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OBJECTIVE: For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS. METHODS: This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established. RESULTS: 14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option-Persistent spinal pain syndrome-was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification. CONCLUSIONS: This project is important to those in the fields of pain management, spine surgery, and neuromodulation, as well as patients labeled with FBSS. Through a shift in perspective, it could facilitate the application of the new ICD-11 classification and allow clearer discussion among medical professionals, industry, funding organizations, academia, and the legal profession.
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Dor Crônica , Síndrome Pós-Laminectomia , Dor Crônica/diagnóstico , Síndrome Pós-Laminectomia/diagnóstico , Humanos , Classificação Internacional de Doenças , Manejo da Dor , Coluna VertebralRESUMO
BACKGROUND: Central sensitization (CS) is a form of neuroplasticity characterized by changes in the neural sensitivity, responsiveness, and/or output that are not contingent on peripheral input nor activity-dependent. CS is characterized by activation of unmyelinated C-fibers resulting in a cascade of events at molecular and cellular levels which eventuate into generation of synaptic currents at rest. CS, therefore, contributes to heightened generalized pain sensitivity, further complicates the process of reaching a diagnosis, and increases the possibility of treatment failure. BODY: Trigeminal nerve is the main sensory supplier of the anterior part of the head, including the intraoral structures. Primary afferent nociceptors of the trigeminal nerve and low threshold mechanoreceptors synapse with wide dynamic range (WDR) neurons in the pons. This multifaceted network of nerve interactions which is further complicated by the modulatory circuits that can suppress or heighten the activity of WDR neurons is one of the main contributors to CS. The importance of CS in orofacial pain disorders is emphasized in the context of chronic pain development. As for all chronic pain conditions, it is crucial to consider the biopsychosocial aspects of chronic orofacial pain in managing this diverse group of conditions. This review highlights current understanding of the biopsychosocial model and central mechanisms contributing to the pathogenesis of chronic orofacial pain.
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Dor Facial , Nociceptores , Nervo Trigêmeo , Dor Facial/fisiopatologia , Dor Facial/terapia , Humanos , Estimulação Física , Nervo Trigêmeo/fisiopatologiaRESUMO
Aim: The principal study objective was to investigate the pharmacokinetic characteristics and determine the absolute bioavailability and tolerability of a new sublingual (SL) buprenorphine wafer. Methods: The study was of open label, two-way randomized crossover design in 14 fasted healthy male and female volunteers. Each participant, under naltrexone block, received either a single intravenous dose of 300 mcg of buprenorphine as a constant infusion over five minutes or a sublingual dose of 800 mcg of buprenorphine in two treatment periods separated by a seven-day washout period. Blood sampling for plasma drug assay was taken on 16 occasions throughout a 48-hour period (predose and at 10, 20, 30, and 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours postdose). The pharmacokinetic parameters were determined by noncompartmental analyses of the buprenorphine plasma concentration-time profiles. Local tolerability was assessed using modified Likert scales. Results: The absolute bioavailability of SL buprenorphine was 45.4% (95% confidence interval = 37.8-54.3%). The median times to peak plasma concentration were 10 minutes and 60 minutes after IV and SL administration, respectively. The peak plasma concentration was 2.65 ng/mL and 0.74 ng/mL after IV and SL administration, respectively. The half-lives were 9.1 hours and 11.2 hours after IV and SL administration, respectively. The wafer had very good local tolerability. Conclusions: This novel sublingual buprenorphine wafer has high bioavailability and reduced Tmax compared with other SL tablet formulations of buprenorphine. The wafer displayed very good local tolerability. The results suggest that this novel buprenorphine wafer may provide enhanced clinical utility in the management of both acute and chronic pain. Background: Buprenorphine is approved for use in pain management and opioid addiction. Sublingual administration of buprenorphine is a simple and noninvasive route of administration and has been available for many years. Improved sublingual formulations may lead to increased utilization of this useful drug for acute and chronic pain management.
