Remifentanil PCIA for labor analgesia: Does it work? Is it safe?

SP22.1 Remifentanil PCIA has no place in labor analgesia

BackgroundTo collect updated information about pharmacological labour analgesia in Norway, especially systemic opioids and epidural. Evaluation of efficacy and safety with remifentanil intravenous patient‐controlled analgesia (IVPCA) for pain relief during labour. To compare remifentanil IVPCA with epidural analgesia (EDA) regarding efficacy and safety during labour.MethodsIn paper I, two national surveys identified Norwegian labour analgesia methods and changes during the study period (2005–2008). Paper II is a prospective, observational study of analgesic efficacy and safety with remifentanil IVPCA. Paper III is a prospective, randomized controlled trial comparing remifentanil IVPCA with EDA regarding analgesic efficacy and safety.ResultsThe surveys in paper I found the frequency of EDA in Norwegian hospitals to be increasing, but still low (25.9%) compared with other western countries. Nitrous oxide and traditional systemic opioids, like pethidine, were frequently used. In paper II, remifentanil IVPCA was found to give satisfactory labour analgesia in more than 90% of the parturients with an average maximal pain reduction of 60%. Maternal oxygen desaturation and sedation were acceptable, and neonatal data reassuring. In paper III, a randomized controlled trial found remifentanil IVPCA and EDA to be comparable both regarding analgesic efficacy (pain reduction; Fig. ) and maternal satisfaction. Remifentanil IVPCA produced more maternal sedation and oxygen desaturation; neonatal outcome was reassuring in both groups.Reduction in pain score [visual analogue scale (VAS)] during labour analgesia with patient‐controlled intravenous remifentanil and continuous epidural infusion with ropivacaine and fentanyl.figureConclusionThe frequency of epidural labour analgesia in Norway has increased, but is still relatively low. Nitrous oxide and traditional systemic opioids are frequently used. The clinical practice seems conservative; newer short‐acting opioids are seldom used for systemic labour analgesia. The studies on remifentanil IVPCA revealed adequate pain relief, high maternal satisfaction, and no serious neonatal side effects. There were no differences in analgesic efficacy, maternal satisfaction, and neonatal outcome when comparing remifentanil IVPCA with EDA. However, remifentanil caused maternal sedation and oxygen desaturation. We recommend the use of IVPCA remifentanil as labour analgesia instead of traditional opioids as pethidine and morphine when EDA is not an option. The presence of skilled personnel and close monitoring is mandatory.

