Continuous Ambulatory Delivery Device Use for Patients Managed by an Inpatient Palliative Care Team.

BACKGROUND: The use of Patient Controlled Analgesia (PCA) via a Continuous Ambulatory Delivery Device (CADD) is a common and effective means of pain and symptom management for hospitalized patients with a malignancy. Studies exploring the indications for starting such a device for hospitalized inpatients referred to inpatient palliative care teams are limited. AIM: This retrospective chart review aims to explore indications, timing of initiation, and barriers to the use of a CADD. METHODS: Over a six month period, during daily inpatient palliative care consult team rounds, patients who required a CADD were enrolled in this study. Sixty-one adult patients were identified who required a pump for symptom control. The team's database sheets were used to capture patient demographics. RESULTS: The main reasons for initiating a Continuous Ambulatory Delivery Device in the above setting included: lack of efficacy of oral opioids and to increase patient autonomy of their pain management. Approximately 20% of patients required transfer to another unit that could accommodate the CADD. The median length of stay for these patients was 13 days, with a median length of half a day for a pump to be started. CONCLUSIONS: This initial study provides the Palliative Care Consult Team with information on the indications for the use of a CADD. The lack of universal access to a CADD in various areas of our hospital due to differences in departmental protocols may compromise good symptom management and patient safety. These results strengthen the argument that the existing hospital policy requires revamping to improve CADD access. A CADD has been shown to provide hospitalized patients, with a malignancy, with timely access to effective symptom management, and in turn, reducing their length of stay in hospital. These findings will help inform this organization's CADD policy and support the need to broaden access to this device.

Patient-Controlled Analgesia (PCA): Intravenous Administration (IV-PCA) versus Oral Administration (Oral-PCA) by Using a Novel Device (PCoA® Acute) for Hospitalized Patients with Acute Postoperative Pain-A Comparative Retrospective Study.

Background: Acute postoperative pain delays recovery and increases morbidity and mortality. Opioid therapy is effective but is accompanied by adverse reactions. Patient-controlled analgesia (PCA) enables self-administration of analgesics. Oral-PCA is a safe and beneficial alternative to intravenous (IV) PCA. We have developed a novel Oral-PCA device, which enables self-administration of solid pills to the patient's mouth. This is a retrospective study comparing the effectiveness and usability of this novel Oral-PCA with those of IV-PCA. Methods: Medical records of patients who received PCA following gynecology and orthopedic surgeries were analyzed. The control cohort (n = 61) received oxycodone by IV-PCA. The test cohort (n = 44) received oxycodone by Oral-PCA via the PCoA Acute device. Outcome measures include the Numeric Rating Scale (NRS) score at rest and movement, side effects, technical difficulties, bolus dose administered, and bolus dose requested. Results: Patient demographics, initial NRS, and PCA duration were comparable between cohorts. NRS reduction in rest and movement was stronger in the Oral-PCA cohort (rest: 1.61 and 2.27, P = 0.077; movement: 2.05 and 2.84, P = 0.039), indicating better pain control and mobility for Oral-PCA. Side effect rates were comparable between cohorts (9% and 11% of patients who experienced side effects, P = 1.000). The rate of technological difficulties was higher in the Oral-PCoA cohort (19.7% and 36.4%, P = 0.056). The mean total bolus dose administered to patients was comparable in both cohorts (18.32 mg and 21.14 mg oxycodone, P = 0.270). However, the mean total boluses requested by patients during lockout intervals were lower in the Oral-PCA cohort (12.8 mg and 6.82 mg oxycodone, P = 0.004), indicating better pain control. Conclusions: Oral-PCA by using PCoA® Acute provides pain control and usability which is noninferior to the IV-PCA, as well as superior to pain reduction in rest and movement. These results, along with the noninvasiveness, medication flexibility, and reduced cost, suggest the potential of Oral-PCA, by using PCoA Acute, to replace IV-PCA for postoperative analgesia.

Sufentanil Sublingual Tablet System: from rationale of use to clinical practice.

