American Academy Of Pain Medicine Research Articles

A survey of pain physicians: Needlesticks injuries.

To investigate and characterize the incidence of needlestick injuries (NSI) in a sample of practicing pain medicine physicians, with the ultimate goal of aiding to prevent these injuries by raising awareness of their prevalence. A cross-sectional research survey. A REDCap survey was emailed to physicians who had membership to the American Academy of Pain Medicine. Eligibility criteria included physicians who were actively practicing and identified as pain physicians who participated in procedures with needlesticks or sharps. Basic demographics without identifiers were collected, including practice setting, years in practice, and training type. Respondents were asked to estimate the number of sharps-involved procedure days per week and per day. They were then asked to estimate the number of NSIs they sustained since completing training and in the past year. A total of 430 surveys were opened by email by potential participants, of which 124 responded (response rate 29%). Data from a total of 109 respondents that met inclusion criteria were included. Roughly 60% of respondents reported at least one NSI since completing training and approximately one-third had sustained more than three NSIs. In the last year, roughly 19% of providers reported at least one needlestick injury. The number of NSIs reported by providers since completing training was not significantly associated with practice setting, the number of procedure days per week, or the number of sharps-involved procedures per day. There was a significant relationship between years post-training and number of NSIs since completing training, with providers with more years post-training reporting higher incidences of NSIs (p < 0.0005). The number of NSIs since completing training and the number of NSIs were also associated, with providers that had sustained a greater number of total NSIs reporting a higher incidence of NSIs within the last year (p < 0.0005). This study characterizes NSIs in a population of pain medicine physicians. These data warrant caution and will hopefully raise awareness amongst providers.

Best practices for interventional pain procedures in the setting of a local anesthetic shortage: A practice advisory from the Spine Intervention Society

Representatives from the Spine Intervention Society (SIS) Standards Division and Evidence Analysis Committee have developed the following best practice recommendations for the performance of interventional pain procedures in the setting of a local anesthetic shortage. The practice advisory has been endorsed by SIS, the American Academy of Pain Medicine, the American College of Radiology, the American Society of Neuroradiology, the American Society of Spine Radiology, the North American Neuromodulation Society, the North American Spine Society, and the Society of Interventional Radiology, who support the following best practice recommendations and statements for the performance of intra-articular, extra-articular, paraspinal, and epidural injections in the setting of a local anesthetic shortage.1.Use of preservative-containing local anesthetics is discouraged in the performance of neuraxial procedures where the injectate may enter the epidural (or intrathecal) spaces.2.When performing procedures with risk of arterial injection, ropivacaine should not be mixed with dexamethasone and injected due to the risk of crystallization and embolization.3.Physicians should not withdraw directly from vials of local anesthetic for multiple patients due to infection risk as per Centers for Disease Control and Prevention (CDC) and Joint Commission guidelines [1].4.Only pharmacists may repackage local anesthetic vials for multiple patients. This must be performed under strict, sterile conditions and only in times of critical need. In such situations, physicians must adhere to the beyond-use-date and storage conditions on the repackaged label [2,3].5.Joint, tendon, bursa, and/or ligament injections may be performed with local anesthetic with or without preservative.6.Interventional pain physicians should weigh the relative chondrotoxicity risks associated with each anesthetic when performing joint injections.7.Topical anesthetics, infiltration with diphenhydramine, and nonpharmacologic therapies (i.e., cognitive behavioral therapy, guided imagery, virtual reality, mechanodesensitization) may be used as alternatives to skin infiltration of local anesthetic for reducing procedural pain.8.Use of small-gauge needles (25 gauge or thinner) mitigates the need for local anesthetic prior to needle insertion.9.For local anesthetic infiltration prior to insertion of large bore needles or incision, 0.5% lidocaine may be as effective as 1%, and for that reason current supplies of lidocaine can be stretched by dilution with normal saline.10.If using an ester local anesthetic due to an amide local anesthetic shortage, interventional pain physicians should be aware (as always) of the potential for an allergic reaction and should be able to respond accordingly.11.Local anesthetic systemic toxicity (LAST) differs between the varying local anesthetics, and interventional pain physicians should be well acquainted with these differences when switching between local anesthetics.Physicians should carefully weigh the risks and benefits of performing procedures without local anesthetic or using an alternative agent in the context of each unique patient's situation and should involve patients in shared decision making before proceeding.Procedures should be performed following Spine Intervention Society Guidelines [4]. The physician should confirm placement of the needle in at least two imaging planes. Please refer to the SIS Practice Guidelines for the full details and standards related to each unique procedure [4].

Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks−American Pain Society−American Academy of Pain Medicine Pain Taxonomy Diagnostic Criteria for Acute Needle Pain

Needle procedures are among the most common causes of pain and distress for individuals seeking health care. While needle pain is especially problematic for children needle pain and associated fear also has significant impact on adults and can lead to avoidance of appropriate medical care. Currently there is not a standard definition of needle pain. A taxonomy, or classification system, for acute needle pain would aid research efforts and enhance clinical care. To meet this need, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public−private partnership with the U.S. Food and Drug Administration, the American Pain Society, and the American Academy of Pain Medicine formed the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks−American Pain Society−American Academy of Pain Medicine Pain Taxonomy initiative. One of the goals of this initiative was to develop taxonomies for acute pain disorders, including needle pain. To accomplish this, a working group of experts in needle pain was convened. Based on available literature and expert opinion, the working group used a 5-dimenional structure (diagnostic criteria, common features, modulating factors, impact and/or functional consequences, and putative mechanisms) to develop an acute pain taxonomy that is specific needle pain. As part of this, a set of 4 diagnostic criteria, with 2 modifiers to account for the influence of needle associated fear, are proposed to define the types of acute needle pain. PerspectiveThis article presents a taxonomy for acute needle pain. This taxonomy could help to standardize definitions of acute pain in clinical studies of patients undergoing needle procedures.

Editorial introductions.

Current Opinion in Anesthesiology was launched in 1988. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The fields of anesthesiology is divided into 16 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Anthony AbsalomAnthony AbsalomProf. Anthony Absalom studied medicine at the University of Cape Town, South Africa, and underwent specialist training in East Anglia and Scotland in the UK. He is currently Professor of Anaesthesiology at the University Medical Center Groningen, Netherlands. His clinical interests are procedural sedation, anaesthesia for neurosurgery, and intravenous anaesthesia techniques. His research interests are mostly in the domains of pharmacology and neuroscience. He is an editor of the British Journal of Anaesthesia, past President of the Society for Intravenous Anaesthesia, and a former vice-president of the World Society for Intravenous Anaesthesia. He is currently Chairman of the Neuroanaesthesia Section of the Dutch Association of Anaesthetists and past-Chair of the General Anaesthesia Scientific Sub-committee of the European Society of Anesthesiology. Ellen SoffinEllen SoffinEllen M. Soffin, MD, PhD is an Associate Professor of Anesthesiology, Weill Cornell Medical College, New York, USA and an anesthesiologist at Hospital for Special Surgery, New York, USA. She is the Director of the Anesthesia-Spine Service, and Co-Director of the Hospital for Special Surgery's interdisciplinary spine research program. Dr Soffin earned her medical degree at King's College Medical School, London, UK and PhD in neuroscience at Edinburgh University, Edinburgh, UK, before moving to the United States. She completed residency training in anesthesiology at The Johns Hopkins Hospital, Baltimore, Maryland, USA and a fellowship in regional anesthesia and acute pain medicine at Hospital for Special Surgery. Dr Soffin's research interests include evaluating the role and value of field and fascial plane blocks for the spine surgery patient; optimizing surgical outcomes using enhanced recovery pathways for total joint arthroplasty and spine surgery; and implementation of regulatory, institutional, and clinical strategies for opioid stewardship programs. She has published extensively on outcomes related to pathway-based care, regional analgesia techniques, and opioid-minimizing approaches to the perioperative care of the orthopedic surgery patient. Dr Soffin serves on the editorial board of Regional Anesthesia & Pain Medicine and is the Section Editor, Acute Pain and Perioperative Care, for Journal of Pain Research. She is an active faculty member of American Society of Regional Anesthesia & Pain Medicine, the American Academy of Pain Medicine, and the Society of Anesthesia & Sleep Medicine, where she is the co-chair of the research committee.

