Busse et al156 also compared the impact of COT and the same nonopioid pharmacological therapies on functional outcomes assessed with the 36-item Short Form Health Survey. One network meta-analysis of oral agents for knee osteoarthritis was also identified,104 including between 16230 and 9742 participants depending on outcome examined. The panel based these recommendations on the following definitions for COT: (1) patients receiving a 70-day supply of opioids in a 90-day period or (2) an index opioid prescription in the past 4 months followed by at least 2 more opioid prescriptions and having at least a 60-day supply of opioids within the 4-month period. The only studies to include a substantial proportion of people with recurrent acute pain at entry were small (13 to 17 participants) and compared rates of painful events before and after the start of transfusions.187,191,192 None of these studies reported on the impact of chronic transfusions on HRQOL outcomes that are associated with pain and function, thereby making the data using health care utilization as an outcome a likely underestimate of the pain burden. Unfortunately, a majority of interventions were supported by evidence that was of low or very low certainty in the effects. The panels recommendations are divided based on 3 distinct patient populations who have the clear presence of chronic (rather than episodic) pain. Other systematic reviews of multijoint osteoarthritis identified subsequent to the initial evidence review support efficacy of NSAIDs,105-108 although the results overall suggested that acetaminophens effects may not be clinically significant,106,107 and some studies have questioned how many of these results can be attributed to confounding factors rather than treatment effects.103,109 Other evidence suggests that topical NSAIDs have short-term effects but likely are inferior to systemic NSAIDs.110. This variability is reflected in the tailored approach that the panel has put forth for these recommendations. Saving Lives, Protecting People. Administer prophylactic oral penicillin (125 mg twice daily for children younger than three years; 250 mg twice daily for those three years and older) until at least five years of age in all children who are homozygous for sickle hemoglobin. The panel discussed the idea that acupuncture and biofeedback therapies have low risk of harm; however, improper delivery may increase this risk. Antibiotics, hospitalization, and incentive spirometry are indicated for those with acute chest syndrome. A Cochrane systematic review evaluated 26 studies (n = 4893) that included 25 case series and 1 RCT.158 This review concluded that weak evidence existed that clinically significant pain relief occurs in patients who can continue long-term COT. Chelation therapy can effectively remove excess iron in patients with confirmed iron overload.27. There is no one-size-fits-all approach to optimal pain management. Therefore, the panel concluded that validated and agreed-upon end points for SCD pain need to be established and used to be able to compare the efficacy and effectiveness of interventions for acute and chronic pain across studies. Individuals living with SCD suffer from chronic pain. Particular attention was paid to the impact on patient-centered outcomes including time to first analgesic dose, time between analgesic doses, improved pain intensity, need for subsequent ED care or hospitalization, missed days of school or work, HRQOL, and patient satisfaction with care and cost. The panel identified only trivial undesirable effects of the interventions and found that the main barriers to implementation are related to logistical burdens. When used to treat psychiatric conditions, antidepressant medications can increase suicidal ideation in those age <25 years.111 Whether this is true when they are used for chronic pain is unknown, and the indirect evidence base addressed adults and often older adults. Treat pain of patients with SCD promptly. ACS can present on its own or as a complication of a VOC; it requires prompt evaluation and, once diagnosed, early intervention with antibiotic therapy and hospitalization.28,29 During hospitalization for a VOC, incentive spirometry can reduce the risk of ACS.30 When evaluating a new lung infiltrate in a patient with SCD, physicians should consider ACS before assuming the infiltrate represents community-acquired pneumonia. Ensure completion of pneumococcal vaccination series before discontinuation. The document was revised to address pertinent comments, but no changes were made to recommendations. Providers should be aware that patients may inadvertently end up on COT if episodic pain is frequent enough that patients are receiving frequent opioid treatment of recurrent pain. In summary, data from 7 RCTs (n = 1311) showed no difference in physical functioning between opioids and NSAIDs, and small studies of low-quality evidence suggested no difference in physical functioning between opioids and TCAs (2 studies; n = 158) and between opioids and anticonvulsants (3 RCTs; n = 303). The panel discussed the fact that justification for the SCD-specific hospital-based acute care facility model for pain management depends on a sufficient critical mass of patients. Their increasing use led the panel to evaluate the evidence for the impact of these models on outcomes important to patients. Indirect evidence in chronic noncancer pain populations showed that there is increased risk of significant harm related to COT. Time, financial costs, availability, and training of therapists (ie, in chronic pain and SCD) and patient burden can be barriers to these types of psychological treatments that are being recommended. The panels work was performed