American Pain Society Guidelines Research Articles

Retrospective Review of Perioperative Multimodal Analgesia for Orthopedic Patients in a Veterans Affairs Setting.

To determine adherence of perioperative knee/hip arthroplasties and hip fracture repairs to the American Pain Society (APS) guideline recommendations for perioperative pain control. One secondary objective was to perform an internal quality audit on the use of enhanced recovery after surgery (ERAS) protocols; another secondary objective was to design an evidence-based, multi-modal perioperative quick-order menu (if warranted). A retrospective quality improvement (QI) review of uncomplicated knee/hip replacement and hip fracture repairs from January 2018 through March 2018. West Palm Beach Veterans Affairs Medical Center (WPB VAMC) including acute care, subacute rehabilitation, and outpatient setting. Analgesic use in the perioperative setting via electronic health record review. Forty-seven patients were retrospectively reviewed. Perioperative multi-modal analgesia was used in 85% of patients. Eighty-seven percent were discharged on multi-modal analgesia. There was a 67% response rate to the internal quality audit on ERAS protocol usage from the orthopedic team. A retrospective QI review completed approximately two years after APS guideline publication showed that compliance with these recommendations for multi-modal analgesia (consisting of the use of at least two medication classes) at the WPB VAMC in the postoperative setting for knee/hip arthroplasties and hip fracture repairs was 85%. This indicated potential for improvement in achieving a pharmacologic multimodal and ERAS intervention. The authors developed an evidence-based quick-order menu to further reinforce adherence to the APS perioperative guidelines.

42 Increased narcotic requirements after laparoscopic hysterectomy in patients with history of multiple cesarean deliveries

Complicated laparoscopic hysterectomies may result in increased manipulation of tissue, and potentially lead to suboptimal postoperative pain control. Given that pain in the post-anesthesia care unit (PACU) has been found to be directly associated with overall patient satisfaction, being able to identify what patients are at higher risk for increased pain would allow for preemptive targeted multimodal interventions to reduce postoperative discomfort. One of the most common factors that increases surgical complexity during hysterectomy is history of cesarean deliveries. The objective of this study was to determine if an increased number of prior cesarean deliveries in patients undergoing a laparoscopic hysterectomy resulted in higher narcotic use in the PACU. A retrospective chart review was performed using cases from 4 fellowship trained MIS surgeons with similar operative techniques. Cases from 2018-2020 were reviewed. We included all patients between the ages of 18 and 60 who underwent laparoscopic hysterectomy and received a preoperative para-cervical block. Patients who had concomitant procedures such as pelvic floor repair, interventions for urinary incontinence, or excision of endometriosis were excluded. Data collected included age, body mass index, uterine weight, estimated blood loss, operative time, and total narcotics received in the PACU. Units of narcotics administered were converted to intravenous morphine milligram equivalents (MMEs) based on the American Pain Society guidelines and critical review papers. T-student was used to compare means between groups. There were 77 patients were selected for analysis. Patients were separated into groups depending on whether they had less than 3 (n = 60) or 3 or more (n = 17) cesarean deliveries. There was no difference regarding age (44.16 vs 44.65, P =.78), BMI (33.68 vs. 34.78, P=.53), EBL (65.17 mL vs. 85.88 mL, P=.14), or uterine weight (212.13 g vs. 202.88 g, P=.78). As expected, operating time was higher in the patients with 3 or more cesareans (140.08 min vs. 180.56 min, P<.01). Total narcotic use in the PACU was also significantly higher this group (5.42 MME vs. 10.24 MME, P<.01). These findings suggest that patients undergoing a laparoscopic hysterectomy with history of 3 or more cesarean deliveries are at a risk for higher narcotic requirements in the PACU and are potential targets for further postoperative pain reduction strategies.