Intramuscular Opioid Injections: A Step in the Wrong Direction

Developed by the Task Force on Pain Management, Acute Pain Section: L. Brian Ready, M.D. (Chair), Seattle, Washington; Michael Ashburn, M.D., Salt Lake City, Utah; Robert A. Caplan, M.D., Seattle, Washington; Daniel B. Carr, M.D., Boston, Massachusetts; Richard T. Connis, Ph.D., Woodinville, Washington; Cheryl L. Dixon M.D., Jacksonville, Florida; Lex Hubbard, M.D., Shreveport, Louisiana; and Linda Jo Rice, M.D., Hartford, Connecticut.Submitted for publication December 27, 1994. Accepted for publication December 27, 1994. Supported by the American Society of Anesthesiologists, under the direction of James F. Arens, M.D. Chairman of the Ad-Hoc Committee on Practice Parameters. Approved by the House of Delegates, October 19, 1994. A list of the articles used to develop these guidelines is available by writing to the American Society of Anesthesiologists.Address reprint requests to the American Society of Anesthesiologists: 520 North Northwest Highway, Park Ridge, Illinois 60068-2573.Click on the links below to access all the ArticlePlus for this article.Please note that ArticlePlus files may launch a viewer application outside of your web browser.Key words: Pain: acute; perioperative. Practice guidelines: acute pain management.Practice guidelines are systematically developed recommendations that assist the practitioner and patient in making decisions about health care. These recommendations may be adopted, modified, or rejected according to clinical needs and constraints.Practice guidelines are not intended as standards or absolute requirements. The use of practice guidelines cannot guarantee any specific outcome. Practice guidelines are subject to revision from time to time, as warranted by the evolution of medical knowledge, technology, and practice. The guidelines provide basic recommendations that are supported by analysis of the current literature and by a synthesis of expert opinion, open forum commentary, and clinical feasibility data (Appendix).Acute pain in the perioperative setting has not been specifically defined in the available literature. The Task Force has not given preference to literature based on any particular system of definition or classification. For these guidelines, acute pain in the perioperative setting is defined as pain that is present in a surgical patient because of preexisting disease, the surgical procedure (e.g., associated drains, chest or nasogastric tubes, complications), or a combination of disease-related and procedure-related sources.The purpose of these guidelines is to facilitate the efficacy and safety of acute pain management in the perioperative setting and to reduce the risk of adverse outcomes. A number of adverse outcomes can result from undertreatment of postoperative pain. These include (but are not limited to) thromboembolic and pulmonary complications, extension of time spent in an intensive care unit and/or in a hospital, and reduced patient satisfaction. The principal adverse outcomes associated with management of perioperative pain include (but are not limited to) respiratory depression, brain injury, other neurologic injury, sedation, circulatory depression, nausea and/or vomiting, impairment of bowel function, pruritus, and urinary retention.These guidelines focus on modalities of perioperative pain management that require a higher level of expertise and organizational structure than "as needed" intramuscular or intravenous injections of opioids and that generally provide more effective relief of pain. Examples include (but are not limited to) epidural (and intrathecal) analgesia (EA), intravenous patient-controlled analgesia (PCA), and a number of regional analgesic (RA) techniques. The guidelines are not intended as an exhaustive or detailed consideration of specific techniques or all possible approaches.The specialty of anesthesiology brings an exceptional level of interest and expertise to the area of perioperative pain management. As a consequence, the anesthesiologist is in a unique position to provide leadership in integrating pain management into other aspects of perioperative care and thus improve this area of practice. In this leadership role, the anesthesiologist can contribute further to quality of care by developing and directing institution-wide perioperative analgesia programs that include collaboration with and participation by others, when appropriate.The role of anesthesiologists in managing acute pain extends beyond the perioperative setting. Patients with severe or concurrent medical illness such as sickle cell crisis, pancreatitis, or acute pain related to cancer or cancer treatment also benefit from aggressive pain control. Labor pain is another condition of interest to anesthesiologists. However, the complex interactions of concurrent medical therapies and physiologic alterations make it impractical to address pain management for these populations within the context of this document.These guidelines focus on management of acute pain in the perioperative setting for adult (including geriatric) and pediatric patients. The guidelines apply to inpatient and outpatient surgery. These guidelines are intended for use by anesthesiologists or by individuals who deliver care under the supervision of anesthesiologists.Evidence to support each guideline was carefully sought. The search included a comprehensive review of the published literature, surveys of the opinions of a large panel of consultants with expertise in acute pain management, and the opinions of the members of the Task Force. An indication of the strength of the evidence supporting each guideline is provided.The Task Force defines proactive planning as a process of integrating pain management into the perioperative care of patients. The literature, the panel of consultants, and the Task Force members strongly support the use of proactive planning for postoperative pain management. This support is based on recognized associations between preoperative and intraoperative analgesic techniques for the reduction of pain in the postoperative period.Recommendations: An individualized proactive plan (e.g., a predetermined strategy for postoperative analgesia) should be considered for all surgical patients. Factors that may influence the formulation of a proactive plan include (but are not limited to) type of surgery and expected severity of postoperative pain, underlying medical conditions (e.g., presence of respiratory or cardiac disease, allergies), the risk-benefit ratio of the techniques available, and patients' preferences and/or previous experience with pain. Proactive planning of perioperative pain should be part of the preoperative evaluation by the anesthesiologist and, in collaboration with others (e.g., nurses, surgeons, pharmacists), should be part of an institution's general plan for patient care.Activities that are commonly encompassed by proactive planning include (but are not limited to) (1) obtaining a pain history based on patients' experiences, (2) preoperative pain therapy when appropriate and feasible, (3) intraoperative procedures (e.g., wound infiltration) when appropriate and feasible, and (4) intraoperative or postincisional preparation of patients for postoperative pain management (e.g., initiating EA administration before the completion of surgery). Any treatment plan requires regular assessment and refinement based on the changing responses of individual patients.The available literature suggests that training and experience of hospital personnel (e.g. nurses, house-officers, pharmacists, psychologists) may be helpful in reduction of risk. There is strong agreement among the panel of consultants and the Task Force members that such education, training, and experience also contribute to improved quality of care.Recommendations: Anesthesiologists offering perioperative analgesia services should provide, in collaboration with others as appropriate, ongoing education and training to ensure that hospital personnel are knowledgeable and skilled with regard to the effective and safe use of the available treatment options within the institution. The scope of education should include topics ranging from basic bedside skills for evaluation of acute pain to an understanding of sophisticated pharmacologic techniques (e.g., PCA, EA, and various RA techniques) and nonpharmacologic techniques (e.g., relaxation, imagery, hypnotic methods). The need for education and training is ongoing as new personnel enter an institution and as modifications in therapeutic approaches are made.The panel of consultants and the Task Force members regard the concept of education of patients and families in planning and participation in perioperative pain control as being important to their comfort and well-being.Recommendations: Anesthesiologists offering perioperative analgesia services should provide, in collaboration with others as appropriate, education to patients and families regarding their roles in achieving comfort, reporting pain, and using the recommended analgesic methods to optimal benefit. Common misconceptions about the risk of side effects and addiction should be dispelled. Educational methods that facilitate optimal care of patients using PCA and other sophisticated methods might include (but are not limited to) discussion of analgesic methods at the time of the pre-anesthetic evaluation, brochures and video tapes to educate patients about therapeutic options, and discussion at the bedside during postoperative visits.The panel of consultants and the Task Force members strongly support the concept of assessment and documentation of response to perioperative pain therapy as important to effective care. Unless the response to pain therapy is regularly evaluated, there is no basis for rational, individualized therapy.Recommendations: Anesthesiologists offering perioperative analgesia services should use, in collaboration with others as appropriate, pain assessment instruments to facilitate the regular evaluation and documentation of pain, the effects of pain therapy, and side effects caused by the therapy (Table 1and Table 6templates 1 and 6).The panel of consultants and the Task Force members support the concept of 24-hour availability of anesthesiologists providing perioperative pain management as being important for maximizing patient comfort and safety. The condition of patients after surgery is frequently dynamic, and analgesic needs may change at any time.Recommendations: Most analgesic techniques place patients at some risk for side effects of complications that require prompt medical evaluation. Anesthesiologists responsible for perioperative analgesia, in collaboration with others as appropriate, should be available at all times to consult with ward nurses, surgeons, or other involved physicians and assist in evaluating patients who are experiencing problems with any aspect of postoperative pain relief.The available literature suggests that institutional protocols and procedures for ordering, administering, discontinuing, and transferring responsibility for pain management are helpful in providing effective and continuous pain control. The Task Force regards the use of institutional policies and procedures as a logical part of interdisciplinary management of perioperative pain, and there is strong agreement from the panel of consultants that this approach is beneficial. The development of hospital-wide policies and procedures helps standardize clinical practice using techniques such as PCA, EA, and various RA techniques (Table 2and Table 3templates 2 and 3). Standardization promotes safety and creates a framework for customization of care. Routine use of bedside documentation encourages caregivers to continually reevaluate pain treatment and respond to inadequate therapy in a timely manner. Daily evaluation, planning, and written documentation by those who are medically responsible for pain relief help establish the importance of a formal and structured approach to pain management (Table 4, Table 5, Table 6, Table 7templates 4-7).Recommendations: Anesthesiologists offering perioperative analgesia services should participate in developing, in collaboration with others as appropriate (especially nurses), standardized institutional policies and procedures for ordering, administering, discontinuing, and transferring responsibility for postoperative pain management. Policies (the foundation or "ground rules" for practice) and procedures (outlining the "how to" aspects of applying policies to patient care) should be readily available on each patient care unit. The polices and procedures also serve as ongoing educational and informational references.The literature strongly supports the efficacy and safety of three techniques used by anesthesiologists for the control of pain in the perioperative setting: (1) PCA with systemic opioids, (2) EA with opioids or opioid/local anesthetic mixtures (or intrathecal opioids), and (3) RA techniques, including (but not limited to) intercostal blocks, plexus infusions, and local anesthetic infiltration of incisions. The literature indicates that these three techniques used by anesthesiologists have no higher incidence of side effects than less effective techniques for perioperative pain management. The panel of consultants and the Task Force members strongly support the use of PCA, EA, and RA by anesthesiologists when appropriate and feasible.Recommendations: To meet the diverse needs of individual patients, anesthesiologists who manage perioperative pain should make available as appropriate a variety of effective therapeutic options such as PCA, EA, and RA.During the administration of anesthetics for surgery, the needs of many patients may best be met by taking advantage of the combined effects of a number of agents. Similarly, there is growing conviction that a multimodality approach (i.e., two or more analgesic agents or techniques used in combination) to providing postoperative analgesia has advantages over the use of a single modality.The literature supports the efficacy of two or more analgesic techniques (including nonpharmacologic methods) used in combination for the control of perioperative pain, especially when different sites and/or mechanisms of action are involved and/or when synergy of effect is achieved. In addition, the literature indicates that multimodality approaches are associated with side effects no greater than those resulting from single analgesic techniques for perioperative pain management. The panel of consultants and the Task Force members support the use of multimodality techniques when appropriate and feasible.Recommendations: Anesthesiologists managing perioperative pain should make available as appropriate a variety of analgesic techniques and should consider their use in combination under appropriate circumstances.Although dedicated individuals can improve perioperative pain control for the individual patients they treat, comprehensive programs provide optimal analgesia throughout an institution. Such programs have been advocated by national and international pain specialty societies [1,2]and the Federal government.