Patient-controlled Analgesia Modalities Research Articles

Patient-controlled Analgesia (PCA): an Overview About Methods, Handling and New Modalities

Patient-controlled analgesia (PCA) is one of the well established methods for the treatment of postoperative pain. A cochrane-review concluded that PCA is associated with better postoperative pain ratings and improved patient-satifaction compared to traditional way of administering opioids. Some prerequisites concerning patient selection, education of the patient and the medical staff, and supervision during PCA therapy are mandatory for a safe use of PCA. Current PCA modalities (intravenous and epidural routes of application) are expanded by newer, less invasive routes of drug administration, e.g. by the iontophoretic transdermal and the sublingual route. Their role in improving safety and the quality of pain therapy on the one hand side, and costs on the other hand side are discussion.

Sufentanil sublingual tablet system for the management of postoperative pain

ABSTRACTIntroduction: Intravenous patient-controlled opioid analgesia has been an important improvement in addressing insufficient management of acute postoperative pain for over 40 years. However, there are number of weaknesses for intravenous patient-controlled analgesia, including operator and device error, intravenous line patency issues, and risk of catheter-related infection, all of which contribute to the complications and increase in cost of care. The sublingual sufentanil tablet system is a major evolution in both drug and technological management of postoperative pain.Areas covered: We reviewed the use of the sublingual sufentanil tablet system in management of moderate to severe postoperative pain in hospitalized patients, with a particular focus on the pharmacological properties of sufentanil and clinical use in different surgical patients.Expert opinion: The sublingual sufentanil tablet system can decrease intravenous opioid based patient-controlled analgesia related complications and safety issues. Current clinical studies have demonstrated this noninvasive-novel system to be safe and effective in management of acute pain in the postsurgical setting. Researchers should focus on comparing it with other available patient controlled analgesia modalities and evaluating the efficiency and cost effectiveness of the sublingual sufentanil tablet system.

Sublingual Sufentanil: A Review in Acute Postoperative Pain.

The sufentanil sublingual tablet system (SSTS; Zalviso(®)) is a novel patient-controlled analgesia (PCA) device intended to overcome some of the drawbacks of opioid-based intravenous PCA (IV-PCA). Based on the results of three phase III studies, the SSTS has been approved in the EU for the management of acute moderate to severe postoperative pain in adults in a hospital setting. In a head-to-head comparison with morphine, the gold standard for opioid-based IV-PCA, the SSTS was associated with a more rapid onset of analgesia and higher rates of success, based on patient and healthcare professional global assessments of the method of pain control. Patients and healthcare professionals also rated the SSTS as being easier to use and expressed a greater level of overall satisfaction with this device. The SSTS was generally well tolerated, with an adverse event profile typical of that of other opioids and generally similar to that of placebo. By virtue of its preprogrammed, noninvasive design, the SSTS avoids the risk of pump programming errors and other complications (e.g. infections and analgesic gaps) that can occur with IV-PCA technology; it also imposes less restriction on postoperative mobility. As such, the SSTS provides an effective alternative to opioid-based IV-PCA for the management of acute moderate to severe postoperative pain. Future studies should ideally focus on evaluating the relative cost effectiveness of the SSTS and comparing it with other available needle-free PCA modalities.

Development and validation of a new instrument to evaluate the ease of use of patient-controlled analgesic modalities for postoperative patients

Objective: To describe the development and psychometric evaluation of a questionnaire assessing the ease of use that patients associate with patient-controlled analgesia (PCA) modalities.Methods: Qualitative interviews were conducted with patients who had experience with intravenous (IV) PCA for postoperative pain management to generate items relevant to the ease of using PCA modalities. The content validity of the resulting questionnaire was examined through follow-up patient interviews, and an expert panel reviewed the questionnaire. Cognitive debriefing interviews were conducted with patients to determine the clarity and content of the instructions, items, and response scales, and the ease of completing the instrument. Psychometric evaluation was performed with patients who had undergone surgery and received IV PCA for postoperative pain management. Item and scale quality and the internal consistency reliability of the questionnaire were assessed. Construct validity was evaluated by examining the relationship between subscales of the questionnaire with patient-reported outcome measures. Known-groups validity was determined by assessing the instrument's ability to differentiate between patients with versus without an IV PCA problem. A potential limitation of this study was the exclusive sampling of patients who had experience with IV PCA.Results: The Patient Ease-of-Care (EOC) Questionnaire included 23 items in the following subscales: Confidence with Device, Comfort with Device, Movement, Dosing Confidence, Pain Control, Knowledge/Understanding, and Satisfaction. Coefficient alpha reliability estimates were ≥0.66 for Overall EOC (includes all subscales except Satisfaction) and all EOC subscales. Construct validity was supported by the moderate relationship between the Pain Control subscale and measures of pain severity and pain interference; additional evidence of construct validity was provided by correlations of the Confidence with Device subscale, the Satisfaction subscale, and Overall EOC with measures of pain severity, pain interference, and satisfaction. Significant mean score differences were reported between participants with and without IV PCA problems for Overall EOC and for the Comfort with Device, Confidence with Device, Movement, Pain Control, and Satisfaction subscales indicating known-groups validity.Conclusions: Results provide evidence for the reliability and validity of the Patient EOC Questionnaire as a measure of the ease of use that patients associate with PCA systems and may be useful for evaluating emerging PCA modalities.