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Analgésicos Opioides/uso terapêutico , Buprenorfina/farmacocinética , Buprenorfina/uso terapêutico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Administração Sublingual , Adolescente , Adulto , Analgésicos Opioides/administração & dosagem , Disponibilidade Biológica , Buprenorfina/administração & dosagem , Estudos Cross-Over , Feminino , Humanos , Masculino , Manejo da Dor/métodos , Adulto JovemRESUMO
BACKGROUND: A task force of the International Association for the Study of Pain (IASP) has developed a classification of chronic pain for the ICD-11 consisting of seven major categories. The objective was to test whether the proposed categories were exhaustive and mutually exclusive. In addition, the perceived utility of the diagnoses and the raters' subjective diagnostic certainty were to be assessed. METHODS: Five independent pain centers in three continents coded 507 consecutive patients. The raters received the definitions for the main diagnostic categories of the proposed classification and were asked to allocate diagnostic categories to each patient. In addition, they were asked to indicate how useful they judged the diagnosis to be from 0 (not at all) to 3 (completely) and how confident they were in their category allocation. RESULTS: The two largest groups of patients were coded as either chronic primary pain or chronic secondary musculoskeletal pain. Of the 507 patients coded, 3.0% had chronic pain not fitting any of the proposed categories (97% exhaustiveness), 20.1% received more than one diagnosis. After adjusting for double coding due to technical reasons, 2.0% of cases remained (98% uniqueness). The mean perceived utility was 1.9 ± 1.0, the mean diagnostic confidence was 2.0 ± 1.0. CONCLUSIONS: The categories proved exhaustive with few cases being classified as unspecified chronic pain, and they showed themselves to be mutually exclusive. The categories were regarded as useful with particularly high ratings for the newly introduced categories (chronic cancer-related pain among others). The confidence in allocating the diagnoses was good although no training regarding the ICD-11 categories had been possible at this stage of the development.
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Dor Crônica/classificação , Codificação Clínica , Classificação Internacional de Doenças , Dor Crônica/diagnóstico , Humanos , Projetos PilotoRESUMO
This guideline summary describes the fourth edition of Acute pain management: scientific evidence, which was published by the Australian and New Zealand College of Anaesthetists (ANZCA) and its Faculty of Pain Medicine (FPMANZCA) in December 2015. The fourth edition summarises the best available evidence on acute pain management, following methods established over the preceding three editions. It provides additional information by scoring the quality of and reporting further details on randomised controlled trials and meta-analyses. The information is condensed into key messages that provide: concise statements on each topic, showing the highest level of evidence; and clinical practice points based on clinical experience or expert opinion.
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Dor Aguda/terapia , Analgésicos/uso terapêutico , Medicina Baseada em Evidências , Manejo da Dor/normas , Dor Aguda/prevenção & controle , Austrália , Protocolos Clínicos/normas , Humanos , Nova Zelândia , Clínicas de Dor/organização & administração , Medição da Dor/normas , Guias de Prática Clínica como Assunto/normasRESUMO
OBJECTIVE: To quantify benefit and harm of epidural analgesia, compared with systemic opioid analgesia, in adults having surgery under general anesthesia. BACKGROUND: It remains controversial whether adding epidural analgesia to general anesthesia decreases postoperative morbidity and mortality. METHODS: We searched CENTRAL, EMBASE, PubMed, CINAHL, and BIOSIS till July 2012. We included randomized controlled trials comparing epidural analgesia (with local anesthetics, lasting for ≥ 24 hours postoperatively) with systemic analgesia in adults having surgery under general anesthesia, and reporting on mortality or any morbidity endpoint. RESULTS: A total of 125 trials (9044 patients, 4525 received epidural analgesia) were eligible. In 10 trials (2201 patients; 87 deaths), reporting on mortality as a primary or secondary endpoint, the risk of death was decreased with epidural analgesia (3.1% vs 4.9%; odds ratio, 0.60; 95% confidence interval, 0.39-0.93). Epidural analgesia significantly decreased the risk of atrial fibrillation, supraventricular tachycardia, deep vein thrombosis, respiratory depression, atelectasis, pneumonia, ileus, and postoperative nausea and vomiting, and also improved recovery of bowel function, but significantly increased the risk of arterial hypotension, pruritus, urinary retention, and motor blockade. Technical failures occurred in 6.1% of patients. CONCLUSIONS: In adults having surgery under general anesthesia, concomitant epidural analgesia reduces postoperative mortality and improves a multitude of cardiovascular, respiratory, and gastrointestinal morbidity endpoints compared with patients receiving systemic analgesia. Because adverse effects and technical failures cannot be ruled out, individual risk-benefit analyses and professional care are recommended.