* The Task Force strongly believes that, based on training, knowledge, skills, interest, and historical innovation, anesthesiologists are uniquely qualified to provide leadership within their institutions in developing and managing perioperative pain management programs.The panel of consultants and the Task Force members regard organized interdisciplinary activities (e.g., anesthesiologists in collaboration with nurses, surgeons, and pharmacists) as important and optimal in providing effective, safe, and continuous perioperative pain control (Table 8template 8). An essential feature of such an approach should be an ongoing strong working relationship between anesthesiologists and nurses.Recommendations: Anesthesiologists who manage perioperative pain should develop (in collaboration with nurses, surgeons, pharmacists, and others) an organized, interdisciplinary approach to perioperative pain management within their institutions.Pediatric patients (infants and children) present unique problems regarding perioperative pain management for reasons that include differences in the perception of care-givers regarding the need for analgesia, differences in the pharmacology of analgesic medications when used in this group, and the strong emotional components of pain in children. In the past, safe methods for providing analgesia have been underused in pediatric patients because of fear of opioid-induced respiratory depression.The emotional component of pain is very strong in children. Absence of parents, security objects, and familiar surroundings may be perceived by the child to be as painful as the surgical incision. When clear evidence of physical pain is not seen, the tendency of health-care providers is to assume pain is not present and therefore defer treatment. In addition, young childrens' fear of injections makes intramuscular opioids or other methods, which themselves cause discomfort, less acceptable to this group than to adults. Many children will choose to suffer in silence knowing that an expression of pain will result in a dreaded injection.Pain assessment is more difficult in children because, as they grow and develop, cognitive and emotional responses are different from adults and are constantly changing. Special instruments are available to assist young children in self-reporting of pain, and behavioral and physiologic parameters can be employed to assess preverbal children or in those who cannot self-report.The literature strongly supports the effectiveness of a variety of techniques in providing analgesia in pediatric patients. Many of these are the same techniques used in adults, although some techniques (e.g., caudal analgesia) are more commonly used in children. There is strong agreement among the panel of consultants and the Task Force members that it is important to recognize that pediatric patients represent a unique population with special features when planning and providing perioperative analgesia.Recommendations: Anesthesiologists who treat perioperative pain in pediatric patients should be familiar with the special features of this group. Based on that knowledge, pharmacologic and nonpharmacologic strategies for perioperative analgesia appropriate for the age of the child should be offered in a manner that promotes efficacy and safety.Elderly patients are a unique population facing surgery. They may experience physical and mental limitation and may have different attitudes than younger patients with regard to expressing pain and appropriate therapy for it. Altered physiology with aging changes the way analgesic drugs and local anesthetics are distributed and metabolized, frequently necessitating alterations in dosing. There is strong agreement from the panel of consultants and the Task Force members on the importance of recognizing the unique features of geriatric patients in planning and providing perioperative analgesia.The literature indicates that single and multimodality techniques that have been shown to be effective in younger adult patients are also effective (often with reduced drug dose requirements) in geriatric patients without increasing side effects.Recommendations: Anesthesiologists who treat perioperative pain in geriatric patients should be familiar with the special features of this group. In particular, dose reduction for drugs that may cause central nervous system depression should be considered.The increasing trend toward ambulatory surgery poses special problems in perioperative pain management. One of the most common reasons for unanticipated hospital admission in this population is inadequate pain control. Analgesic techniques must provide safe, adequate pain relief for patients who quickly leave the supervised hospital environment. Techniques such as EA and intravenous PCA, which require special nursing and monitoring, are not suitable for such patients, but others such as local anesthetic wound infiltration and oral nonsteroidal antiinflammatory drugs may be very effective.The panel of consultants and the Task Force members strongly agree that the provision of effective analgesia to ambulatory surgery patients is important and beneficial. A limited search of this evolving literature suggests that planning of perioperative analgesia for ambulatory patients including the use of certain procedures (e.g., local anesthetic wound infiltration and certain RA techniques) may improve analgesia without increasing the risk of side effects.Recommendations: Anesthesiologists who care for ambulatory surgery patients should proactively plan therapeutic strategies appropriate for them, recognizing that they are expected to leave the surgical facility within a few hours after the completion of surgery.The Task Force thanks those who responded to surveys on acute pain in the perioperative setting, reviewed guideline drafts, contributed oral and written testimony to the Open Forum, and participated in tests of clinical feasibility.The development of these guidelines included methods recommended in the following publications: (1) Clinical Practice Guidelines--Directions for a New Program, Committee to Advise the Public Health Service on Clinical Practice Guidelines, Division of Health Care Services, Institute of Medicine. Edited by Field MJ, Lohr KN, Washington, D.C., National Academy Press, original document 1990, summary document 1992; and (2) Woolf SH: Manual for Clinical Practice Guideline Development, Washington, D.C., U.S. Department of Health and Human Services. Agency for Health Care Policy and Research, publication number 91-0007, March 1991.The scientific assessment was based on the following statements or evidence linkages. These linkages represent directional hypotheses about relationships between perioperative pain management and clinical outcomes.1. Proactive planning for perioperative pain management improves pain control and reduces adverse outcomes.2. Education and training of hospital personnel improve pain control and reduce adverse outcomes.3. Education and participation of patients and families improve pain control and reduce adverse outcomes.4. Monitoring and documentation activities improve pain control and reduce adverse outcomes.5. Availability of anesthesiologists providing perioperative pain management improves pain control and reduces adverse outcomes.6. Standardized institutional policies and procedures for perioperative pain management improve pain control and reduce adverse outcomes.7. Use of PCA, EA, or RA techniques improves pain control and reduces adverse outcomes.8. Use of multimodality techniques improves pain control and reduces adverse outcomes.9. Organizational characteristics related to perioperative pain management improve pain control and reduce adverse outcomes.10. Pediatric perioperative pain management techniques improve pain control and reduce adverse outcomes.11. Geriatric perioperative management techniques improve pain control and reduce adverse outcomes.12. Ambulatory surgery acute pain management techniques improve pain control and reduce adverse outcomes.Scientific evidence was derived from aggregated research findings, including metaanalyses, and from surveys, open forum presentations, and other consensus-oriented activities. For purposes of literature aggregation, potentially relevant clinical studies were identified via electronic and manual searches of the literature. The search covered a 27-yr period from 1966 through 1993. More than 4,000 articles were identified initially, yielding 465 nonoverlapping articles that addressed the 12 evidence linkages. Studies that could not be analyzed statistically were reviewed and eliminated, yielding 233 articles used in the formal metaanalyses.A directional result for each study was determined initially by classifying the outcome as (1) supporting a linkage, (2) a linkage, or (3) The were to a directional assessment of support for each The literature to linkages EA, and RA as and studies with defined and for formal tests were to continuous and an procedure was to study combined tests were employed as (1) the combined based on of the from the and (2) the combined providing of the studies by each of the by the A procedure based on the for study using 2 2 was used when outcome was An acceptable level was at and were agreement was through assessment of for of the were to ensure among the study To control for a was for each combined search for studies was and no tests for research were from the combined tests for pain reduction were as 1 EA and RA and effect from to effect for all outcomes were (i.e., not for of tests and of effect were in all that the various studies common of the population effect for the linkages. among the Task Force members and two was by using a for agreement were as (1) type of study (2) type of (3) evidence and (4) literature for agreement (1) (2) and (3) linkage, These represent to of of the literature were by of opinions from a panel of anesthesiologists with expertise in acute pain in the perioperative setting and from the opinions of the Task Force were of the linkages (i.e., that they in in pain reduced adverse side and were important for the guidelines to The of consultants supporting each based on these were 1 2 and 12 was to the guidelines after completion of the feasibility of these guidelines into clinical practice was using a of opinions from a panel of anesthesiologists with expertise in acute pain in the perioperative setting. of the responses that these guidelines can be in a large of institutions with of the anesthesiologists that of the guidelines not result in the need to new or of guideline for all was to the who that be the was new of PCA epidural and anesthesiologists were to of the evidence linkages change their clinical the guidelines were The of consultants no change associated with each were as proactive planning education and training education and participation of patients and families and documentation availability of anesthesiologist institutional policies and procedures use of PCA, EA, and RA techniques use of multimodality techniques organizational characteristics pediatric techniques geriatric techniques and ambulatory surgery techniques of the that the guidelines have no effect on the of time spent on a that the guidelines reduce the of time spent For all the in the of time spent on a was the of who an in time spent on a the was Practice Pain or and Agency for Health Care Policy and Washington, D.C., U.S. Department of Health and Human Services, by with special interest in the used in these guidelines can further by writing L. Brian Ready, M.D., Department of Acute Pain of of Seattle,