New and emerging analgesics and analgesic technologies for acute pain management

Purpose of review Recent advances in drug delivery technology have provided new means of delivering medications with improved efficacy and safety. This review details developments in drug delivery recently made available or in development with the potential to better deliver analgesia. Recent findings Patient-controlled analgesia of intravenous medications was a major advance in drug delivery technology that allowed opioids to be administered more effectively and more safely. Extension of this technology to medications not administered intravenously has further broadened therapeutic options in the treatment of acute pain. Improvements in sustained-release formulations and patient-controlled analgesia modalities that are not catheter-based confer the potential to deliver analgesia less invasively. Receptor-specific antagonists allow opioids to be administered with fewer untoward side effects. Summary New routes of administration allow familiar medications to be utilized with greater clinical efficacy. Elimination of the need for indwelling catheters may reduce both the frequency of analgesic gaps and catheter-related complications. Physicians need to be familiar with developments in drug delivery technologies to be able to effectively utilize analgesics as part of well designed multimodal regimens to bring effective and well tolerated analgesia to patients with acute pain.

New and emerging analgesics and analgesic technologies for acute pain management

Recent advances in drug delivery technology have provided new means of delivering medications with improved efficacy and safety. This review details developments in drug delivery recently made available or in development with the potential to better deliver analgesia. Patient-controlled analgesia of intravenous medications was a major advance in drug delivery technology that allowed opioids to be administered more effectively and more safely. Extension of this technology to medications not administered intravenously has further broadened therapeutic options in the treatment of acute pain. Improvements in sustained-release formulations and patient-controlled analgesia modalities that are not catheter-based confer the potential to deliver analgesia less invasively. Receptor-specific antagonists allow opioids to be administered with fewer untoward side effects. New routes of administration allow familiar medications to be utilized with greater clinical efficacy. Elimination of the need for indwelling catheters may reduce both the frequency of analgesic gaps and catheter-related complications. Physicians need to be familiar with developments in drug delivery technologies to be able to effectively utilize analgesics as part of well designed multimodal regimens to bring effective and well tolerated analgesia to patients with acute pain.

Creation of a Novel Recuperative Pain Medicine Service to Optimize Postoperative Analgesia and Enhance Patient Satisfaction

Many patients have difficulty with pain control after transition from patient-controlled analgesia modalities to oral analgesics. The creation of a Recuperative Pain Medicine (RPM) service was intended to bridge this gap in pain management at the Hospital for Special Surgery. Specific goals were to improve patient and staff satisfaction with management of postoperative oral analgesics by improving clinical care, administrative policies, and patient and staff education. Primary outcome measures for improved satisfaction were Press Ganey surveys and staff surveys. From inception in Aug 2007 to Dec 2008, RPM has seen 6,305 patients for discharge planning and education and 997 patients for pain management consultation. Administrative and educational accomplishments have included creation of a patient "Helpline" for emergent phone questions regarding postdischarge home pain medications, a policy for prescribing pain medications for home discharge, patient education booklets, a pain management webpage on the Hospital for Special Surgery website, and direct education of staff. Press Ganey measurements of patient satisfaction increased from 87th percentile up to the 99th percentile among peer institutions since the implementation of RPM. Staff satisfaction was 92% positive regarding the RPM service's function and patient management. An RPM appears to be an effective means to optimize postoperative pain management after transition off patient-controlled analgesia devices. Further research is needed to ascertain the exact cost-benefit and potential impact on postoperative quality-of-life measurements.