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Analgesia Epidural/métodos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Saúde Global , Humanos , Morbidade/tendências , Prognóstico , Procedimentos Cirúrgicos Operatórios , Taxa de Sobrevida/tendênciasRESUMO
PURPOSE OF REVIEW: Postoperative pain remains poorly treated in many patients. One reason is the inadequate use of nonopioid analgesics. This review examines the most recent findings on nonopioid analgesics and how these translate into clinical practice. RECENT FINDINGS: Commonly used nonopioid analgesics are paracetamol, NSAIDs and metamizol (dipyrone). For paracetamol, the efficacy is obviously inferior to NSAIDs and the risk of adverse events might have been underestimated in the past. For NSAIDs, there are increasing data supporting similar efficacy of nonselective and cyclooxygenase-2 selective NSAIDs, although the adverse effects of the latter might make them the preferred option for short-term use in the perioperative setting. Metamizol (dipyrone) is a very effective nonopioid analgesic not worldwide available; the discussion on the relevance of the very rare adverse event agranulocytosis continues. SUMMARY: Nonopioid analgesics are important components of multimodal postoperative analgesia. The selection of the most appropriate compound for an individual patient can be based more and more on ever increasing data on these important analgesics.
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Analgésicos não Narcóticos/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Acetaminofen/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Dipirona/uso terapêutico , HumanosAssuntos
Analgésicos Opioides/efeitos adversos , Codeína/efeitos adversos , Medicamentos sem Prescrição/efeitos adversos , Austrália/epidemiologia , Tomada de Decisões , Overdose de Drogas/epidemiologia , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Feminino , Humanos , Masculino , Transtornos Relacionados ao Uso de Substâncias/epidemiologiaRESUMO
PURPOSE OF REVIEW: Poor pain management has continued to be a problem after pediatric surgery. This review examines the current situation and recent advances in the area. RECENT FINDINGS: Nonopioids such as paracetamol and NSAIDs play an increasing role as components of multimodal analgesia in children. However, studies on the safety and efficacy of many adjuvants in pediatrics are still lacking. The use of opioids is influenced understandably by safety concerns about respiratory depression, but data on its incidence are poor. The role of regional techniques in the treatment of pain after pediatric surgery is growing in line with the developments in adults; the emphasis here is more on peripheral techniques too. SUMMARY: The concept of multimodal analgesia including the use of regional analgesic techniques is governing the current developments and discussions in the area of pediatric postoperative analgesia.
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Dor Pós-Operatória/tratamento farmacológico , Acetaminofen/uso terapêutico , Adjuvantes Anestésicos/uso terapêutico , Analgesia , Analgésicos Opioides/uso terapêutico , Anestesia por Condução , Anti-Inflamatórios não Esteroides/uso terapêutico , Criança , Humanos , Manejo da DorRESUMO
OBJECTIVE: High levels of alcohol-related harm are a salient feature of many rural communities in Australia. General practitioners (GPs) are uniquely placed to identify and treat patients with harmful alcohol use in remote settings, yet corresponding opportunities for education in effective brief psychological interventions for harmful alcohol use are limited. This study piloted a training model for alcohol screening and brief intervention for GPs working in Kalgoorlie-Boulder, a remote Western Australian community facing significant alcohol-related problems. DESIGN: Observational pilot study. SETTING: Primary care. MAIN OUTCOME MEASURE(S): Perceived role in responding to harmful alcohol use, and confidence and knowledge of alcohol screening and brief intervention; satisfaction with a short training session focused on alcohol screening and brief intervention; and impact of training on implementation of screening and brief intervention for harmful alcohol use. RESULTS: Fifty per cent of GPs took up the training opportunity. GPs recognised their professional responsibility for conducting brief intervention but reported comparatively lower confidence and skills in implementing screening and intervention prior to training. The training improved knowledge and confidence in conducting alcohol screening and brief intervention. All GPs increased their frequency of alcohol screening, and 88% of GPs reported increasing the frequency of brief intervention at 6 months. CONCLUSIONS: Preliminary findings suggest that among participating GPs, subsequent compliance with identification and management of harmful alcohol use was improved. Further work examining methods to improve rural and remote GP participation in alcohol-related harm prevention training is required, as the potential impact on communities with disproportionately high alcohol-related difficulties is significant.