Review question/objective In parturients who are in active first and second stages of labor, what is the effect of intravenous patient-controlled analgesia with remifentanil on the level of maternal satisfaction and pain reduction from baseline compared to intravenous fentanyl? Background Pain during childbirth has been around since the very first birth of a human. The attempts to alleviate pain during childbirth are long standing with efforts made by midwives, obstetrical nurses, obstetricians, and anesthesia providers. Almost all women in labor experience pain at varying degrees which is mediated by uterine activity, cervical dilation, and fetal position. The process of childbirth is categorized into three stages. The first stage of labor is when the cervix slowly dilates, shortens and thins. Pain is usually felt in the abdomen and the lower back with each contraction. The pain typically intensifies as the cervix reaches full dilation and the fetus moves down in the pelvis towards the birth canal. The second stage of labor is when the cervix is fully dilated and effaced (shortened and thinned) and the fetus is pushed through the birth canal. Pain during this stage of labor is intensified further and is usually felt in the lower pelvic and vaginal areas. It then reaches to the perineum as final stretching occurs to accommodate the large head of the fetus. The third stage of labor is when the placenta is delivered and is associated with comparatively little pain.1 In recent years, continuous laboring epidural catheters (CLEs) have been a mainstay in the delivery of analgesia for the laboring parturient.2-5 They are the most effective and satisfying analgesic delivery method for the control of pain during labor.6,7 Although a proven, safe and effective method of pain control, CLEs are not an acceptable option for all.8 Many institutions may not have 24 hours a day availability of anesthesia providers to offer this option of pain relief during labor. Some laboring women may have infective processes, coagulopathies, spinal/neurological abnormalities, and other physiologic disorders that are contraindications to the placement of a CLE. Additionally, some women may be too fearful of potential complications while others are physically unable to cooperate for the time it takes to administer the CLE. The fear of potential complications is not unfounded, as the placement of the epidural does not come without risk. Incorrect CLE placement can result in intravascular injection, intraneural injection, or intrathecal injection all of which can have catastrophic consequences.9 Before the advent of CLEs, intravenous (IV) narcotics were the backbone of pain management for labor. IV narcotics are still currently in use on a regular basis for women who are in early labor, up to just a few hours before delivery. Narcotics are a powerful class of analgesics with many drugs available that have varying degrees of potency and duration. Commonly used narcotics for labor and delivery include morphine, meperidine, butorphanol, nalbuphine and fentanyl. The choice of which one to use is based on speed of onset, duration of action, associated side effects, provider preference and maternal preference. In spite of well-known sedation properties that exceed its analgesic properties, meperidine continues to be the most commonly used opioid worldwide during labor and delivery.6,8,10-12 This is mostly due to its ease of administration and cost effectiveness.3 In addition to the sedation properties being greater than the analgesic properties, it is well documented in the literature that meperidine causes significant neonatal respiratory depression.8,10,12 With these negative side effects in mind, studies recommend the use of fentanyl as the first line drug to be given for labor analgesia over meperidine.13,14 Fentanyl appears to be a better suited drug for labor, but is still associated with a 44% incidence of a moderately depressed neonate with low Appearance, Pulse, Grimace, Activity and Respiration (APGAR) scores.8 Standard obstetrical practice does not allow administration of either fentanyl or meperidine within two to four hours of delivery or after cervical dilation has reached eight centimeters. This leaves a void in pain relief options for parturients in the later stage of labor and delivery. Patient controlled analgesia (PCA) is a method of drug delivery for pain control that is very familiar to most bedside practitioners. It is a useful strategy for providing pain relief during labor and delivery by establishing plasma levels of narcotics that the parturient can increase quickly and easily as the pain level increases. Remifentanil was first introduced into the United States drug market in 1995 and has slowly found its way into use for labor and delivery. Remifentanil is an ultra short-acting and potent narcotic metabolized by non-specific tissue and plasma esterases. The hydrolysis of the ester link by tissue and plasma esterases affords lack of drug accumulation.15 It has been well documented in the literature that the fast onset and elimination of remifentanil matches well with the onset and duration of contractions during active labor making it an ideal choice for PCA during labor.5,16-18 Rapid elimination permits the titration of an infusion without the concern for prolonged duration of effect or drug accumulation. The safety of mother and neonate are of concern when considering which potent narcotic to administer. Numerous studies have since been published in support of using remifentanil PCA to effectively and safely reduce the pain of labor throughout its duration up to birth.8,10,14,19-26 Favorable neonatal outcomes and proven safety hold far greater implications than maternal efficacy when considering this analgesic for managing labor pain. There is one systematic review published through the International Anesthesia Research Society that compares the effectiveness of pain control of remifentanil during labor to that of meperidine.24 The conclusion of this systematic review revealed remifentanil to be a better analgesic than meperidine and it provided better satisfaction scores. This is not surprising considering the well-known weak analgesic properties of meperidine. There are two studies in the literature comparing the effectiveness of pain reduction and satisfaction of remifentanil and fentanyl during labor.6,12 Each study produced a different conclusion. A systematic review is proposed because of these differences and as a means to focus the body of knowledge concerning this question. Preliminary literature searches have revealed no systematic reviews published comparing remifentanil PCA and fentanyl via any delivery method. Therefore, the purpose of this systematic review is to compare the effectiveness of remifentanil versus fentanyl when used for labor analgesia as measured by maternal satisfaction and reduction in pain score from baseline. The overall intent is to bring together the existing evidence on remifentanil use in labor to provide more insight in choosing the best treatment for intravenous pain management. The results of this systematic review could have an important impact on the decision making process concerning which analgesic to administer during labor. This is important in light of the favorable safety profile of remifentanil when compared to the significant neonatal depression associated with fentanyl. If the systematic review finds that maternal satisfaction and reduction in pain score are better when using remifentanil, a recommended change in practice would be offered which could result in increased safety for the neonate.