using Web-based tools (www.surveymonkey.com and www.gradepro.org) and face-to-face and online meetings. Clinicians must make decisions based on the clinical presentation of each individual patient, ideally through a shared process that considers the patients values and preferences with respect to the anticipated outcomes of the chosen option. This recommendation assumes that these hospital-based facilities have readily available code team coverage to ensure delivery of the safest care. The panel identified few undesirable effects of the intervention except for the resources that are required to set up and maintain these facilities. Overall, the balance of effects favors the intervention. For adults and children who seek treatment of acute pain, the ASH guideline panel suggests massage, yoga, transcutaneous electrical nerve stimulation (TENS), virtual reality (VR), and guided audiovisual (AV) relaxation in addition to standard pharmacological management (conditional recommendation based on very low certainty in the evidence about effects ). They may also be used by patients. Time, financial costs, availability, training of therapists (ie, chronic pain and SCD), and patient burden can be barriers to these types of treatments. This nonrecommendation includes bolus infusions and infusions to maintain fluid balance requirements in addition to the types of fluids (eg, normal [0.9%] saline vs half-normal [0.45%] saline) that are used in these infusions. The other recommendations provided in this summary should be used for potential alternatives that could be part of a comprehensive pain management plan. This document may also serve as the basis for adaptation by local, regional, or national guideline panels. Initiate hydroxyurea therapy in adults with sickle cell anemia who have one or more of the following: three or more moderate to severe pain crises in a 12-month period; daily sickle cell pain that affects quality of life; severe or recurrent acute chest syndrome; or severe symptomatic chronic anemia. The panel acknowledges that there was no important uncertainty or variability about how much people value the main outcomes that were considered. Data Sources: This is a summary of and highlights from evidence-based guidelines. Overview of SCD SCD is a genetic disorder that results in the formation of sickled red blood cells (RBCs). Development of these guidelines was wholly funded by ASH, a nonprofit medical specialty society that represents hematologists. There were no studies that addressed some of the a prioridefined patient-centered outcomes, including pain, HRQOL, satisfaction with care, and missed days of school or work. BARBARA P. YAWN, MD, MSc, MSPH, AND JOYLENE JOHN-SOWAH, MD, MPH. For researchers: this recommendation is likely to be strengthened (for future updates or adaptation) by additional research. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The panel selected outcomes of interest for each question a priori, following the approach described in detail elsewhere.24 In brief, the panel first brainstormed all possible outcomes before rating their relative importance for decision making following the GRADE approach.24 While acknowledging considerable variation in the impact on patient outcomes, the panel considered the outcomes in Table 2 critical for clinical decision making across questions. The decision to use such drugs should include a discussion of the risks and the indirect evidence that addresses the benefits of chronic nonopioid therapy for use as a sole pharmacological agent or in combination with an opioid to reduce the total opioid dose. For each recommendation, the panel took a population perspective and came to consensus on the following: the certainty of the evidence, the balance of benefits and harms of the compared management options, and the assumptions about the values and preferences associated with the decision. One systematic review/meta-analysis156 included 42 RCTs (n = 16617) and concluded that opioids were associated with reduced pain compared with placebo on a 10-cm VAS used for pain assessment. Men with SCD who have a history of priapism and/or erectile dysfunction may be particularly at risk, although again, this has not been systematically studied. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Comanagement with adult or pediatric hematology-oncology subspecialists can enhance the family physician's knowledge and overall care of patients with SCD. The ED is the most common site of care delivery for acute pain treatment; however, alternative care delivery models, such as day hospitals and infusion clinics, have emerged. The methods for guideline development are described within the full guideline text (http://www.nhlbi.nih.gov/health-pro/guidelines/sickle-cell-disease-guidelines/index.htm). A thorough explanation of the procedure as well as risks, benefits, and alternative options should be provided to patients and families before the procedure. Therefore, all data reviewed were from published systematic reviews and meta-analyses conducted in other chronic noncancer pain populations. (SOR: consensus), Begin annual screening of persons with SCD for microalbuminuria and proteinuria with spot urine testing by 10 years of age. However, what is less clear is whether the addition of a continuous basal opioid infusion to intermittent opioid delivery offers advantages considering the balance of benefits and harms over intermittent opioid delivery alone. The panel acknowledges that there is a lack of research on patient preferences for this intervention that could inform health equity. After publication of these guidelines, ASH will maintain them through surveillance for new evidence, ongoing review by experts, and regular