Advances in patient-controlled analgesia: the role of fentanyl ITS

Effective pain relief is an essential component of a patient's peri-operative care package. Good analgesia has been shown to reduce the incidence of cardiovascular, respiratory and thrombo-embolic complications following surgery. Satisfactory analgesia facilitates early patient ambulation following surgery, which may reduce in-patient stay. Patient-controlled analgesia (PCA) systems are a well established standard therapy for acute post-operative pain; however some practical limitations limit their clinical utility. The fentanyl inotophoretic transdermal system (ITS) is a novel self-contained needle-free PCA device, which delivers boluses of fentanyl transdermally. This system has been shown to provide analgesia equivalent to conventional PCA modalities, with unique design features that may confer advantages to patients and staff, including facilitating patient mobilization in the post-operative phase. This review will discuss the technology of iontophoretic systems, the pharmacology of transdermal fentanyl delivery, and some practical implications of the fentanyl ITS.

Ease of care with patient controlled analgesia systems: questionnaire development and validation

This paper is a report of the development and validation of two questionnaires assessing ease of caring for patients receiving patient controlled analgesia from the perspectives of nurses and physical therapists. While studies have assessed patient satisfaction with and preference for patient controlled analgesia modalities, no instruments have been developed to assess the ease of providing care (ease of care) for patients receiving patient controlled analgesia from nurses' and physical therapists' perspectives. Nurses and physical therapists participated in focus groups during 2003 to identify concepts associated with caring for patients receiving intravenous patient controlled analgesia. Based on these discussions, items were developed and included in draft questionnaires. Content validity of draft questionnaires was assessed, and final questionnaires were developed. Psychometric properties of the final questionnaires were assessed using data from 79 nurses and 80 physical therapists from two clinical trials conducted during 2004 and 2005 to compare the efficacy and safety of two modalities of patient controlled analgesia. The Nurse and Physical Therapist Ease of Care Questionnaires had 22 items addressing three aspects of patient care: time-efficiency (time-consuming subscale), ease of use/convenience (bothersome subscale), and satisfaction (satisfaction subscale). All subscales on both questionnaires demonstrated evidence of internal consistency reliability, and subscale-to-subscale correlations suggested that the time-consuming and bothersome subscales contribute equally to overall ease of care. The subscales were statistically significantly correlated with clinical measures. These instruments may be valuable for assessing the impact of patient controlled analgesia modalities on patient care for these healthcare providers.

Improving Patient and Nurse Outcomes: A Comparison of Nurse Tasks and Time Associated With Two Patient-Controlled Analgesia Modalities Using Delphi Panels

Increased demand on nursing time may adversely affect nurse satisfaction and patient outcomes. Technologies to reduce nursing time and burden may improve patient care. Two Delphi panels assessed the perceived nursing time of fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) for postoperative pain management. The panels were asked to estimate the time spent on individual nursing tasks from a list. The Clinical Trial panel ( n = 14) was composed of nurses who participated in two clinical trials, and data for both PCA modalities were collected from this panel. The routine practice panel ( n = 13) was composed of nurses from various hospital units, and only data for IV PCA were collected from this panel. From the Clinical Trial panel, the estimated total average task time was 251 minutes for IV PCA and 210 minutes for fentanyl ITS. From the Routine Practice panel, the estimated total average task time was 163 minutes for IV PCA. Thirteen extra tasks were identified by the Clinical Trial panel to be associated only with IV PCA, and these eliminated steps primarily explained the estimated total nursing time difference between IV PCA and fentanyl ITS. According to the two Delphi panels, the perceived nursing time consumed was less and the number of tasks was lower for fentanyl ITS than for IV PCA. This benefit associated with fentanyl ITS may lead to other positive outcomes, such as improved nurse satisfaction and improved patient outcomes.