Chronic Opioid Use and Sleep Disorders.

Opioid medications are considered a significant component in the multidisciplinary management of chronic pain. In the past twodecades, the use of opioid medications has dramatically risen in part because of an increased awareness by health care providers to treat chronic pain more effectively. In addition, patients are encouraged to seek treatment. The release of a sentinel joint statement in 1997 by the American Academy of Pain Medicine and the American Pain Society in a national effort to increase awareness and support the treatment of chronic pain has undoubtedly contributed to the opioid crisis.

Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group.

BackgroundThe past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial.MethodsIn August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4–5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement.ResultsTwenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation.ConclusionsCervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.

Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group

BackgroundThe past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet...

Buprenorphine management in the perioperative period: educational review and recommendations from a multisociety expert panel

BackgroundThe past two decades have witnessed an epidemic of opioid use disorder (OUD) in the USA, resulting in catastrophic loss of life secondary to opioid overdoses. Medication treatment of opioid...

Survey of Pain Medicine Specialists' Familiarity with Migraine Management.

Pain specialists treat patients with headache and interface with those who use opioids more so than neurologists and headache specialists. We assessed the headache medicine knowledge and needs of pain specialists. Cross-sectional online survey. Members of the American Academy of Pain Medicine. Survey was based on a prior survey of primary care providers' knowledge and needs and was iteratively updated by four headache specialists, two with pain medicine affiliations. Of the 105 respondents, 71.4% were physicians, 34.3% were women, and they averaged 20.0 ± 13.6 years in practice. The most common specialty was anesthesia (36.1%, n = 35/97) followed by neurology (14.4%, n = 14/97). About half of providers (55.7%, n = 34/61 and 53.3%, n = 32/60) were familiar with the American Academy of Neurology Guidelines for pharmacological migraine prevention and the Choosing Wisely Campaign recommendations for limiting neuroimaging and opioids. Less than half of all providers (39.7%, n = 23/58) were familiar with the American Headache Society guidelines for emergency management of migraine. Providers were aware of Level A evidence-based nonpharmacological therapies, with over three-fourths recognizing cognitive behavioral therapy (80.7%, n = 50/62) and biofeedback (75.8%, n = 47/62) as evidence-based interventions. About 80% of providers (n = 50/64) estimate making migraine diagnoses in ≤50% of their patients with headache. Providers consider starting preventive headache therapy at 7.1 ± 3.9 days/month and report referring 34.3%±34.2% of patients to behavioral interventions. Dissemination and implementation of headache guidelines is needed for pain medicine specialists. Providers may need help diagnosing migraine based on currently accepted guidelines and referring for evidence-based behavioral therapies.

Editors' Note: Characterizing Opioid Use in a US Population With Migraine: Results From the CaMEO Study

Editors' Note: Characterizing Opioid Use in a US Population With Migraine: Results From the CaMEO Study

AAAPT: Assessment of the Acute Pain Trajectory.