72 Post-anesthesia narcotic use in obese patients following minimally invasive hysterectomy

Adequate pain control in the post-anesthesia care unit (PACU) has been directly associated to overall patient satisfaction. Identifying which patients are at increased risk for elevated narcotic use after surgery would allow for targeted multimodal preemptive interventions to reduce the need for narcotics. The objective of this study was to determine if an elevated body mass index (BMI) in patients undergoing laparoscopic hysterectomy increases narcotic requirements in the PACU. A retrospective chart review of all surgical cases between 2018 and 2020 performed by 4 fellowship trained MIS surgeons with similar operative techniques was completed. We included patients who were between 18 and 60 years of age that had undergone a laparoscopic hysterectomy. Patients who received concomitant procedures such as pelvic floor repair, interventions for urinary incontinence, or excision of endometriosis were excluded. Data collected included age, uterine weight, estimated blood loss, operative time, and narcotics received in the PACU. Total dose of administered narcotics was converted to intravenous morphine milligram equivalents (MME) based on the American Pain Society guidelines and critical review papers. T-Student was used to compare means between groups. One hundred eighty-five patients were included for analysis. Patients were divided into 2 groups depending on whether their BMI was less than 30 kg/m2 (n = 60) or equal to or greater than 30 kg/m2 (n = 125). Statistical analysis revealed that the two groups were similar in regards to age (44.48 vs. 43.58, P = 0.38), operative time (170.5 minutes vs. 177.05 minutes, P = 0.46), EBL (91.92 mL vs. 88.88 mL, P = 0.80), and uterine weight (221.6 g vs. 214.9 g, P = 0.80). Total narcotic use in the PACU was significantly higher in the BMI greater than or equal to 30 kg/m2 group at 6.76 MME (SD=6.98) compared to the BMI less than 30 kg/m2 group at 4.15 MME (SD = 5.22) (P = 0.01). These findings suggest that obese patients undergoing laparoscopic hysterectomy are at a risk for increased narcotic requirements in the PACU and are potential targets for further non-narcotic postoperative pain reduction interventions.

Emergency management of SCD pain crises: Current practices and playing variables

Introduction/ObjectivesAcute pain episode is a common reason for patients with sickle cell disease to present to the Emergency Room. This study is designed to assess the role of multiple factors that might affect the time from Emergency Department triage to the administration of the first opiate pain medication and its dosage, to compare current practices with the American Pain Society Guideline for the Management of Acute and Chronic Pain in Sickle-Cell Disease in the Emergency Department. By identifying and recognizing some of the factors that delay or affect the proper dosing of the pain medications, we aim to implement suitable and plausible changes to ensure better emergency care for these sickle cell disease patients. MethodologyThis is a cross-sectional retrospective descriptive study that relied on collecting non-identifiable data from the local Electronic Medical Record to assess for possible relationship between the proposed set of factors/variables and the time to administration of the 1st pain medication and it's dosage. The population in question includes the entire sickle cell disease patients' population (HB-SS, HB-SC, HB-SD, HB-SB+ and HB-SB0) that are under the care of our Pediatric Hematology-Oncology clinic with the age range of 1 day–21 years. The factors include age, gender, pain assessment/scale, time of presentation, mode of arrival, presence or absence of IV access at presentation, and ESI acuity. ResultsThere were 259 patient Emergency Room visits with 148 unique patients. Mean (SD) age of the entire study population was 15.98 (±4.08) years and 61.8% of the patients were females. Average time to 1st opiate pain medication was 120.27 min (SD ± 78.4) and average doses of Morphine and Hydromorphone were 0.067 mg/kg and 0.053 mg/kg respectively. Longer waiting time to 1st opiate pain medication were found in females with a mean difference of 25.5 min (95% CI 20–80.5 P value 0.027), older patients and patients with least severity ESI score (correlation coefficient of 0.214 & 0.134 (p values of 0.001 and 0.031) respectively). On the other hand, there seems to be a negative correlation between the time to 1st opiate and the pain score with a negative correlation coefficient of −0.22 (p value of <0.001). ConclusionOverall, patients with acute SCD pain experienced significant delays when seeking pain relief in the Emergency Department. The following patients experienced the longest delays: those assigned a lower triage priority level, female patients, patients with lower pain score and older patients.

Lumbar Spine X-Ray as a Standard Investigation for all Low back Pain in Ghana: Is It Evidence Based?

Low back pain (LBP) has a prevalence of 84% in Africa. The commonest form of imaging is plain lumbar spine x-ray. It gives a radiation dose equivalent to 65 times a chest x-ray dose and sends one of the highest doses to the human reproductive organs. The commonest cause of LBP in Africa is degenerative disease. X-ray findings do not change mode of treatment yet most physicians still routinely request for x-rays. This is a systematic review of databases including The Cochrane, CINAHL plus, AMED, and MEDLINE. Key evidence was clinical guidelines on x-ray use for low back pain. Key search terms included low back pain, x-rays, guidelines, Ghana. Four clinical guidelines on LBP emerged from two Systematic Reviews rated excellent and four good Randomized Controlled Trials: The European guidelines for acute and sub-acute non-specific Low Back Pain, The American College of Physicians and the American Pain Society guideline for diagnostic imaging for Low Back Pain, The NICE guidelines for persistent non-specific Low Back Pain and the Ghana Standard Treatment Guidelines (GSTG). All the guidelines agree that a good history and clinical examination for all LBP patients helps in diagnosing. Only GSTG recommends routine plain spinal x-rays. There is strong evidence indicating very little benefit from routine lumbar spine x-rays for all LBP. The GSTG needs to be revised considering the increased risks of radiation exposure and the x-ray costs. None declared.