Current practices for postoperative pain management in Europe and the potential role of the fentanyl HCl iontophoretic transdermal system

Survey results continue to reveal that postoperative pain is insufficiently managed throughout Europe and the rest of the world. However, the efficient use of existing resources, as well as the introduction of novel technologies, may aid in its improvement. Use of an acute pain service has the potential to improve pain management through specialized patient care and utilization of effective analgesic techniques. Multimodal analgesic techniques, which include adjuvant non-opioids and/or regional analgesic techniques, can provide effective analgesia and reduce the amount of systemic opioids (or obviate the need) for postoperative pain management. Patient-controlled analgesia modalities may also offer improvements to pain management, as in practice they provide pain relief superior to the intermittent administration of bolus doses of opioids. A novel patient-controlled analgesia modality that has been approved by the European Medicines Evaluation Agency (EMEA) for the treatment of acute, moderate-to-severe pain is the needle-free, pre-programmed fentanyl HCl iontophoretic transdermal system. This system was shown in a recent US clinical trial to be comparable in efficacy to a standard regimen of morphine intravenous patient-controlled analgesia. Adverse events associated with the use of the fentanyl iontophoretic transdermal system are generally similar to those experienced by patients using intravenous morphine patient-controlled analgesia. Considerations regarding the selection of patients for treatment with the fentanyl iontophoretic transdermal system are similar to those with other patient-controlled analgesia modalities; sufficient upper limb mobility and alertness are required to operate the system. Utilization of the fentanyl iontophoretic transdermal system, together with the guidance of an effective acute pain service, may lead to improvements in postoperative pain management.

Patient-controlled analgesia: Finding a balance between cost and comfort

Purpose. Despite the growing movement in acute pain management, acute postoperative pain continues to be undermanaged. Although numerous clinical practice guidelines for pain management have been published throughout the last 12 years, inadequate pain relief remains a significant health care issue. Insufficient dosage of analgesics is a common problem, and therapy for those patients still with pain represents a considerable health care dilemma. Summary. Patient-controlled analgesia (PCA) refers to a process in which patients determine when and how much medication they receive, regardless of analgesic technique. Patient-controlled modalities using intravenous (i.v.) and epidural routes have dramatically improved postoperative pain management. PCA has emerged as an effective way for patients to manage their pain, allowing self-administration of small doses of analgesics to maintain a certain level of pain control. PCA is most commonly delivered via an intravenous or epidural route, and while patient satisfaction is higher with PCA than with conventional methods of analgesic administration, the invasiveness, costs, health care resources, and risk of errors associated with currently available modalities may limit their utility. The overall effectiveness of any analgesic technique depends on both the degree of pain relief and the incidence of side effects or complications. These adverse events of acute pain complicate postoperative recovery and may lead to longer hospital stays, as well as increased health care costs. Several new PCA modalities are being developed to address these limitations. These systems deliver drugs through a variety of routes (for example, transdermal). Most notable is a self-contained, credit card-sized fentanyl transdermal patient-activated system. It provides pain relief therapeutically equivalent to that of standard regimen of morphine i.v. PCA, with pharmacokinetics similar to those of intravenous fentanyl infusion. Fentanyl HCl patient-activated transdermal systems (PATS) may be an effective, noninvasive alternative to currently available i.v. PCA modalities. Whichever drug or device is utilized, the overall success relies on the expert supervision of nurses, pharmacists, and anesthesiologists in an acute pain service. Conclusion. Current PCA techniques using i.v. or epidural administration have limitations. Development of new technology offering alternative routes for PCA administration is at the forefronts of PCA research.

Patient-controlled analgesia: Finding a balance between cost and comfort

Despite the growing movement in acute pain management, acute postoperative pain continues to be undermanaged. Although numerous clinical practice guidelines for pain management have been published throughout the last 12 years, inadequate pain relief remains a significant health care issue. Insufficient dosage of analgesics is a common problem, and therapy for those patients still with pain represents a considerable health care dilemma. Patient-controlled analgesia (PCA) refers to a process in which patients determine when and how much medication they receive, regardless of analgesic technique. Patient-controlled modalities using intravenous (i.v.) and epidural routes have dramatically improved postoperative pain management. PCA has emerged as an effective way for patients to manage their pain, allowing self-administration of small doses of analgesics to maintain a certain level of pain control. PCA is most commonly delivered via an intravenous or epidural route, and while patient satisfaction is higher with PCA than with conventional methods of analgesic administration, the invasiveness, costs, health care resources, and risk of errors associated with currently available modalities may limit their utility. The overall effectiveness of any analgesic technique depends on both the degree of pain relief and the incidence of side effects or complications. These adverse events of acute pain complicate postoperative recovery and may lead to longer hospital stays, as well as increased health care costs. Several new PCA modalities are being developed to address these limitations. These systems deliver drugs through a variety of routes (for example, transdermal). Most notable is a self-contained, credit card-sized fentanyl transdermal patient-activated system. It provides pain relief therapeutically equivalent to that of standard regimen of morphine i.v. PCA, with pharmacokinetics similar to those of intravenous fentanyl infusion. Fentanyl HCl patient-activated transdermal systems (PATS) may be an effective, noninvasive alternative to currently available i.v. PCA modalities. Whichever drug or device is utilized, the overall success relies on the expert supervision of nurses, pharmacists, and anesthesiologists in an acute pain service. Current PCA techniques using i.v. or epidural administration have limitations. Development of new technology offering alternative routes for PCA administration is at the forefronts of PCA research.