ObjectiveDefine and contrast acute pain trajectories vs. the aggregate pain measurements, summarize appropriate linear and nonlinear statistical analyses for pain trajectories at the patient level, and present methods to classify individual pain trajectories. Clinical applications of acute pain trajectories are also discussed.SettingIn 2016, an expert panel involving the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), American Pain Society (APS), and American Academy of Pain Medicine (AAPM) established an initiative to create a pain taxonomy, named the ACTTION-APS-AAPM Pain Taxonomy (AAAPT), for the multidimensional classification of acute pain. The AAAPT panel commissioned the present report to provide further details on analysis of the individual acute pain trajectory as an important component of comprehensive pain assessment.MethodsLinear mixed models and nonlinear models (e.g., regression splines and polynomial models) can be applied to analyze the acute pain trajectory. Alternatively, methods for classifying individual pain trajectories (e.g., using the 50% confidence interval of the random slope approach or using latent class analyses) can be applied in the clinical context to identify different trajectories of resolving pain (e.g., rapid reduction or slow reduction) or persisting pain. Each approach has advantages and disadvantages that may guide selection. Assessment of the acute pain trajectory may guide treatment and tailoring to anticipated symptom recovery. The acute pain trajectory can also serve as a treatment outcome measure, informing further management.ConclusionsApplication of trajectory approaches to acute pain assessments enables more comprehensive measurement of acute pain, which forms the cornerstone of accurate classification and treatment of pain.

Radiation safety and knowledge: an international survey of 708 interventional pain physicians

IntroductionInterventional pain procedures have increased in complexity, often requiring longer radiation exposure times and subsequently higher doses. The practicing physician requires an in-depth knowledge and evidence-based knowledge of radiation safety...

AAAPT Diagnostic Criteria for Acute Neuropathic Pain.

Acute neuropathic pain is a significant diagnostic challenge, and it is closely related to our understanding of both acute pain and neuropathic pain. Diagnostic criteria for acute neuropathic pain should reflect our mechanistic understanding and provide a framework for research on and treatment of these complex pain conditions. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the U.S. Food and Drug Administration (FDA), the American Pain Society (APS), and the American Academy of Pain Medicine (AAPM) collaborated to develop the ACTTION-APS-AAPM Pain Taxonomy (AAAPT) for acute pain. A working group of experts in research and clinical management of neuropathic pain was convened. Group members used literature review and expert opinion to develop diagnostic criteria for acute neuropathic pain, as well as three specific examples of acute neuropathic pain conditions, using the five dimensions of the AAAPT classification of acute pain. AAAPT diagnostic criteria for acute neuropathic pain are presented. Application of these criteria to three specific conditions (pain related to herpes zoster, chemotherapy, and limb amputation) illustrates the spectrum of acute neuropathic pain and highlights unique features of each condition. The proposed AAAPT diagnostic criteria for acute neuropathic pain can be applied to various acute neuropathic pain conditions. Both the general and condition-specific criteria may guide future research, assessment, and management of acute neuropathic pain.

Acute Pain Medicine American Academy of Pain Medicine

Acute Pain Medicine American Academy of Pain Medicine

AAAPT Diagnostic Criteria for Acute Knee Arthroplasty Pain.

The relationship between preexisting osteoarthritic pain and subsequent post-total knee arthroplasty (TKA) pain is not well defined. This knowledge gap makes diagnosis of post-TKA pain and development of management plans difficult and may impair future investigations on personalized care. Therefore, a set of diagnostic criteria for identification of acute post-TKA pain would inform standardized management and facilitate future research. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA), the American Pain Society (APS), and the American Academy of Pain Medicine (AAPM) formed the ACTTION-APS-AAPM Pain Taxonomy (AAAPT) initiative to address this goal. A multidisciplinary work group of pain experts was invited to conceive diagnostic criteria and dimensions of acute post-TKA pain. The working group used contemporary literature combined with expert opinion to generate a five-dimensional taxonomical structure based upon the AAAPT framework (i.e., core diagnostic criteria, common features, modulating factors, impact/functional consequences, and putative mechanisms) that characterizes acute post-TKA pain. The diagnostic criteria created are proposed to define the nature of acute pain observed in patients following TKA.