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Alcoolismo/diagnóstico , Clínicos Gerais/educação , Entrevista Motivacional/métodos , População Rural , Alcoolismo/terapia , Humanos , Projetos Piloto , Austrália OcidentalRESUMO
Despite an increasingly sophisticated understanding of pain mechanisms, acute and chronic pain remain undertreated throughout the world. This situation reflects the large gap that exists between evidence and practice in pain management and is typified by inappropriate use of nonsteroidal anti-inflammatory drugs (NSAIDs). The scientific evidence around these drugs continues to expand at a high rate, yet physicians are often unaware of best practice. To address this gap among physicians in Africa and the Middle East, an Expert Panel meeting was convened with representatives from the region. The principal objective of the meeting was to review the latest guidelines on the management of acute and chronic pain and to review the efficacy, safety, and cost-effectiveness of cyclooxygenase-2 (COX-2) inhibitors in these settings. The main outcome of this review process was a number of consensus statements concerning the definitions of acute and chronic pain, and the efficacy, safety and cost-effectiveness of traditional nonselective NSAIDs (nsNSAIDs) and selective COX-2 inhibitors (coxibs). The panel agreed that nsNSAIDs and coxibs are effective analgesics with similar efficacy for acute pain; for chronic musculoskeletal pain, NSAIDs are significantly more effective than either placebo or paracetamol. Coxibs offer important safety advantages over nsNSAIDs, including gastrointestinal safety and preservation of platelet function; notably, the cardiovascular safety of coxibs has been the subject of much recent debate. Furthermore, the panel agreed there is substantial evidence to indicate that cost savings can be achieved by using celecoxib in patients at moderate to high risk of gastrointestinal adverse events, even in countries with moderate healthcare expenditures.
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Análise Custo-Benefício , Inibidores de Ciclo-Oxigenase 2/economia , Inibidores de Ciclo-Oxigenase 2/uso terapêutico , Dor/tratamento farmacológico , Pirazóis/economia , Pirazóis/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , África , Celecoxib , Humanos , Oriente Médio , Dor/epidemiologia , Medição da DorRESUMO
OBJECTIVE: To describe the use of sublingual ketamine wafers administered by volunteer emergency medical technicians (EMTs) for pain management to patients in rural Western Australia (WA). METHODS: This retrospective cohort study included patients older than 12 years who were attended by volunteer EMTs in Esperance, Lancelin and Kalbarri, WA and received analgesic medications from 2018 to 2021. Patients who received ketamine wafers with/without other analgesics were compared to (i) patients who received only oral paracetamol and (ii) patients who received inhalational methoxyflurane without ketamine wafers with/without paracetamol. RESULTS: The present study included 826 patients, among whom 149 patients received ketamine wafer with/without other analgesics, 82 paracetamol only and 595 methoxyflurane with/without paracetamol. Patients who received ketamine wafers were younger (median age 49 years vs 54 years for the paracetamol group vs 58 years for the methoxyflurane group), required a longer median transport interval (56 min vs 20 min vs 8 min), trauma-related (73% vs 35% vs 54%), and presented higher median initial pain score (9 vs 3 vs 8 out of 10) than those who received paracetamol and those who received methoxyflurane, respectively. Eight in the ketamine wafers group (5.4%) had a record of nausea/vomiting after the administration of ketamine wafers. CONCLUSIONS: Sublingual ketamine wafer was administered by volunteer EMTs without any evidence of major adverse events in rural WA and deemed useful as an additional pain management option when long transport to hospital was needed. No other symptoms that may be associated with the use of ketamine were recorded.