BACKGROUND Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries. However, only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery. The authors' primary purpose in this randomized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative: patient-controlled intravenous analgesia. METHODS Seven hundred fifteen women of mixed parity in spontaneous labor at full term were randomly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia. Epidural analgesia was maintained with a continuous epidural infusion of 0.125% bupivacaine with 2 microg/ml fentanyl. Patient-controlled analgesia was maintained with 10-15 mg meperidine given every 10 min as needed using a patient-controlled pump. Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman randomized in the study. RESULTS A total of 358 women were randomized to receive epidural analgesia, and 243 (68%) of these women complied with the epidural analgesia protocol. Similarly, 357 women were randomized to receive patient-controlled intravenous meperidine analgesia, and 259 (73%) of these women complied with the patient-controlled intravenous analgesia protocol. Only five women who were randomized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief. There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original randomization (epidural analgesia, 4% [95% CI: 1.9-6.2%] compared with patient-controlled intravenous analgesia, 5% [95% CI: 2.6-7.2%]). Similar results were observed for the analysis of the protocol-compliant groups (epidural analgesia, 5% [95% CI: 2.6-8.5%] compared with patient-controlled intravenous analgesia, 6% [95% CI: 3-8.9%]). Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia. CONCLUSIONS Epidural analgesia was not associated with increased numbers of cesarean delivery when compared with a suitable alternative method of analgesia.

Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries. However, only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery. The authors' primary purpose in this randomized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative: patient-controlled intravenous analgesia. Seven hundred fifteen women of mixed parity in spontaneous labor at full term were randomly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia. Epidural analgesia was maintained with a continuous epidural infusion of 0.125% bupivacaine with 2 microg/ml fentanyl. Patient-controlled analgesia was maintained with 10-15 mg meperidine given every 10 min as needed using a patient-controlled pump. Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman randomized in the study. A total of 358 women were randomized to receive epidural analgesia, and 243 (68%) of these women complied with the epidural analgesia protocol. Similarly, 357 women were randomized to receive patient-controlled intravenous meperidine analgesia, and 259 (73%) of these women complied with the patient-controlled intravenous analgesia protocol. Only five women who were randomized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief. There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original randomization (epidural analgesia, 4% [95% CI: 1.9-6.2%] compared with patient-controlled intravenous analgesia, 5% [95% CI: 2.6-7.2%]). Similar results were observed for the analysis of the protocol-compliant groups (epidural analgesia, 5% [95% CI: 2.6-8.5%] compared with patient-controlled intravenous analgesia, 6% [95% CI: 3-8.9%]). Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia. Epidural analgesia was not associated with increased numbers of cesarean delivery when compared with a suitable alternative method of analgesia.