The control of post-operative pain in Italy and other western countries is still suboptimal. In recent years, the Sufentanil Sublingual Tablet System (SSTS; Zalviso; AcelRx Pharmaceuticals, Redwood City, CA, USA), which is designed for patient-controlled analgesia (PCA), has entered clinical practice. SSTS enables patients to manage moderate-to-severe acute pain during the first 72 postoperative hours directly in the hospital setting. However, the role of SSTS within the current framework of options for the management of post-operative pain needs to be better established. This paper presents the position on the use of SSTS of a multidisciplinary group of Italian Experts and provides protocols for the use of this device.

Comparative study of different epidural infusion sets at maximum speeds for labor analgesia. / Estudio comparativo de diferentes sets de infusión epidural a velocidades máximas para analgesia del parto.

INTRODUCTION: The higher injection pressure obtained with epidural boluses give greater anaesthetic spread, and therefore better sensory block. Therefore, it stands to reason that anaesthetic administered at greater injection pressure and a higher flow rate would spread to a higher sensory level. OBJECTIVE: Our aim was to compare the sensory level reached with the high flow. and standard flow set at maximum rates. MATERIAL AND METHODS: We included 73 primiparous women who requested epidural analgesia for labour using programmed intermittent epidural boluses of 0.1% ropivacaine at a flow rate of 10ml/h and 2 ug/ml fentanyl plus patient-controlled epidural analgesia. The boluses were administered with a standard (250ml/h) or high-flow (500ml/h) infusion set, according to the usual clinical practice of each anaesthesiologist. The primary objective was to evaluate the sensory level reached. Secondary objectives were pain on a visual analogue scale, motor block measured on the modified Bromage scale, and anaesthesia consumption in terms of rescue analgesia (patient-controlled epidural analgesia) and anaesthesiologist-administered boluses. RESULTS: The median maximum sensory level reached was T9 in the high flow group and T7 in the standard flow group; this difference was statistically significant (p=.0002). There were no significant differences in visual analogue scale, Bromage or rescue analgesia between groups. CONCLUSION: Our results show that the high flow set does not offer benefits. The use of such sets need to be evaluated due to their higher cost.

CE: Original Research: Errors in Postoperative Administration of Intravenous Patient-Controlled Analgesia: A Retrospective Study.

: Background: Intravenous patient-controlled analgesia (IV PCA), which typically involves opioids, has become widely used in clinical settings as an effective method of pain management. Identifying errors in the administration of these drugs is essential to improving patient outcomes. This study sought to describe and analyze the errors associated with postoperative IV PCA. METHODS: Relevant data were collected from the medical records of all patients who received IV PCA at a large academic medical center in South Korea during a three-year period. The study sample comprised 45,104 patients who used one of four types of IV PCA delivery devices. RESULTS: Errors occurred in 406 cases (0.9%). Operator error was the most common type of error (54.7%), followed by device malfunction (32.3%), prescription error (12.3%), and patient error (0.7%). Of the 222 operator errors, the most frequent type was failure to begin IV PCA drug administration (28.8%), followed by programming errors by non-anesthesia providers who weren't authorized to program the device (24.8%) and wrong infusion rates set by anesthesia providers who were so authorized (24.8%). CONCLUSIONS: The findings provide valuable information that can aid in the development of policy and procedures for safer, more effective postoperative administration of IV PCA. They also suggest that it's necessary not only to improve the operation of acute pain services teams, but also to ensure ongoing provider and patient education specific to IV PCA use.

The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

BACKGROUND: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system. METHODS: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016. RESULTS: Of 1,430 IV-PCA events reported during the study period, 6.4% were adverse events (AEs) as identified via structured data fields in the MEDWATCH forms. Upon qualitative review of the narrative texts, 11.0% of events were associated with an unfavorable clinical outcome, which was 71% higher than the incidence of the adverse outcomes reported using the structured data fields. Device-related issues, which were mostly preventable, accounted for 86.9% of events. Of 65 reportable events submitted by manufacturers, 18.5% did not comply with reporting requirements as mandated by law. CONCLUSION: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.

Repetitive on-demand drug release from polymeric matrices containing a macroscopic spherical iron core.