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Auxiliares de Emergência , Ketamina , Humanos , Pessoa de Meia-Idade , Ketamina/efeitos adversos , Manejo da Dor , Acetaminofen/uso terapêutico , Metoxiflurano/uso terapêutico , Austrália Ocidental , Estudos Retrospectivos , Resultado do Tratamento , Analgésicos/efeitos adversosRESUMO
Perioperative lidocaine (lignocaine) infusions are being employed with increasing frequency. The determinants of systemic lidocaine concentrations during prolonged administration are unclear. In the Long-term Outcomes after Lidocaine Infusions for PostOperative Pain (LOLIPOP) pilot trial, the impact of infusion duration and body size metrics on serum lidocaine concentrations was examined with regression models in 48 women undergoing breast cancer surgery. Lidocaine was delivered as an intravenous bolus (1.5 mg/kg) and infusion (2 mg/kg per h) intraoperatively, followed by a 12-h subcutaneous infusion (1.33 mg/kg per h) postoperatively. Dosing was based on total body weight. Wound infiltration with other long-acting local anaesthetics was permitted. Protein binding and pharmacogenomic data were also collected. Lidocaine concentrations (median (interquartile range) (range)) during prolonged administration were in the safe and potentially therapeutic range: post-anaesthesia care unit 2.16 (1.73-2.82) (1.12-6.06) µg/ml; ward 1.41 (1.22-1.75) (0.64-2.81) µg/ml. Concentrations increased non-linearly during the early intravenous phase of administration (mean rise 1.21 µg/ml per hour of infusion, P = 0.007) but reached a pseudo steady-state during the later subcutaneous phase. Higher dose rates received per kilogram of lean (P = 0.004), adjusted (P = 0.006) and ideal body weight (P = 0.009) were associated with higher steady-state concentrations. The lidocaine free fraction was unaffected by the presence of ropivacaine, and phenotypes linked to slow metabolism were infrequent. Serum lidocaine concentrations reached a pseudo steady-state during a 12-h postoperative infusion. Greater precision in steady-state concentrations can be achieved by dosing on lean body weight versus adjusted or ideal body weight (equivalent lean body weight doses: intravenous bolus 2.5 mg/kg; intravenous infusion 3.33 mg/kg per h; subcutaneous infusion 2.22 mg/kg per h.
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Neoplasias da Mama , Lidocaína , Humanos , Feminino , Lidocaína/uso terapêutico , Neoplasias da Mama/cirurgia , Neoplasias da Mama/tratamento farmacológico , Anestésicos Locais/uso terapêutico , Ropivacaina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Infusões Intravenosas , Peso Corporal , Método Duplo-CegoRESUMO
AIMS: Patients with chronic health conditions not responding to conventional treatment can access medicinal cannabis (MC) prescriptions from clinicians in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, and depression in a large real-world sample of patients accessing prescribed medicinal cannabis. We hypothesized that all patient-reported outcomes (PROs) would improve from baseline to 3-months. METHODS: The QUEST Initiative is a large prospective multicenter study of patients with any chronic health condition newly prescribed medicinal cannabis between November 2020 and December 2021. Eligible patients were identified by 120 clinicians at medical centers across six Australian states. Consenting participants completed the EuroQol Group EQ-5D-5L health status questionnaire; European Organization for Research & Treatment of Cancer Quality of Life questionnaire (QLQ-C30); Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms in Fatigue and Sleep Disturbance, and the Depression Anxiety Stress Scale (DASS-21) before starting therapy, at 2-weeks titration, then monthly for 3-months. RESULTS: Of the 2762 consenting participants, 2327 completed baseline and at least one follow-up questionnaire. Ages ranged between 18-97 years (mean 51y; SD = 15.4), 62.8% were female. The most commonly treated conditions were chronic pain (n = 1598/2327; 68.7%), insomnia (n = 534/2327; 22.9%), generalized anxiety (n = 508/2327; 21.5%), and mixed anxiety and depression (n = 259/2327; 11%). Across the whole cohort both EQ-5D-5L utility scores and QLQ-C30 summary scores showed clinically meaningful improvement in HRQL from baseline to mean follow-up with d = 0.54 (95%CI:0.47 to 0.59) and d = 0.64 (95%CI:0.58 to 0.70) respectively; and clinically meaningful improvement in fatigue (d = 0.54; 95%CI:0.48 to 0.59). There was clinically meaningful reduction of pain for those with chronic pain (d = 0.65; 95%CI:0.57 to 0.72); significant improvements for those with moderate to extremely severe anxiety (X2 = 383; df = 4; p<0.001) and depression (X2 = 395; df = 4; p<0.001); and no changes in sleep disturbance. CONCLUSIONS: We observed statistically significant, clinically meaningful improvements in overall HRQL and fatigue over the first 3-months in patients with chronic health conditions accessing prescribed medical cannabis. Anxiety, depression, and pain also improved over time, particularly for those with corresponding health conditions. The study continues to follow-up patients until 12-months to determine whether improvements in PROs are maintained long-term. TRAIL REGISTRATION: Study registration - Australian New Zealand Clinical Trials Registry: ACTRN12621000063819. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000063819.