Sharma, Shiv K.; Sidawi, J. Elaine; Ramin, Susan M.; Lucas, Michael J.; Leveno, Kenneth J.; Cunningham, F. Gary Author Information

Enquête nationale prospective sur les alternatives à l'analgésie péridurale obstétricale

Objective To observe the effect of different analgesic methods including patient controlled epidural analgesia （PCEA） and patient controlled intravenous analgesia （PCIA） on stress response and anxiety in surgical patients with lower limb fracture. Methods A total of 120 surgical patients with lower limb fractures were employed and divided randomly into Groups PCEA, PCIA and C （40per group）. All patients were anaesthetized by using combined spinal-epidural anesthesia. After operation, PCEA and PCIA were applied in the patients of Groups PCEA and PCIA, respectively. No analgesic method was employed in the Group C. The dynamic indices including mean blood press （MAP） and heart rate （HR）, blood serum cortisol （COR） and blood sugar （BS） were measured at different time points,ie, T0 （ pre-anesthesia）, T1 （ the end of the operation）, T2 （24 hours after operation） and T3 （48 hours after operation）. The visual analogue pain score was conducted at time points of T1, T2 and T3. The measurement of anxiety score was done at pre-operation and at days 1 and 7 after operation. Results There were no significant changes in HR and MAP of Groups PCEA and PCIA （P〉0.05, compared with T0） at every time point after operation. Whereas, HR and MAP of Group C were increased at time points of T1 and T2 （P 〈 0.05, compared with T0 ）, with statistical difference compared with Groups PCEA and PCIA at the same time points （P 〈 0.05 ）. VAS in Group PCEA was lower than that in Group PCIA at time points of T2 and T3 （ P 〈 0.05）. Meanwhile, VAS in Groups PCEA and PCIA was lower than that in Group C （P〈0. 05）. COR and BS in Group PCEA were significant lower than those in group PCIA at time points of T2 and T3 （P 〈 0. 05 ）. Meanwhile, COR and BS in Groups PCEA and PCIA was lower than that in Group C （P〈0.05 or 〈0.01 ）. Moreover, the changes were more significant in Group PCIA than that in Group PCEA （P 〈 0. 05 ）. The anxiety score in Groups PCEA and PCIA was lower than that in Group C （P 〈 0.05）. Conclusions Two analgesic methods of PCEA and PCIA can provide safe and effective postoperative analgesia and attenuate the stress response and anxiety in surgical patients with lower limb fracture. Meanwhile, PCEA takes more advantages than PCIA. Key words: Anesthesia and analgesia; Stress response; Anxiety

OBJECTIVE: New generation lithotriptors have been introduced into Taiwan for years. These lithotriptors offer an immersion-free treatment and a decrease in shock wave induced pain. Among several different analgesic methods used to overcome the pain experienced during extracorporeal shock wave lithotripsy (ESWL), patient controlled analgesia (PCA) was reported in foreign literature to have effect in pain relief. We test the feasibility of PCA in ESWL in Taiwan. MATERIALS AND METHODS: From March to July 1999, 71 consecutive patients with renal or ureteric stones were enrolled into two groups to have fentanyl infused by PCA or by anesthesiologist. The dose of fentanyl, stone size, location, maximum energy level achieved, number of shock waves given, duration of procedure and pain scores were recorded as the parameters to evaluate the difference between two groups. RESULTS: The fentanyl needed in PCA group and non-PCA group were 19.0±20.0μg. versus 71.7±29.5μg.,(p=0.00).The side effect of fentanyl was lower in PCA group. CONCLUSIONS: PCA decreases narcotic requirement and hence its adverse effect. These advantages favor an outpatient procedure and can be used to quantify the amount of analgesic requirement during lithotripsy. In consideration of safety and comfort, PCA may be an alternative choice of pain control for ESWL.

Medical devices are pervasive throughout modern healthcare, but each device works on its own and in isolation. Interoperable medical devices would lead to clear benefits for the care provider and the patient, such as more accurate assessment of the patient’s health and safety interlocks that would enable error-resilient systems. The Center for Integration of Medicine & Innovative Technology (www.CIMIT.org) sponsors the Medical Device Plug-and-Play Interoperability program (www.MDPnP.org), which is leading the development and adoption of standards for medical device interoperability. Such interoperable medical devices will lead to increased patient safety and enable new treatment options, and the aim of this project is to show the benefits of interoperable and interconnected medical devices.