A system for multiple on-demand drug release has been prepared that can be activated with an alternating magnetic field as external trigger. The core/shell samples have been developed based on a macroscopic spherical iron core coated with a thermoresponsive polymer, poly(styrene-stat-butyl methacrylate), containing ibuprofen as a model drug. During exposure of the samples to the magnetic field (ON state), the release rate of ibuprofen is significantly increased, up to 35 times the release rate without the magnetic field (OFF state). Using one sample or two samples in line with the magnetic field does not influence the ON/OFF ratio of the system, showing the possibility of using multiple samples to increase and tune the drug dose. Increasing the concentration of ibuprofen in the polymer layer is shown to increase the release rate in both the ON and OFF states. Increasing the size of the iron core and, consequently, decreasing the polymer thickness, was found to only increase the release rate during exposure resulting in higher ON/OFF ratios. The developed on demand drug delivery systems represents a promising development towards on demand drug delivery implants. REFLECTIONS ON CAREER GOALS: During my chemical engineering studies, it was only during my master thesis work that I decided to continue with PhD research as I really enjoyed doing original research. When coming to the end of my PhD research under supervision of Prof. Ulrich S. Schubert, I developed the ambition to pursue an academic career. Fortunately, I got the opportunity to stay with Prof. Schubert as project leader for the Dutch Polymer Institute (DPI). Within this position, I supervised ten researchers and was able to start developing my independent research lines. Despite that I now advise students to not stay in the same laboratory, this first position allowed me to gain some initial independence and to publish a large number of papers that has been a great benefit in my further career. After two and a half years I needed a new challenge that I found by taking up a part-time position at a start-up company in Eindhoven, Dolphys Medical BV, while I also continued as part-time group leader for the DPI. As senior product developer, I was in charge of the research and learned to focus on the application rather than scientific curiosity. This experience made me realize that I prefer the freedom to do academic blue sky research and decided to fully go for an academic position. After personal discussions with some prominent professors in the Netherlands, I applied for a postdoc fellowship in the Netherlands with Prof. Roeland Nolte as well as a Humboldt fellowship in Germany with Prof. Martin Möller, which I both got. As a result, I went one year 'abroad' to Aachen and returned to Nijmegen where I intended to start my independent career. However, another opportunity came along. Via my personal network I was informed that I would make a good chance if I applied for a new professor scheme in Ghent. So I applied and the rest is history. Picture of the Supramolecular Chemistry Group (2017).

Programmed intermittent peripheral nerve local anesthetic bolus compared with continuous infusions for postoperative analgesia: A systematic review and meta-analysis.

STUDY OBJECTIVE AND BACKGROUND: The role of the programmed intermittent bolus (PIB) technique for infusion of local anesthetics in continuous peripheral nerve blockade (CPNB) remains to be elucidated. Randomized controlled trials (RCTs) on PIB versus continuous infusion for CPNB have demonstrated conflicting results and no systematic review or meta-analysis currently exists. We aimed to delineate via systematic review with meta-analysis if there is any analgesic benefit to performing PIB versus continuous infusion for CPNB. DESIGN: We conducted a systematic review and random-effects meta-analysis of RCTs. DATA SOURCES: We searched Medline, Embase, and the Cochrane Library without language restriction from inception to 2-May-2017. ELIGIBILITY CRITERIA: Included RCTs had to compare PIB to continuous infusion in adult surgical patients receiving any upper or lower limb CPNB for postoperative analgesia. VAS pain scores were the primary outcome. The Cochrane Risk of Bias Tool with GRADE methodology was utilized to assess evidence quality. RESULTS: Nine RCTs (448 patients) met the inclusion criteria. Two studies performed upper limb blocks and the rest lower limb blocks. Five RCTs activated the CPNB with long-acting local anesthetic and only five used multi-modal analgesia. PIB modestly reduced VAS pain scores at 6h (-14.2mm; 95%CI -23.5mm to -5.0mm; I2=82.5%; p=0.003) and 12h (-9.9mm; 95%CI -14.4mm to -5.4mm; I2=12.4%; p<0.001), but not at later time points. There were no other meaningful differences in the rest of the outcomes, apart from more residual motor block with PIB (OR 4.27; 95% CI 1.08-16.9; p=0.04; NNTH=8). GRADE scoring ranged from low to very low. CONCLUSIONS: The existing evidence demonstrates that PIB does not meaningfully reduce VAS pain scores in CPNB. This systematic review provides important information about the limitations of existing studies. Future studies should reflect contemporary practice and focus on more painful operations.

Comparative Safety of Morphine Delivered via Intravenous Route vs. Patient-Controlled Analgesia Device for Pediatric Inpatients.