New American Pain Society guideline on postoperative pain

New American Pain Society guideline on postoperative pain

Intraarticular Facet Injections for Low Back Pain: Design Considerations, Consensus Methodology to Develop the Protocol for a Randomized Controlled Trial

Background: Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs). Objectives: To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed. Study Design: A consensus conference involving expert professionals and lay members. Methods: Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to resolve outstanding issues. Results: Fifty-two delegates attended the conference with lay people and all relevant professions represented. Consensus was reached on the details of how to assess patients for facet joint pain, undertake the injections, and deliver usual care. Where post conference checking of results revealed errors in calculating ranking results on the day, consensus was reached by email consultation. All but 3 delegates agreed to be associated with the outcome. Limitations: Allocating one day for discussing a wide range of topics imposed time pressure on discussion and calculation of the numerous rankings. Conclusions: Through the use of an evidence-based, systematic, inclusive, and transparent process we have established consensus from expert health professionals in the UK, with lay input, on the clinical assessment of suspected facet joint pain, interaarticular injection for facet joint pain, and best usual care for use in a feasibility study for a proposed pragmatic clinical trial of interaarticular facet joint injections. This provides a strong basis for a clinical trial that will be acceptable to the pain treatment community. Key words: Low back pain, interaarticular facet joint injections, best usual care, consensus, nominal group technique

Adherence to prescription opioid monitoring guidelines among residents and attending physicians in the primary care setting.

The aim of this study was to compare adherence to opioid prescribing guidelines and potential opioid misuse in patients of resident vs attending physicians. Retrospective cross-sectional study. Large primary care practice at a safety net hospital in New England. Patients 18-89 years old, with at least one visit to the primary care clinic within the past year and were prescribed long-term opioid treatment for chronic noncancer pain. Data were abstracted from the electronic medical record by a trained data analyst through a clinical data warehouse. The primary outcomes were adherence to any one of two American Pain Society Guidelines: (1) documentation of at least one opioid agreement (contract) ever and (2) any urine drug testing in the past year, and evidence of potential prescription misuse defined as ≥2 early refills. We employed logistic regression analysis to assess whether patients' physician status predicts guideline adherence and/or potential opioid misuse. Similar proportions of resident and attending patients had a controlled substance agreement (45.1% of resident patients vs. 42.4% of attending patient, P = 0.47) or urine drug testing (58.6% of resident patients vs. 63.6% of attending patients, P = 0.16). Resident patients were more likely to have two or more early refills in the past year relative to attending patients (42.8% vs. 32.5%; P = 0.004). In the adjusted regression analysis, resident patients were more likely to receive early refills (odds ratio 1.82, 95% confidence interval 1.26-2.62) than attending patients. With some variability, residents and attending physicians were only partly compliant with national guidelines. Residents were more likely to manage patients with a higher likelihood of opioid misuse.

Low Back Pain and Associated Imaging Findings among HIV-Infected Patients Referred to an HIV/Palliative Care Clinic

Low back pain is a common cause of chronic pain in human immunodeficiency virus (HIV)-infected patients. The American College of Physicians and American Pain Society guidelines for diagnostic imaging in low back pain are difficult to apply to patients with chronic illnesses like HIV who may have risk factors for cancer or compression fractures, but whether imaging all such patients for low back pain improves outcomes is unknown. Our objective was to describe patients referred to a chronic pain-focused HIV/palliative care clinic (HPCC) with back pain and their associated lumbar spine imaging findings. We conducted a retrospective chart review of patients at a palliative care clinic that sees patients with HIV, most of whom have chronic pain. Charts with a diagnosis of low back pain were cross-referenced with an imaging database and any magnetic resonance imaging (MRI) of the lumbar spine with or without contrast were identified. Seventy-six of 137 patients referred to the HPCC were found to have back pain. These patients were mainly young (median age 45, interquartile range 40-51) with well-controlled HIV. Twenty-two (29%) of these patients had an MRI of the lumbar spine, and 11 (50%) of these warranted follow-up, most of whom had degenerative disc disease, including four with findings concerning for malignancy. This is the first study to explore the role of spinal imaging in HIV-infected patients. In our study, four patients had findings concerning for malignancy. These findings suggest that spinal imaging should be considered in the work up of HIV-infected patients with moderate to severe back pain.