revisions. It will not cover the management of women with sickle cell trait. In response to these issues, ASH addressed these concerns via a meeting and letter to the CDC asking for clarification of these guidelines.197 In response, the CDC recently released a written clarification of these guidelines stating that the recommendations were not intended to apply to patients with SCD.197 Recommendation 9 expands on the NHLBI guidelines and puts forth a patient-centered individualized approach for the use of COT in patients with SCD that balances benefits and harms for a given patient. An SCD-specific hospital-based acute care facility may be justifiable if costs are lower and if it can offload ED care. Integral to the overarching theme of these guidelines is the important need to provide individualized interdisciplinary pain management to individuals living with SCD who have acute and chronic pain, because there is no one-size-fits-all approach. Searches for indirect evidence were performed in January 2019. Q10. The greater body of indirect evidence was drawn from the literature in individuals with fibromyalgia and nonspecific low back pain. This variability led the panel to evaluate the evidence for protocols for opioid delivery including time to first dose, individualized dosing, and continuous basal IV opioid infusion as part of patient-controlled analgesia (PCA) during hospitalization. The panel discussed the idea that the cost effectiveness may be hard to fully understand, because the savings from reduced hospitalizations may be offset by increased acute care utilization in the SCD-specific hospital-based acute care facility because of more rapid treatment and reduced stigma. This model would leverage evidence and expertise from the fields of hematology, pain medicine, psychiatry, psychology, nursing, physical therapy, occupational therapy, and other disciplines to help patients achieve maximal function and QOL while minimizing risks and interference from treatment. The systematic review did not identify any direct evidence in patients with SCD that informed this question. Randomized, controlled trials have demonstrated that a twice . This should include a discussion of the theoretical risks of basal opioid infusion and the absence of evidence that addresses the benefits. GRADE evidence to decision frameworks for tests in clinical practice and public health, Guideline panels should seldom make good practice statements: guidance from the GRADE Working Group, AAPT diagnostic criteria for chronic sickle cell disease pain, Headache Classification Committee of the International Headache Society, The International Classification of Headache Disorders, 3rd edition (beta version), Conflict of Interest in Medical Research, Education, and Practice, Considering intellectual, in addition to financial, conflicts of interest proved important in a clinical practice guideline: a descriptive study, The vexing problem of guidelines and conflict of interest: a potential solution, ATS Ethics and Conflict of Interest Committee and the Documents Development and Implementation Committee, An official American Thoracic Society Policy statement: managing conflict of interest in professional societies, GRADE guidelines: 2. In the context of SCD, this interdisciplinary team includes providers from hematology, pain medicine, psychology/psychiatry, emergency medicine, nursing, and physical therapy among others. Because there was an absence of direct evidence, the panel agreed to search the indirect evidence. Penicillins are a group of antibiotics that kill or block the growth of bacteria. Doses >100 mg MME are associated with a ninefold increase in risk of overdose compared with doses <20 mg MME in general non-SCD pain populations. Implementation of the guidelines will be facilitated by forthcoming decision aids. However, the panel agreed that another important clinical matter is the lack of an integrated, evidence-supported multidisciplinary and interdisciplinary treatment model for chronic pain in SCD. The NHLBI guidelines193 used a different approach and adapted recommendations from existing general (ie, not SCD specific) chronic pain management guidelines prepared by the American Pain Society and American Academy of Pain Medicine to patients with SCD. Specifically, the panel discussed the potential for a paradoxical increase in pain perception with these interventions and the risk of harm if these interventions were improperly delivered. The panel identified the following additional areas of research that are needed: (1) delineating the impact that these therapies have on patients in acute pain, because few nonpharmacological therapies have been rigorously evaluated in patients with SCD; (2) evaluating the impact that these nonpharmacological approaches have on important patient-reported health outcomes, such as HRQOL or return to baseline pain; (3) determining if nonpharmacological approaches may be effective for the prevention of acute pain in SCD, the treatment of acute pain when it occurs, and the prevention of the development of chronic pain; and (4) developing protocols that operationalize the delivery of these therapies in the hospital and ambulatory settings. SCD-specific hospital-based acute care facilities tend to be cost effective to the extent that they reduce ED visits and admissions; however, overall acute care utilization may increase. The panel concluded that the intervention would be acceptable to key stakeholders. Should a hospital-based entity such as a day hospital or observation unit compared with regular ED care be used for children and adults with SCD who seek treatment of acute pain? The complete EtD framework for this question, including evidence tables, is