CONTEXT: Although patient-controlled analgesia (PCA) is an effective pain control modality, there is a lack of large studies on PCA safety in pediatric patients. OBJECTIVES: This study compared the delivery of morphine either via intravenous route (morphine IV) or via PCA device (morphine PCA) on risk of cardiopulmonary resuscitation (CPR) and mechanical ventilation (MV) using a large administrative database. METHODS: We assembled a retrospective cohort of pediatric inpatients between five and 21 years old in 42 children's hospitals between 2007 and 2011 from the Pediatric Health Information System database. After propensity score matching, we created matched cohorts of morphine PCA and morphine IV patients, in both surgical and nonsurgical samples, who were similar on demographic, clinical, and hospital-level factors. We examined if PCA administration was associated with greater likelihood of CPR or MV up to two days after drug administration. RESULTS: Surgical and nonsurgical patients administered morphine PCA generally had lower odds of having MV on the baseline day and up to two days after PCA exposure, although these estimates were not statistically significant. Similarly, PCA exposure was associated with about 20%-44% lower odds of same day CPR in both surgical and nonsurgical patients, with a slightly greater reduction in the odds of CPR in the surgical patients. CONCLUSION: In this large pediatric inpatient population, morphine administered via PCA device for surgical and nonsurgical pain was not associated with an increased risk of receiving CPR or MV, and was associated with slightly better safety outcomes than intravenous morphine.

Capturing Essential Information to Achieve Safe Interoperability.

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

Patient-Controlled Fentanyl Iontophoretic Transdermal System Improved Postoperative Mobility Compared to Intravenous Patient-Controlled Analgesia Morphine: A Pooled Analysis of Randomized, Controlled Trials.

BACKGROUND: Postoperative pain management protocols that use patient-controlled analgesia (PCA) can hinder mobility due to attached machinery and tubing. Immobility in the postoperative setting can increase complications, length of stay (LOS), and costs. Early and enhanced mobilization can reduce the cost of care while improving patient outcomes. A needle-free, compact, patient-activated, and portable fentanyl iontophoretic transdermal system (fentanyl ITS, IONSYS; The Medicines Company, Parsippany NJ) has been shown to provide comparable efficacy and tolerability to intravenous (IV) PCA morphine that promotes improved mobility. METHODS: This pooled analysis of 1,882 patients across three randomized, controlled trials compared fentanyl ITS to IV PCA morphine for postoperative pain management. Outcomes of patient mobility were assessed by a validated Patient Ease of Care Questionnaire that was given to patients, patients' nurses, and physical therapists involved in patient care. Safety was assessed via spontaneously reported treatment-emergent adverse events (TEAE). RESULTS: Fentanyl ITS significantly improved overall patient mobility, each mobility subscore (P < 0.0001) across all demographics (male/female; elderly/non-elderly; normal BMI/overweight/obese/morbidly obese) and surgery types, and was consistent across nurses and physical therapists mobility assessments. TEAEs were generally similar between the two groups. However, more patients reported an opioid-related TEAE with morphine IV PCA than with fentanyl IV PCA (P = 0.003). CONCLUSION: Due to improved mobility with fentanyl ITS, complications are expected to be less frequent than with IV PCA and epidural PCA. Incorporation of this strategy into postoperative pain management protocols may reduce LOS and total hospital costs.

A Patient-Controlled Analgesia Adaptor to Mitigate Postsurgical Pain for Combat Casualties With Multiple Limb Amputation: A Case Series.

The use of explosive armaments during Operation Iraqi Freedom, Operation Enduring Freedom, and Operation New Dawn has resulted in a significant number of injured U.S. service members. These weapons often generate substantial extremity trauma requiring multiple surgical procedures to preserve life, limb, and restore function. For those individuals who require multiple surgeries, the use of patient-controlled analgesia (PCA) devices can be an effective way to achieve adequate pain management and promote successful rehabilitation and recovery during inpatient treatment. A subpopulation of patients are unable to independently control a PCA device because of severe multiple limb dysfunction and/or loss. In response to the needs of these patients, our team designed and developed a custom adaptor to assist service members who would otherwise not be able to use a PCA. Patient feedback of the device indicated a positive response, improved independence, and overall satisfaction during inpatient hospitalization.