Finally: An Effective Way of Regenerating Nerves Damaged by Neuropathy

Robert Odell* Author Affiliations Diplomat, American Board of Anesthesiology, American Academy of Pain Medicine, Fellow of Interventional Pain Practice, USA Received: November 05, 2019 | Published: November 14, 2019 Corresponding author: Robert Odell, Diplomat, American Board of Anesthesiology, American Academy of Pain Medicine, Fellow of Interventional Pain Practice, USAnts DOI: 10.26717/BJSTR.2019.22.003815

AAAPT Diagnostic Criteria for Acute Pain Following Breast Surgery

Acute pain after breast surgery decreases the quality of life of cancer survivors. Previous studies using a variety of definitions and methods report prevalence rates between 10% and 80%, which suggests the need for a comprehensive framework that can be used to guide assessment of acute pain and pain-related outcomes after breast surgery. A multidisciplinary task force with clinical and research expertise performed a focused review and synthesis and applied the 5 dimensional framework of the AAAPT (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks [ACTTION], American Academy of Pain Medicine [AAPM], American Pain Society [APS] Pain Taxonomy) to acute pain after breast surgery. Application of the AAAPT taxonomy yielded the following: 1) Core Criteria: Location, timing, severity, and impact of breast surgery pain were defined; 2) Common Features: Character and expected trajectories were established in relevant surgical subgroups, and common pain assessment tools for acute breast surgery pain identified; 3) Modulating Factors: Biological, psychological, and social factors that modulate interindividual variability were delineated; 4) Impact/Functional Consequences: Domains of impact were outlined and defined; 5) Neurobiologic Mechanisms: Putative mechanisms were specified ranging from nerve injury, inflammation, peripheral and central sensitization, to affective and social processing of pain. PerspectiveThe AAAPT provides a framework to define and guide improved assessment of acute pain after breast surgery, which will enhance generalizability of results across studies and facilitate meta-analyses and studies of interindividual variation, and underlying mechanism. It will allow researchers and clinicians to better compare between treatments, across institutions, and with other types of acute pain.

The Use of Ketamine for the Management of Acute Pain in the Emergency Department.

Ketamine has been used as an anesthetic agent for over 50 years. At the upper end of the dosing range, it displays dissociative anesthetic and amnestic effects, while at lower doses, it acts as an analgesic and demonstrates opioid-sparing capabilities. Ketamine is unique in its preservation of hemodynamic stability and respiratory function, and is used extensively in the emergency department (ED) for procedural sedation and the facilitation of brief painful procedures. Despite evidence supporting its safety and efficacy as an analgesic agent at sub-dissociative doses, its use in the ED for the management of acute pain remains uncommon. New guidelines were published in July 2018 by the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists that provide a framework for identifying patients who are likely to benefit from the use of Ketamine in an acute pain setting.

Briefly Noted

Alcoholism & Drug Abuse WeeklyVolume 30, Issue 44 p. 7-8 Briefly Noted Briefly Noted First published: 16 November 2018 https://doi.org/10.1002/adaw.32179Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract The American Medical Association (AMA) has pushed back against the movement to arbitrarily restrict opioids for pain management. The AMA's House of Delegates last week approved a resolution that praised the federal Centers for Disease Control and Prevention (CDC) for “its efforts to prevent incidence of new cases of opioid misuse, addiction, and overdose deaths,” but also urged the AMA to argue against putting blanket limits on the amount and dosage of opioids that physicians can prescribe. “This is a recognition that there are many patients we deal with daily who are outside the norms proffered by the CDC guidelines,” said Bob Wailes, M.D., of Rancho Santa Fe, California, an AMA delegate for the American Academy of Pain Medicine. “The gist of this proposal is that the CDC guidelines have gone way too far and have been used as strict legislative and pharmacy benefit limitations…. We need to recognize by policy that there are patients who fall outside the guidelines.” Frank Dowling, M.D., a delegate for the Medical Society of the State of New York, said “the AMA Opioid Task Force has discussed these issues extensively,” adding “We're getting feedback from physicians around the state … with physicians being punished, prescriptions not being filled, and patients left without medications.” Delegates also passed a provision affirming that some patients benefit from taking higher doses than suggested by the CDC guidelines. “As family physicians, we strongly believe in patient-centered care,” said Romero Santiago, M.D., MPH, of Sacramento, a resident delegate for the American Academy of Family Physicians, who spoke in favor of a provision that would ban standards on morphine milligram equivalents. “It's important to advocate for the needs of our patients.” The CDC guidelines were only guidelines and are not expected to be codified into actual practice. However, they were, at least to the extent of physicians dropping out of pain treatment out of fear of losing their licenses. Having the support of the AMA for these physicians is viewed as a huge game-changer, especially by the extremely vocal pain patient community. Volume30, Issue4419 November 2018Pages 7-8 RelatedInformation