Objective To compare the effect of remifentanil parturient-controlled intravenous analgesia and sufentanil combined ropivacaine parturient-controlled epidural analgesia in labor, in order to assess the safety and feasibility of remifentanil patient-controlled intravenous analgesia in labor. Methods From June to December 2014, a total of 427 cases of pregnant women who delivered in Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine and demanded for analgesia voluntarily were enrolled as research subjects. According to the analgesia method pregnant women chose for, they were divided into study group (n=159) who received remifentanil parturient-controlled intravenous analgesia and control group (n=268) who received sufentanil combined ropivacaine parturient-controlled epidural analgesia. All the 427 cases of pregnant women were grade Ⅰ-Ⅱ in American Society of Anesthesiologists (ASA), single birth, full term, received analgesia voluntarily and with vaginal trial delivery. The analgesia method in study group was with remifentanil 20 μg/mL, first dose of remifentanil: 0.4 μg/kg, background dose: 0.04 μg/(kg·min), patient controlled analgesia (PCA) dose: 0.4 μg/kg and lockout time: 3 minutes. While the analgesia method in control group was with sufentanil 0.3 μg/mL + 0.068% ropivacaine, background dose: 6~8 mL, PCA dose: 5 mL, and lockout time: 20 minutes. At the time fetus delivered out, 1 mL umbilical artery (UA) blood was exsanguinated immediately and did blood gas analysis. Blood pressure, heart rate, respiratory rate, hemoglobin oxygen saturation by pulse oximetry (SpO2), visual analogue scale (VAS) score and Ramsay sedation score before analgesia, at the onset of analgesia, 1 hour, 2 hours and 3 hours after analgesia of two groups were recorded. The period of effective analgesia, the period of first, second, and third stage of labor, the use of oxytocin, forceps delivery rate, cesarean section rate, Apgar scores, UA blood gas analysis, adverse reactions, and the satisfaction of pregnant women and their families of two groups were also recorded. Statistical methods were analyzed between two groups among those indexes mentioned above. The study protocol was approved by the Ethical Review Board of Investigation in West China Second University Hospital, Sichuan University. Informed consent was obtained from each participant. Results ①There were no statistically significant differences between two groups among the age, body weight, body height, body mass index and gestational age and so on (P>0.05). ②There were no statistically significant differences between two groups among mean arterial pressure, heart rate, breathing rate and SpO2 before analgesia, the onset of analgesia, 1 hour, 2 hours and 3 hours after analgesia (P>0.05). ③The analgesia onset time in study group was (1.0±0.1) minutes which was significantly shorter than that of (15.7±1.9) minutes in control group, and the difference was statistically different (t=126.408, P=0.000). The Ramsay sedation scores in study group at the onset of analgesia and 1 hour after analgesia were (2.4±0.6) score, (2.3±0.4) score which were significantly higher than those of (1.9±0.4) score, (1.9±0.4) score, respectively in control group, and both the differences were statistically significant (t=10.599, 10.722; P=0.000). While there were no statistical differences of Ramsay sedation scores before analgesia, 2 hours and 3 hours after analgesia between two groups (P>0.05). The VAS scores at the onset of analgesia and 1 hour, 2 hours and 3 hours after analgesia in study group were all higher than those in control group, and all the differences were statistically different (P 0.05). There were no statistical differences between two groups in the incidences of vomiting and pruritus (P>0.05). 22.0% (31/141) patients in study group encountered dizziness, which was far higher than that in control group 1.8% (4/228) and the difference was statistically different (χ2=41.535, P=0.000). But the incidence of lower limb numbness in study group (0.7%, 1/141) was lower than that in control group (6.6%, 15/228), and the difference was also statistically significant (χ2=7.236, P=0.007). ⑤The Apgar score, the pH value and base excess level of UA blood gas analysis of the newborn infants between two groups were not statistically significant (P>0.05). ⑥Both two groups obtained high degree of satisfaction from pregnant women and their family, and both the differences between two groups were not statistically significant [pregnant women: 94.3% (150/159) vs 95.1% (255/268), χ2=0.13, P=0.714; their family: 95.0% (151/159) vs 96.3% (258/268), χ2=0.42, P=0.518]. Conclusions Compared to traditional sufentanil combined ropivacaine parturient-controlled epidural analgesia in labor, remifentanil parturient-controlled intravenous analgesia is confirmed secure, effective and convenient. As an alternative mode of labor analgesia, remifentanil patient-controlled intravenous analgesia with background dose 0.04 μg/(kg·min) and PCA dose 0.4 μg/kg can be used under the precondition of ensuring one-to-one beside care, continuous monitoring, oxygen supply and preparation for neonatal resuscitation. Key words: Remifentanil; Analgesia, patient-controlled; Infusions, intravenous; Analgesia, epidural; Sufentanil; Ropivacaine; Pregnant women

Pain management during labor and vaginal birth.

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