en Línea/organización & administración , PubMed , Integración de SistemasRESUMEN
Adolescents with chronic pain are at risk for impairment in their friendships. They miss out on leisure activities, have increased school absence, may have fewer friends, are at an increased risk for victimization, and may be perceived by peers as less likeable. To help determine the source of these problems, the Social Information Processing Model (SIP) was adapted using narrative vignettes to determine if adolescents with chronic pain interpret friendship interactions differently in terms of supportive and nonsupportive behaviors compared to healthy peers. One hundred seven adolescents, 45 with chronic pain, completed the vignette questionnaire and a battery of measures. The vignette questionnaire included 12 vignettes to capture 3 steps in SIP processing: interpretation of cues, response construction, and response decision. Participants with chronic pain rated nonsupportive vignettes more negatively than healthy controls and indicated they would enact supportive behaviors towards the chronic pain character more often if they had been the healthy character. Age, sex, and internalizing measures did not significantly contribute to the findings. Chronic pain explained 6.5% of variance in the ratings of nonsupportive vignettes and 10.1% of the variance in supportive behavior selection. Adolescents with chronic pain may interpret nonsupportive social situations with close friends as more distressing. The endorsement of more supportive behaviors may indicate a need for, and expectation of, supportive behaviors from friends. When adolescents with chronic pain do not perceive friends as providing support, they may avoid these social situations.
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Conducta del Adolescente/psicología , Trastornos de Ansiedad/psicología , Dolor Crónico/psicología , Trastorno Depresivo/psicología , Conducta Social , Apoyo Social , Adolescente , Trastornos de Ansiedad/epidemiología , Dolor Crónico/epidemiología , Comorbilidad/tendencias , Trastorno Depresivo/epidemiología , Femenino , Amigos/psicología , Humanos , Soledad/psicología , MasculinoRESUMEN
BACKGROUND: There is a plethora of infant pain measures; however, none of them have been validated for extremely low for gestational age (ELGA) infants (<27 weeks' gestation). To date, clinicians, researchers and parents use information gleaned from more mature infants to make inferences about pain in ELGA infants. Using physiological or behavioral pain indicators derived from more mature infants may lead to inaccurate assessments and management. OBJECTIVES: To compare physiological (heart rate, oxygen saturation) and behavioral (9 facial activities, cry) pain indicators of ELGA infants with infants of varying more mature gestational ages (GAs). METHODS: The aim was to determine the effects of GA on pain response. GA was categorized into four mutually exclusive strata: <27 6/7 weeks, 28-31 6/7 weeks, 32-35 6/7 weeks and >36 weeks. Physiological data during four phases of a routine heel lance were collected by placing disposable ECG electrodes and pulse oximetry probes on the infant's chest. Behavioral data were collected by videotaping facial activities, and cry data were collected by audio recording. RESULTS: Four facial activities (brow bulge, eye squeeze, nasolabial furrow, vertical mouth stretch) in response to acute pain were present in ELGA infants. Facial activities increased following painful procedures and the magnitude of responses was proportional to GA with the youngest infants (<27 6/7 weeks GA) showing the least amount of change. Decreased oxygen saturation and increased heart rate were associated with the most invasive phase of the heel lance; however, the differences were neither clinically or statistically significant across age groups. Cry was not a sensitive pain indicator in ELGA infants, due to the presence of endotracheal tubes in this high-risk population. DISCUSSION: ELGA infants have similar pain responses to older infants, but the responses are dampened. Other factors such as severity of illness, frequency of painful procedures or medication use should be examined, as they may influence the pain responses in ELGA infants.
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Conducta del Lactante/fisiología , Recien Nacido Prematuro/fisiología , Recién Nacido de muy Bajo Peso/fisiología , Dimensión del Dolor , Estudios de Cohortes , Expresión Facial , Femenino , Edad Gestacional , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Cuidado Intensivo Neonatal/normas , Masculino , Dolor/fisiopatología , Dimensión del Dolor/normasRESUMEN
BACKGROUND: Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A), which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. METHODS/DESIGN: The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5-21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont). Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group) intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. DISCUSSION: BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the context of limb lengthening and deformity correction. TRIAL REGISTRATION: NCT00412035.
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Multiple researchers have validated indicators and measures of infant pain. However, infants at risk for neurologic impairment (NI) have been under studied. Therefore, whether their pain responses are similar to those of other infants is unknown. Pain responses to heel lance from 149 neonates (GA>25-40 weeks) from 3 Canadian Neonatal Intensive Care units at high (Cohort A, n=54), moderate (Cohort B, n=45) and low (Cohort C, n=50) risk for NI were compared in a prospective observational cohort study. A significant Cohort by Phase interaction for total facial action (F(6,409)=3.50, p=0.0022) and 4 individual facial actions existed; with Cohort C demonstrating the most facial action. A significant Phase effect existed for increased maximum Heart Rate (F(3,431)=58.1, p=0.001), minimum Heart Rate (F(3,431)=78.7, p=0.001), maximum Oxygen saturation (F(3,425)=47.6, p=0.001), and minimum oxygen saturation (F(3,425)=12.2, p=0.001) with no Cohort differences. Cohort B had significantly higher minimum (F(2,79)=3.71, p=0.029), and mean (F(2,79)=4.04, p=0.021) fundamental cry frequencies. A significant Phase effect for low/high frequency Heart Rate Variability (HRV) ratio (F(2,216)=4.97, p=0.008) was found with the greatest decrease in Cohort A. Significant Cohort by Phase interactions existed for low and high frequency HRV. All infants responded to the most painful phase of the heel lance; however, infants at moderate and highest risk for NI exhibited decreased responses in some indicators.
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Conducta Infantil , Enfermedades del Sistema Nervioso/diagnóstico , Enfermedades del Sistema Nervioso/fisiopatología , Dimensión del Dolor/métodos , Dolor/diagnóstico , Dolor/fisiopatología , Medición de Riesgo/métodos , Canadá , Preescolar , Estudios de Cohortes , Femenino , Humanos , Recién Nacido , Masculino , Enfermedades del Sistema Nervioso/complicaciones , Dolor/complicaciones , Factores de RiesgoRESUMEN
BACKGROUND: The current study was conducted to assess the safety and tolerability of a transdermal fentanyl delivery system for the relief of chronic pain in a pediatric population, and also to validate titration recommendations and conversion to transdermal fentanyl from oral opioid therapy. METHODS: This 15-day (with 3-month extension), single-arm, open-label trial was conducted at 66 sites in 10 countries. A total of 199 pediatric patients (ages 2-16 years) with both malignant and nonmalignant conditions who were receiving oral or parenteral opioids for moderate to severe chronic pain were enrolled. Transdermal fentanyl doses were titrated upward according to the rescue medication consumed during the previous application period. Degree of pain was assessed by patients and parents/guardians using visual and numeric scales. Level of play and quality of life were assessed using the Play Performance Scale (PPS) and the Child Health Questionnaire (CHQ). Adverse events were monitored on Days 1-15. Hypoventilation and sedation were monitored every 4 hours during the first 72 hours of the study. RESULTS: A total of 173 patients completed the primary treatment period and 130 entered the extension phase. The average daily pain intensity scores were reported to have decreased by Day 16 and improvements in the mean PPS scores were observed to the end of the extension period. The CHQ scores demonstrated improvements in 11 of 12 domains after Month 1 of the extension period. CONCLUSIONS: Transdermal fentanyl was found to be a safe and well tolerated alternative to oral opioid treatment for children ages 2-16 years who were previously exposed to opioid therapy.