Luca Miceli

Evaluation of new laryngoscope blade for tracheal intubation, Truview EVO2: a manikin study.

Background and objective Difficult airways present a clinical challenge for anaesthetists. The Truphatek Truview EVO2©; (Truphatek International Ltd, Netanya, Israel) is a new laryngoscope blade used for endotracheal intubation that could be used where there is difficulty in visualizing the laryngeal inlet. Methods Twenty anaesthetists (12 trainees and eight consultants) compared the Truphatek Truview EVO2©; with a conventional Macintosh size 3 blade. The Trucorp Airsim Bronchi©; (Trucorp Ltd, Belfast, Northern Ireland, UK) manikin was intubated under normal conditions and under simulated difficult conditions such as tongue inflation and neck rigidity. In each scenario, the Cormack–Lehane grade, time needed for successful intubation, perceived difficulty of tracheal intubation and personal preference of blade were compared. The results were analysed with t‐test (time of intubation), Wilcoxon signed‐rank sum (Cormack–Lehane grade, ease of manoeuvre, preferred blade) and analysis of variance with Bonferroni correction (augmentation of difficulties in different scenarios). Results The Truview EVO2 blade allowed the best laryngeal view as judged by the Cormack–Lehane grade (P < 0.05) in two separate situations: under simulated tongue inflation and under simulated neck rigidity. However, this blade did not reduce the intubation time or the ease of tracheal tube placement with respect to conventional Macintosh blade. Conclusion Compared with the classical Macintosh blade, the Truview EVO2 blade allowed a better view of the larynx, but did not facilitate endotracheal intubation in any of the difficult scenarios created with the adjustable manikin and in most scenarios in fact prolonged the intubation time.

Impact of potential inappropriate NSAIDs use in chronic pain

Pain remains one of the main reasons for medical consultation worldwide: moderate- to severe-intensity pain occurs in 19% of adult Europeans, seriously affecting the quality of their social and working lives. Nonsteroidal anti-inflammatory drugs (NSAIDs) are not recommended for long-term use and a careful surveillance to monitor for toxicity and efficacy is critical. This study aims to assess: 1) the pattern of use of NSAIDs and opioids in a population covered by a cloud-based pharmacovigilance surveillance system; and 2) potential inappropriate use. A retrospective 18-months systematic analysis on patients’ pain treatment was performed. The primary endpoint was evaluating the prevalence of NSAIDs and opioids use and the duration of therapy regimen. The secondary endpoint was to investigate the prevalence of NSAIDs taken for >21 consecutive days concomitant with drugs for peptic ulcer and gastroesophageal reflux disease (GORD) or antiplatelet drugs. The yearly cost for individual users of concomitant NSAIDs for more than 21 consecutive days and of GORD medications has been estimated. A total of 3,050 subjects with chronic pain were enrolled; 97% of them took NSAIDs for >21 consecutive days; about one-fourth of these users also received drugs for peptic ulcer and GORD (Anatomical Therapeutic Chemical code A02B). The yearly cost foran individual who uses NSAIDs for >21 consecutive days as well as concomitant GORD medications is 61.23 euros. In total, 238 subjects (8%) using NSAIDs for >21 days also received one antiplatelet agent. About 11% of subjects received opioids at least once and only 2% of them carried on the therapy for more than 90 consecutive days. In evaluating the escalation in dosage as a proxy of dependence risk, this study shows no dosage escalation in our cohort of chronic pain population - that is to say we show no risk of dependence.