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Dor Crônica , Maconha Medicinal , Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Qualidade de Vida , Austrália/epidemiologia , Dor Crônica/tratamento farmacológico , Maconha Medicinal/uso terapêutico , Seguimentos , Estudos Prospectivos , Fadiga/tratamento farmacológicoRESUMO
OBJECTIVE: Musculoskeletal pain has been associated with N-methyl-d-aspartate (NMDA) receptor-mediated mechanisms. This randomized controlled trial (RCT) investigated the effect of the NMDA receptor antagonist ketamine (25 mg sublingually) on modulating experimental muscle pain. DESIGN: Two groups (N = 11/group) of age- and sex-matched healthy subjects performed eccentric exercise using the nondominant arm wrist extensors (time 0) to induce muscle soreness 24 hours later (time 1). INTERVENTION: Immediately prior to exercise, subjects were administered either a 25 mg ketamine lozenge or a placebo. At time 1, experimental muscle pain was augmented by injection of hypertonic saline into the extensor carpi radialis brevis (ECRB) muscle of the exercised arm. OUTCOME MEASURES: Pressure pain thresholds (PPTs), muscle soreness, muscle pain intensity (electronic visual analog scale [VAS]), and maximal wrist extension force were assessed at time 0 (pre- and postexercise) and at time 1 (pre-, during, and post saline-induced pain). RESULTS: Regardless of group, PPT was reduced at ECRB (P < 0.021) and at the common extensor origin (P < 0.034) at time 1 preinjection compared with time 0 pre-exercise. At time 1, elevated levels of muscle soreness and force attenuation were similar between groups compared with time 0 pre-exercise (P < 0.0001), and similar hypertonic saline-induced pain areas and pain intensity profiles were evident. CONCLUSION: In comparison with placebo, a single low-dose sublingual pharmacological intervention targeting the processes of sensitization via antagonism of NMDA receptors did not modulate the effects of acute experimentally induced mechanical hyperalgesia, suggesting a higher dose or repeat doses may be required.
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Analgésicos/administração & dosagem , Hiperalgesia/tratamento farmacológico , Ketamina/administração & dosagem , Administração Sublingual , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Limiar da Dor/efeitos dos fármacos , Adulto JovemRESUMO
BACKGROUND: The sublingual administration of opioids is a simple and noninvasive method that provides rapid analgesia. In this phase I study we investigated the pharmacokinetics and bioavailability of a fentanyl wafer in healthy volunteers. The principal study objective was to investigate the pharmacokinetic profile of a new sublingual fentanyl wafer and to establish its absolute bioavailability. METHODS: Twenty-four healthy volunteers, mean age 23 years, were randomly assigned to receive the equivalent of fentanyl 100 µg by both the sublingual and IV routes. Blood samples were collected in sterile polypropylene tubes for 24 hours after each fentanyl administration. The pharmacokinetic parameters were determined by model-independent pharmacokinetic analyses of the plasma fentanyl concentration-time profiles. RESULTS: The mean absolute bioavailability of the sublingual fentanyl wafer was 78.9% (90% confidence interval [CI] 51.1% to 121.7%). The first detectable plasma fentanyl concentration time ranged from 2 to 10 minutes in all volunteers, and the mean (±SD) time to peak plasma concentration at 0.91 (±0.73) hours after administration. CONCLUSION: Sublingual administration of fentanyl as a wafer product resulted in rapidly detectable plasma fentanyl concentrations. The absolute bioavailability of 78.9% indicated a high systemic availability of fentanyl and suggests that further development of this wafer is justified.