The Fentanyl HCl Patient-Controlled Transdermal System (PCTS)

Inadequate pain control in the postoperative period not only contributes to patient discomfort, but also causes physiological changes that may result in increased risk of myocardial ischaemia, deep vein thrombosis and pulmonary embolism. These events complicate postoperative recovery and may lead to longer hospital stays as well as increased healthcare costs. Patient-controlled analgesia (PCA) has emerged as an effective way for patients to manage their pain, allowing self-administration of small doses of analgesics to maintain a certain level of pain control. PCA is most commonly delivered via an intravenous (IV) or epidural route, and while patient satisfaction is higher with PCA than with conventional methods of analgesic administration, the invasiveness, costs and risk of errors associated with currently available modalities may limit their utility. These systems also require significant healthcare resources, as nurses must manually program the pumps to deliver the correct amount of medication. Several new PCA modalities are being developed to address these limitations. These systems deliver drug through a variety of routes, including nasal transmucosal and transdermal. Most notably, a self-contained, credit card-sized, transdermal PCA system is currently in the final stages of development. The fentanyl HCl patient-controlled transdermal system (PCTS; IONSYS, Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ) uses an imperceptible, low-intensity direct current to transfer fentanyl on demand across the skin into the systemic circulation. This compact system is patient-activated, can be applied to the patient's upper arm or chest, and is designed to manage moderate-to-severe pain requiring opioid analgesia. The system delivers a preprogrammed amount of fentanyl HCI over 10 minutes, for a total of 80 doses, or for 24 hours, whichever occurs first. The on-demand dosing and pharmacokinetics of this system differentiate it from the passive transdermal formulation of fentanyl designed for the management of chronic pain. Clinical studies have shown that the fentanyl HCl PCTS is effective in the management of acute postoperative pain. These studies have also demonstrated that the system is safe and well tolerated by patients.

Patient-controlled Modalities for Acute Postoperative Pain Management

Although numerous clinical practice guidelines for pain management have been published throughout the last 12 years, inadequate pain relief remains a significant health care issue. Several patient-controlled analgesia (PCA) modalities are currently available for the treatment of acute postoperative pain, including intravenous (IV) PCA, epidural (PCEA), and oral PCA. Although PCEA and IV PCA are both commonly used modalities, IV PCA is considered the standard of care for postoperative pain management. Limitations of this modality do exist, however. Consequently, noninvasive PCA systems are under development to circumvent many of these limitations, including the fentanyl hydrochloride patient-controlled transdermal system (PCTS); (IONSYS Ortho-McNeil Pharmaceutical, Raritan, NJ) and a number of patient-controlled intranasal analgesia (PCINA) delivery systems. The objective of this article is to review the PCA modalities currently in use and to discuss those in development for the treatment of acute postoperative pain.

An iontophoretic, fentanyl HCl patient-controlled transdermal system for acute postoperative pain management

Patient-controlled modalities using intravenous or epidural routes have dramatically improved postoperative pain management. However, acute post-operative pain continues to be undermanaged. Intravenous patient-controlled analgesia (PCA), the current standard of care for acute postoperative pain management, requires the patient to be attached to a staff-programmed pump apparatus via an intravenous catheter and tubing, rendering it invasive and mobility-limiting. An innovative, needle-free, iontophoretic, fentanyl HCl patient-controlled transdermal system (PCTS) is being developed for acute postoperative pain management. Fentanyl HCl PCTS is a compact, self-contained system that is easily applied to the upper outer arm or chest. It provides pain relief therapeutically equivalent to that of a standard regimen of morphine intravenous PCA, with pharmacokinetics similar to those of intravenous fentanyl infusion. Fentanyl HCl PCTS may be an effective, non-invasive alternative to currently available PCA modalities.