Opioids and Driving Ability: Current Data do not Support One Opioid Being More Favorable Than Another

To the Editor: Miceli et al. conclude from the reaction time measurements taken on a single subject that tramadol and oxycodone/naloxone differ in their propensity to cause car accidents. This conclusion is not supported by the evidence presented. Repeated measurement procedures can provide valid statistical results with a limited number of subjects, but the statistical assumptions underlying the model cannot be validated with only one subject. Also, the single patient conclusion cannot control for potential predictive and prognostic factors that could have influenced the result. Indeed, differences in the testing results could be explained by many factors, not only the difference in drug treatment. One explanation could be a training effect (commonly termed a period effect) producing faster reaction times at the second study session. Any of the factors that influence reaction time (e.g. sleepiness, distraction) could also have had greater or lesser effects on different study days. Furthermore, the difference could only be detected after additional statistical testing. It is significant that the results obtained with both drugs “would allow the subject to drive vehicles...”, so the postulated statistical difference had no clinical implication. Of particular importance, the International Council on Alcohol, Drugs, and Traffic Safety recommendations state that a test battery to measure driver fitness should include divided attention, motor response, sustained attention (vigilance), and accuracy of decisionmaking, among other parameters. Simple tests measuring only visual and auditory reaction times fail to provide deeper insight into the complexity of driving a vehicle. The current ICADT classification of psychoactive medication is not based on the proposed test battery and should therefore be interpreted with caution. There are study data demonstrating that tramadol/paracetamol has less impact on vigilance (choice reaction time, somnolence) than codeine/paracetamol. Jamison et al. found no differences between transdermal fentanyl and oxycodone/acetaminophen in their effect on neuropsychological performance, and a series of studies using identical methodology demonstrated that the performance of chronic pain patients receiving transdermal buprenorphine, fentanyl, or sustained-release oxycodone did not differ significantly from an ageindependent control group. In a recent study, patients treated with sustained-release or transdermal opioids (morphine, fentanyl, oxycodone, hydromorphone, buprenorphine) performed an on-the-road driving test. No difference was found in the primary outcome parameter – standard deviation of lateral position (SDLP) – between patients and healthy controls. There is currently no gold standard for assessing driving ability while receiving opioids, and available data do not support the conclusion that one opioid is more favorable than others. Systematic reviews of published data on driving ability and opioids found high between-subject variability, and that study results may be influenced by many factors. These include trial methodology, patient selection, and confounding factors such as pain severity, co-medication, sleep disturbance and fatigue, and comorbid psychiatric and psychological disorders. In line with these results, the summaries of product characteristics of opioids such as oxycodone and tramadol similarly indicate that driving ability maybe impaired. Owing to the individual variability of response and the impact of other factors (e.g., pain intensity, co-morbidity), recommendations on whether or not to drive should be made on an individual basis.

Low-back pain at the emergency department: still not being managed?

Background Low-back pain (LBP) affects about 40% of people at some point in their lives. In the presence of “red flags”, further tests must be done to rule out underlying problems; however, biomedical imaging is currently overused. LBP involves large in-hospital and out-of-hospital economic costs, and it is also the most common musculoskeletal disorder seen in emergency departments (EDs). Patients and methods This retrospective observational study enrolled 1,298 patients admitted to the ED, including all International Classification of Diseases 10 diagnosis codes for sciatica, lumbosciatica, and lumbago. We collected patients’ demographic data, medical history, lab workup and imaging performed at the ED, drugs administered at the ED, ED length of stay (LOS), numeric rating scale pain score, admission to ward, and ward LOS data. Thereafter, we performed a cost analysis. Results Mean numeric rating scale scores were higher than 7/10. Home medication consisted of no drug consumption in up to 90% of patients. Oxycodone–naloxone was the strong opioid most frequently prescribed for the home. Once at the ED, nonsteroidal anti-inflammatory drugs and opiates were administered to up to 72% and 42% of patients, respectively. Imaging was performed in up to 56% of patients. Mean ED LOS was 4 hours, 14 minutes. A total of 43 patients were admitted to a ward. The expense for each non-ward-admitted patient was approximately €200 in the ED, while the mean expense for ward-admitted patients was €9,500, with a mean LOS of 15 days. Conclusion There is not yet a defined therapeutic care process for the patient with LBP with clear criteria for an ED visit. It is to this end that we need a clinical pathway for the prehospital management of LBP syndrome and consequently for an in-hospital time-saving therapeutic approach to the patient.