Taking the Pain out of Pain Management

Residents moving into an assisted living (AL) facility are typically looking for assistance. This is especially true in the area of pain management. From the initial assessment, to the prescribing and filling of a prescription, to the administration of pain medications, the management of pain for AL residents can sometimes be a pain. Along the way, there are many challenges and obstacles that stand in the way of efficient and effective pain management, but an astute nursing staff can ensure that this process provides AL residents the pain relief they need. Pain relief is so critical that the Joint Commission has made it a stated mandate that all individuals have the right to effective pain and symptom management. This mandate is to be included in the delivery of basic clinical nursing care. In addition, the Agency for Healthcare Research and Quality (AHRQ) has asserted that institutions have the responsibility for pain management and that this responsibility begins with the affirmation that individuals should have access to the best level of pain relief that may be safely provided. The American Pain Society developed an early pain-relief quality improvement program. This guideline has been refined and expanded, resulting in a shift from processes to outcomes. Specifically, the American Pain Society Guidelines call for the following:

Guidelines Warfare Over Interventional Techniques: Is There a Lack of Discourse or Straw Man?

Guideline development seems to have lost some of its grounding as a medical science. At their best, guidelines should be a constructive response to assist practicing physicians in applying the exponentially expanding body of medical knowledge. In fact, guideline development seems to be evolving into a cottage industry with multiple, frequently discordant guidance on the same subject. Evidence Based Medicine does not always provide for conclusive opinions. With competing interests of payers, practitioners, health policy makers, and third parties benefiting from development of the guidelines as cost saving measures, guideline preparation has been described as based on pre-possession, vagary, rationalization, or congeniality of conclusion. Beyond legitimate differences in opinions regarding the evidence that could yield different guidelines there are potentials for conflicts of interest and various other issues play a major role in guideline development. As is always the case, conflicts of interest in guideline preparation must be evaluated and considered. Following the development of American Pain Society (APS) guidelines there has been an uproar in interventional pain management communities on various issues related to not only the evidence synthesis, but conflicts of interest. A recent manuscript published by Chou et al, in addition to previous publications appear to have limited clinician involvement in the development of APS guidelines, demonstrates some of these challenges clearly. This manuscript illustrates the deficiencies of Chou et al’s criticisms, and demonstrates their significant conflicts of interest, and use a lack of appropriate evaluations in interventional pain management as a straw man to support their argument. Further, this review will attempt to demonstrate that excessive focus on this straw man has inhibited critique of what we believe to be flaws in the approach. Key words: Guidelines, interventional pain management, professionalism, discourse, disclosure, conflicts of interest, evidence-based medicine, comparative effectiveness research, Patient-Centered Outcomes Research Institute

Can behavioral treatments be enhanced by integrative neuromuscular training in the treatment of juvenile fibromyalgia?

Can behavioral treatments be enhanced by integrative neuromuscular training in the treatment of juvenile fibromyalgia?

Guideline Warfare Over Interventional Therapies for Low Back Pain: Can We Raise the Level of Discourse?

As guidelines proliferate and are used to inform efforts to improve the quality and efficiency of care, disputes over guideline recommendations are likely to become more common and contentious. It is appropriate for guidelines to come under close scrutiny, given their important clinical and policy implications, and critiques that point out missing evidence, improper methods, or errors in interpretation can be valuable. But for critiques to be valid, they should be based on accurate information and a sound scientific basis. A 2009 guideline sponsored by the American Pain Society (APS) on the use of invasive tests and interventional procedures found insufficient evidence to make recommendations for most interventional procedures. It was subsequently the subject of lengthy critiques by the American Society of Interventional Pain Physicians (ASIPP) that sought to challenge the methods used to develop the APS guideline, point out alleged errors in the evidence review commissioned to inform the guideline, and question the integrity of the APS guideline process. We show that the ASIPP critiques contain numerous errors and fail to adhere to scientific standards for reviewing evidence, and provide suggestions on how future disputes regarding guidelines might be addressed in a more constructive manner. Perspective In order to best serve patients and clinicians, debates over guidelines should be based on accurate information, adhere to current methodological standards, acknowledge important deficiencies in the evidence when they are present, and handle conflicts of interest in a vigorous and transparent manner.