Med Check

Back to table of contents Previous article Next article Clinical and Research NewsFull AccessMed CheckNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:3 Aug 2018https://doi.org/10.1176/appi.pn.2018.8a3FDA Panel Rejects Abuse-Deterrent Oxycodone FormulationParticipants in a joint meeting of the Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee in June voted 14-3 not to recommend the approval of Remoxy ER (oxydone extended-release capsules) for the management of severe pain. Remoxy ER, made by Pain Therapeutics Inc., is a high-viscosity gel formulation designed to keep people from being able to cut, grate, or inject the drug. Some committee members suggested that data presented on the efficacy, safety, and risk-benefit profile of Remoxy ER did not support approval of its application, especially regarding claims of abuse deterrence.Sage Announces Expedited Development Plan for Depression MedicationSage Therapeutics in June announced its expedited development plan for its lead compound SAGE-217 following a meeting with the FDA. SAGE-217, a drug that targets the GABA-A receptor, received FDA breakthrough status in February for the treatment of major depressive disorder (MDD).The new plan includes expedited approval pathways for SAGE-217 for both MDD and postpartum depression (PPD). An ongoing phase 2 study comparing depressive symptoms in women with PPD who receive either 30 mg SAGE-217 or placebo for two weeks was confirmed as appropriate to support registration for PPD, the company noted. The FDA also requested n additional phase 3 trial for MDD. The trial will compare outcomes in 450 patients who take SAGE-217 (20 mg or 30 mg) or placebo for two weeks. Sage will also begin a one-year open-label study of patients with major depression to acquire additional safety data and evaluate the long-term effectiveness of two weeks of SAGE-217 for recurrent major depressive episodes. Saladax Signs Agreement to License Blood Tests For Antipsychotic LevelsIn June, the diagnostics company Saladax Biomedical Inc. signed a license agreement with Janssen Pharmaceutical NV—one of the Janssen Pharmaceutical companies—to acquire exclusive patent rights for diagnostic blood tests that can determine drug levels in patients undergoing treatment with antipsychotic medications. “This intellectual property, along with the existing patents that Saladax already owns, places Saladax in a predominant position in the field of antipsychotic drug testing,” according to a press release by the company. Saladax in March received approval to sell two of its diagnostic tests on the European market: the MyCare Total Risperidone Assay Kit and MyCare Paliperidone Assay Kit. The company has four additional tests for aripiprazole, clozapine, olanzapine, and quetiapine that it expects will receive European clearance later this year. Saladax stated the company will soon seek FDA clearance for these tests as well. Guidelines Released For Use of Ketamine to Treat Acute PainThe American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine, and American Society of Anesthesiologists recently joined together to develop consensus guidelines on the use of intravenous ketamine to treat both chronic and acute pain.These guidelines, published in the journal Regional Anesthesia and Pain Medicine in June, cover a range of scenarios, but broadly state that moderate evidence supports the use of ketamine for acute pain management following painful surgeries, including in people who are opioid dependent. There is also moderate evidence that ketamine works for chronic spinal pain and complex regional pain syndrome. There is limited evidence to support ketamine for other types of chronic or acute pain. The guidelines noted that ketamine should be avoided in people with poorly controlled cardiovascular disease, those with active psychosis, and pregnant women. ■Schwenk, ES et al. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018;43(5):456-466. ISSUES NewArchived