Alcohol, Pain, and Opioids: Which Is a Major Threat to Driving Ability?

TO THE EDITOR: In a recent review of medications and impaired driving, the authors concluded that it was difficult to determine if impaired driving performance was a result of psychotropic medication or the underlying condition. Opioids are associated with sedation and dizziness, and there are concerns regarding their impact on driving; however, data suggest that strong opioids do not necessarily impair and may even improve psychomotor, cognitive functioning, and driving ability in patients with chronic noncancer pain. Italian law prohibits driving while taking psychoactive substances, including opioids, if it causes psychophysical disturbances (Italian Highway Code, Rule 187); however, roadside assessment is impractical. For driving under the influence of alcohol, no evaluation of psychophysical status is required; blood alcohol levels >0.5 g/L lead to driving license withdrawal (Italian Highway Code, Rule 186). We report our data from a recent study investigating the effects of opioids on psychomotor performance in patients with chronic pain and a comparison with volunteers before and after alcohol consumption. After approval from our local ethics committee, we compared psychomotor effects in healthy volunteers before and after “legal” alcohol exposure (<0.5 g/L) and oral fixed-dose prolonged release oxycodone-naloxone (OXN), an opioid agonist-antagonist combination effective for pain treatment with fewer gastrointestinal side effects versus other strong opioids, in patients with chronic pain. We performed noninvasive simple and complex visual and auditory reflex assessments in 35 volunteers (mean age = 36.8 ± 7.9 years) and in 10 patients (mean age = 62.2 ± 7.3 years) with severe chronic nonmalignant pain (Numerical Rating Scale >6) taking no psychotropic drugs and with preserved mental status (Mini Mental Status Examination score >26). Patients were assessed at baseline, at 1 week after starting oral OXN 10 mg twice daily, and after 2 weeks, when the stable OXN regimen had achieved good pain relief (Numerical Rating Scale ≤3). After alcohol consumption, 25/35 healthy volunteers had blood alcohol <0.5 g/L. Baseline reaction performance (Table 1) was worse in patients than in healthy volunteers (P < 0.01). In patients, performance did not change substantially after 1and 2-week OXN exposure. In volunteers, performance was significantly impaired with alcohol <0.5 g/L (P < 0.001). Linear regression analysis found significant but modest correlations between alcohol levels and changes in visual and auditory reflexes (P < 0.05 for all), but changes from baseline were similar in those with blood alcohol less than or greater than 0.5 g/L. The percentage decrease in visual and auditory performance after alcohol exposure is consistent with that reported by other investigators. Baseline values in patients were significantly worse than in healthy volunteers, in accordance with literature suggesting that pain negatively affects visual and auditory performance. Our data support those from previous studies, suggesting that, unlike healthy volunteers exposed to legal alcohol doses, psychomotor functioning, crucial for safe driving, is not impaired in patients receiving effective pain relief with OXN therapy. Reliable objective noninvasive tools that assess visual and auditory reflexes are now available for mobile devices for simple roadside evaluation of psychomotor and cognitive functioning of drivers with chronic pain treated with opioids. 546185 AOPXXX10.1177/1060028014546185Annals of PharmacotherapyMiceli et al research-article2014

Development of a test for recording both visual and auditory reaction times, potentially useful for future studies in patients on opioids therapy