provided as an online supplement: https://guidelines.gradepro.org/profile/f4c6c900bf9e6d0e10264fdd1b866f8f. With respect to recommendations for the treatment of chronic pain, unfortunately, the evidence base in SCD directly addressing this serious issue is grossly deficient, and rectifying this should be a high priority for research in the field. Relative to the risks and modest benefits that usual nonoperative care for pain in avascular necrosis of bone offers, the panel concluded that there is reasonable evidence that there will be some patients with SCD and avascular necrosis of bone for which benefits of these interventions will outweigh risks. These evidence-based guidelines developed by the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in pain management decisions for children and adults with SCD. We did not do any further searches than those completed for the guidelines. There were 7 systematic reviews identified in primarily mixed surgical populations using virtual reality,72-75 massage,76 and TENS.77,78 These reviews found significant improvements in pain intensity (massage, TENS, and VR) and significant reductions in opioid use (TENS) and length of stay (TENS). Therefore, providers should make efforts to reduce or eliminate scheduled opioid doses between acute episodic pain events, which may reduce the likelihood of unintentional COT. The condition is characterised by anaemia, episodes of acute painful crisis and an increased risk of infection. This underscores the need for pediatric-specific investigations focused on the impact of therapies for acute and chronic SCD pain. Family physicians and family medical homes are essential to the care of children, adults, and families affected by sickle cell disease (SCD). The panel systematically reviewed and appraised the available evidence to determine how these alternative care delivery models compare with traditional ED care for the management of acute pain. When high-quality evidence was lacking, expert consensus was used to provide recommendations. Audience It is unknown if these harms are the same in individuals with SCD. The panel did not identify any evidence in a systematic review of the evidence for the use of IV fluids in addition to pharmacological management of acute pain. Q3. The panel acknowledges that there was no important uncertainty or variability about how much people value the main outcomes that were considered. The potential benefits of steroid use in acute pain in SCD include decreased length of stay. Doses >100 mg of MME are associated with a ninefold increase in risk of overdose compared with doses <20 mg of MME in general non-SCD pain populations. (SOR: strong, based on low-quality evidence). In children, it often presents with fever and signs of middle lobe lung involvement, whereas adults are often afebrile and have multilobe infiltrates. The risk of adverse events related to COT rises as the total dose increases. High-dose opioids for chronic non-cancer pain: an overview of Cochrane reviews, Opioids for chronic noncancer pain: a systematic review and meta-analysis, The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop, Long-term opioid management for chronic noncancer pain, Opioids for chronic non-cancer pain in children and adolescents, Opioid tolerancea predictor of increased length of stay and higher readmission rates, Opioid dose and risk of road trauma in Canada: a population-based study, Opioid use for noncancer pain and risk of myocardial infarction amongst adults, Opioid use for noncancer pain and risk of fracture in adults: a nested case-control study using the general practice research database, Prescription opioids for back pain and use of medications for erectile dysfunction, Opioid prescriptions for chronic pain and overdose: a cohort study, Opioid dose and drug-related mortality in patients with nonmalignant pain, The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription, The opioid drug epidemic and sickle cell disease: guilt by association, Cohort study of the impact of high-dose opioid analgesics on overdose mortality [published correction appears in, Guidance on opioid tapering in the context of chronic pain: evidence, practical advice and frequently asked questions, Patient-centered prescription opioid tapering in community outpatients with chronic pain, Prescription opioid taper support for outpatients with chronic pain: a randomized controlled trial, Tapering long-term opioid therapy in chronic noncancer pain: evidence and recommendations for everyday practice, Opioid cessation and multidimensional outcomes after interdisciplinary chronic pain treatment, Development and validation of shortened, restructured Treatment Outcomes in Pain Survey instrument (the S-TOPS) for assessment of individual pain patients health-related quality of life, Development and validation of an eight-item brief form of the SOAPP-R (SOAPP-8), Development of a brief version of the Current Opioid Misuse Measure (COMM): the COMM-9, Efficacy of the opioid compliance checklist to monitor chronic pain patients receiving opioid therapy in primary care, Risk factor assessment for problematic use of opioids for chronic pain, Prescription opioid abuse in chronic pain: an updated review of opioid abuse predictors and strategies to curb opioid abuse (part 2), Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia, Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia, Investigators of the Phase 3 Trial of l-Glutamine in Sickle Cell Disease, A phase 3 trial of l-glutamine in sickle cell disease, Crizanlizumab for the prevention of pain crises in sickle cell disease, National Heart, Lung, and Blood Institute Expert Panel. 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