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Analgésicos Opioides/farmacocinética , Fentanila/farmacocinética , Adulto , Analgésicos Opioides/efeitos adversos , Área Sob a Curva , Disponibilidade Biológica , Estudos Cross-Over , Feminino , Fentanila/efeitos adversos , Humanos , Masculino , Adulto JovemRESUMO
OBJECTIVE: To evaluate the process and outcome of a multidisciplinary inpatient goal planning rehabilitation programme on physical, social and psychological functioning for patients with spinal cord injury. DESIGN: Clinical audit: quantitative and qualitative analyses. SETTING: Specialist spinal injury unit, Perth, Australia. SUBJECTS: Consecutive series of 100 newly injured spinal cord injury inpatients. MAIN MEASURE(S): The Needs Assessment Checklist (NAC), patient-focused goal planning questionnaire and goal planning progress form. RESULTS: The clinical audit of 100 spinal cord injured patients revealed that 547 goal planning meetings were held with 8531 goals stipulated in total. Seventy-five per cent of the goals set at the first goal planning meeting were achieved by the second meeting and the rate of goal achievements at subsequent goal planning meetings dropped to 56%. Based on quantitative analysis of physical, social and psychological functioning, the 100 spinal cord injury patients improved significantly from baseline to discharge. Furthermore, qualitative analysis revealed benefits consistently reported by spinal cord injury patients of the goal planning rehabilitation programme in improvements to their physical, social and psychological adjustment to injury. CONCLUSIONS: The findings of this clinical audit underpin the need for patient-focused goal planning rehabilitation programmes which are tailored to the individual's needs and involve a comprehensive multidisciplinary team.
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Auditoria Clínica , Avaliação de Processos e Resultados em Cuidados de Saúde , Planejamento de Assistência ao Paciente , Traumatismos da Medula Espinal/reabilitação , Atividades Cotidianas , Adaptação Psicológica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Narração , Satisfação do Paciente , Pesquisa Qualitativa , Ajustamento Social , Austrália OcidentalRESUMO
Introduction: There is a growing public health concern regarding inappropriate prescribing practices of discharge analgesia. A tertiary Australian hospital first developed its Postoperative Inpatients Discharge Analgesia Guidelines after an initial audit in 2015. Adherence to the guidelines were evaluated in 2016 and 2017 which show reduced compliance from 93.5% in 2016 to 83.4% in 2017. Aim: To assess ongoing compliance with the guidelines five years following its implementation and to evaluate patient outcome in terms of its clinical impact and minimization of harmful events. Methods: Prescribing data were obtained for discharge analgesic medication for 200 surgical patients from August 2019 to April 2020. Records were assessed against the hospital's Postoperative Inpatients Discharge Analgesia Guidelines and compared with equivalent data from the previous 2015, 2016, and 2017 audits. Patients were interviewed by telephone two weeks after hospital discharge. Results: Prescribing of analgesia was most compliant with overall guidelines for paracetamol (100% unchanged from 2017), followed by celecoxib (98%, up from 96% in 2017), tramadol IR (89% up from 74% in 2017), and pregabalin (89% up from 50% in 2017). Two weeks after discharge, 112 (56%) patients were surveyed and reported a mean pain-score of 2 (95% CI 1.5-2.5) out of 10 at that time. Thirty-two (29%) patients interviewed were still taking pain medication, with 17 (53%) taking medication supplied from the hospital. Seventy-eight (88%) patients stored their pain medication in an unlocked location. Among those no longer taking analgesia, 28 (43%) had unused pain medications, and only two (6%) had returned these to a community pharmacist. Conclusion: This study found that compliance with hospital discharge analgesia prescribing guidelines has increased, although there is room for improvement. Follow-up of the participants reveals high rates of unused opioids, improper storage and disposal of their pain medication.