OBJECTIVE Italian Road Law limits driving while undergoing treatment with certain kinds of medication. Here, we report the results of a test, run as a smartphone application (app), assessing auditory and visual reflexes in a sample of 300 drivers. The scope of the test is to provide both the police force and medication-taking drivers with a tool that can evaluate the individuals capacity to drive safely. METHODS The test is run as an app for Apple iOS and Android mobile operating systems and facilitates four different reaction times to be assessed: simple visual and auditory reaction times and complex visual and auditory reaction times. Reference deciles were created for the test results obtained from a sample of 300 Italian subjects. Results lying within the first three deciles were considered as incompatible with safe driving capabilities. RESULTS Performance is both age-related (r>0.5) and sex-related (female reaction times were significantly slower than those recorded for male subjects, P<0.05). Only 21% of the subjects were able to perform all four tests correctly. CONCLUSION We developed and fine-tuned a test called Safedrive that measures visual and auditory reaction times through a smartphone mobile device; the scope of the test is two-fold: to provide a clinical tool for the assessment of the driving capacity of individuals taking pain relief medication; to promote the sense of social responsibility in drivers who are on medication and provide these individuals with a means of testing their own capacity to drive safely.

Use of Opioids for Pain Relief While Driving: When The Patient Meets The Police

To the Editor: The Italian Highway Code does not have an agreement with the scientific evidence when prescribing opioids in pain therapy. This leads to considerable legal implications in the clinical practice as described in the following case. A Caucasian 69-year-old male patient suffering from bilateral lower back, and leg pain was being treated with slow release tramadol (Unitrama 200 mg orally once daily). The patient reported acceptable pain relief (numerical rating scale [NRS] 3) as well as notable constipation, dizziness and drowsiness, in particular while driving. This patient was subsequently diagnosed for a suspected hernia recurrence, and epidural infiltrations were hence planned to commence within 30 days. The Italian Highway Code forbids driving while under the influence of psychotropic substances (http://www.aci.it/?id=742) (as listed in a specific table published by Ministry of Health [http:// www.salute.gov.it/medicinaliSostanze/paginaInternaMedicinaliSostanze.jsp?id=7&menu=strumenti]) which may cause contextual impairment of psychophysical status. The list includes all opioids with the exception of tramadol, which was excluded in 2006 (Decreto ministeriale 19 giugno 2006, Gazzetta Ufficiale Repubblica Italiana n.147, 27-6-2006, pag 59). Tramadol can thus be used to treat chronic pain and permit patients to drive, even in the case of altered psychophysical status. The first goal is to reduce the patient’s side effects, while preserving adequate analgesia until epidural infiltrations could be administered. We replaced slow release tramadol 200 mg/die (Unitrama ) with a combination of naloxone/oxycodone (Targin 5 mg bis in die –BID-), obtaining adequate pain control (NRS 2) and a reduction in constipation, dizziness, and drowsiness. The second goal was to investigate the patient’s psychophysical status. To do this in an objective way, we used the TR 2000 Reflex Tester (Sodi Scientifica, Caledon, FI, Italy) to evaluate the patient’s visual and auditory reaction times (we chose this instrument because it is presently used in Italy in aptitude tests, as stipulated by the Italian Highway Code (http://www.aci.it/sezione-istituzionale/al-servizio-del-cittadino/codicedella-strada/titolo-iv-guida-dei-veicoli-e-conduzione-degli-animali/ art-119-requisiti-fisici-e-psichici-per-il-conseguimento-della-patente-diguida.html), for driving licenses for vehicles exceeding 3500 Kg; successful performance is considered for results exceeding the 4th decile of reference population). Following several days of therapy with slow release tramadol alone and then following treatment with naloxone/oxycodone association, the patient’s visual and auditory reflexes were assessed in a series of 30 repeated measures, and the results are recorded. An average visual reaction time of 204 ms (SD 31 milliseconds) was detected with slow release tramadol and 194 milliseconds (SD 34 milliseconds) with naloxone/oxycodone, while an auditory reaction time of 188 milliseconds (SD 27 milliseconds) was associated with slow release tramadol and 161 milliseconds (SD 29 milliseconds) with naloxone/oxycodone. In both cases, the results would allow the subject to drive vehicles exceeding 3500 kg in accordance with the Italian highway code (art. 119). Using a two-tailed t test for paired samples, auditory responsiveness was greater when the patient was treated naloxone/oxycodone than when he was treated with tramadol, (P < 0.0002-Graphpad Instat version 5.0). This result is consistent with other data, which indicate tramadol to be less safe for driving than oxycodone (as assessed using the “on the road driving test”; a test used by the company ICADTS that shows tramadol to impair driving performance to a great extent than oxycodone). These results lead us to ask the question: What is the better? Prescribing a painkiller that is permitted by law but that increases the likelihood of a car crash or a drug that could reduce the likelihood of causing a car crash itself? Is this problem limited to Italy or is it a more widespread issue?

Can a Smartphone Application Help Balance Patient Autonomy and Public Safety in Drivers Who Take Psychoactive Medications

Dear Editor, Driving under the influence of drugs (DUID) is a known phenomenon that has been well explored from clinical, social, and legal viewpoints [1]. Despite the recognition of this problem, there is no objective impairment evaluation tool available for patients on psychotropic drug therapy, health care professional, or police for psychomotor drugs other than alcohol. Police in many countries sanction drivers for DUID on the basis of subjective suspicion of impairment. In a minority of countries, such as the United States and the United Kingdom, the …

Development of an APP Helpful to Manage Patients with Low Back Pain.

To the Editor: The e-health in pain medicine is an increasing reality, with a lot of APP beside conventional websites. Unfortunately, often the software is developed without aid of specific clinical expertise. The focus on low back pain (LBP) is due to his prevalence between general practitioners (GP), showed in a recent review that denotes that 26% of Italian people suffers of chronic pain and the back was involved in 42%; 43% of patients was sent to specialist for his problem, and 31% of patients took no painkillers medication. A recent analysis sponsored by Italian Ministry of Health shows how 50% of patients that reaching pain specialist do not have a GP screening visit, and 17% come resubmitted to GP (http://www.viveresenzadolore.it/ wp-content/uploads/2013/09/LinkUp_presentazione.pdf). A recent effort to frame the patient flow from and to GP and pain specialist evaluates the presence or absence of neuropathic component in LBP, suspects of red flags as cauda equina syndrome or fracture, level of patient pain, and disability. On this basis, the local medical task force (comprehending emergency room doctor, orthopedic, GP, pain therapist, physiatrist, and epidemiologist) creates an algorithm to manage the patient flow fromGP and pain specialist, comprehensive of waiting list considerations. The final flowchart provided a GP evaluation in case of LBP and initial pharmacological treatment (opioids are indicated when pain measured with a numeric rating scale —NRS->4). In case of NRS≥4 over 2 weeks a second GP evaluation is required, including patient disability (modified activity daily living score ADL): If ADL score is ≥4/6, the patient will be scheduled for specialist visit within 10 days (B priority) in case of mild pain (4<NRS<6), 24 hours (U priority) in case of NRS>6; if the ADL score is < 3/6, the patient will be scheduled for specialist evaluation within 60 days (D priority) in case of mild pain, within 10 days in case of high pain. GP will also perform the douleur neuropathique 4 score (DN 4) on his patient with the purpose of sending the patient to anesthetist specialist or neurologist in case of score ≥ 4/10. Finally, in case of suspected cauda equina syndrome and or fracture, the specialist visit will be performed within 24 hours. To make this clinical algorithm as simple as possible, we developed software (free web platform on web address: www.minosse.biz and APP for iOS© and Android© portable devices on specific on line stores, see Figure 1) that, in simple, easy, and quick manner, aid the doctor to perform the above-described evaluations. The decisional tree build only via numerical options (page by page GP is accompanied along various scores until the final decision to send or not the patient to specialist and with which timing) and the registration option offered by the software make this tool useful for scientific proposal too, to increase the appropriateness and homogeneity in LBP treatment: The anonymous collected data after the medical registration can so contribute to create a shared pathways on LBP.

Tracheal intubation using a classic laryngeal mask airway, frova introducer, and pediatric bronchoscope

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