Diagnostic Imaging for Low Back Pain: Advice for High-Value Health Care From the American College of Physicians

Diagnostic imaging is indicated for patients with low back pain only if they have severe progressive neurologic deficits or signs or symptoms that suggest a serious or specific underlying condition. In other patients, evidence indicates that routine imaging is not associated with clinically meaningful benefits but can lead to harms. Addressing inefficiencies in diagnostic testing could minimize potential harms to patients and have a large effect on use of resources by reducing both direct and downstream costs. In this area, more testing does not equate to better care. Implementing a selective approach to low back imaging, as suggested by the American College of Physicians and American Pain Society guideline on low back pain, would provide better care to patients, improve outcomes, and reduce costs.

Critiquing the Critiques: The American Pain Society Guideline and the American Society of Interventional Pain Physicians’ Response to It

Critiquing the Critiques: The American Pain Society Guideline and the American Society of Interventional Pain Physicians’ Response to It

A Critical Review of the American Pain Society Clinical Practice Guidelines For Interventional Techniques: Part 2. Therapeutic Interventions

Background: Clinical guidelines are a constructive response to the reality that practicing physicians require assistance in assimilating and applying the exponentially expanding, often contradictory, body of medical knowledge. They attempt to define practices that meet the needs of most patients under most circumstances. Ideally, specific clinical recommendations contained within practice guidelines are systematically developed by expert panels who have access to all the available evidence, have an understanding of the clinical problem, and have clinical experience with the procedure being assessed, as well as knowledge of relevant research methods. The recent development of American Pain Society (APS) guidelines has created substantial controversy because of their perceived lack of objective analysis and recommendations perceived to be biased due to conflicts of interest. Objectives: To formally and carefully assess the APS guidelines’ evidence synthesis for low back pain for therapeutic interventions using the same methodology utilized by the APS authors. The interventions examined were therapeutic interventions for managing low back pain, including epidural injections, adhesiolysis, facet joint interventions, and spinal cord stimulation. Methods: A literature search by 2 authors was carried out utilizing appropriate databases from 1966 through July 2008. Articles in which conflicts arose were reviewed and mediated by a third author to arrive at a consensus. Selections of manuscripts and methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in the APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and their translation into practice recommendations. Results: The conclusions of APS and our critical assessment based on grading of good, fair, and poor, agreed that there is fair evidence for spinal cord stimulation in post lumbar surgery syndrome, and poor evidence for lumbar intraarticular facet joint injections, lumbar interlaminar epidural injections, caudal epidural steroids for conditions other than disc herniation or radiculitis, sacroiliac joint injections, intradiscal electrothermal therapy, endoscopic adhesiolysis, and intrathecal therapy. However, our assessment of APS guidelines for other interventional techniques, utilizing their own criteria, showed fair evidence for therapeutic lumbar facet joint nerve blocks, caudal epidural injections in disc herniation or radiculitis, percutaneous adhesiolysis in post lumbar surgery syndrome, radiofrequency neurotomy, and transforaminal epidural injections in radiculitis. Also it is illustrated that inclusion of latest literature will change the conclusions, with improved grading – caudal epidural, adhesiolysis, and lumbar facet joint nerve blocks from fair to good or poor to fair. The present critical assessment review illustrates that APS guidelines have utilized multiple studies inappropriately and have excluded appropriate studies. Our integrity assessment shows deep concerns that the APS guidelines illustrating significant methodologic failures which raise concerns about transparency, accountability, consistency, and independence. Conclusion: The current reassessment, using appropriate methodology, shows evidence similar to APS guidelines for several procedures, but differs extensively from published APS guidelines for multiple other procedures including caudal epidural injections, lumbar facet joint nerve blocks, lumbar radiofrequency neurotomy, and percutaneous adhesiolysis. Key words: Guidelines, evidence-based medicine, systematic reviews, American Pain Society, interventional pain management, interventional techniques

A Critical Review of the American Pain Society Clinical Practice Guidelines for Interventional Techniques: Part 1. Diagnostic Interventions

Background: Clinical guidelines are defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. The clinical guideline industry has been erupting even faster than innovation in health care, constantly adding unhealthy perspectives with broad and complex mandates to health care interventions. Clinical guidelines are based on evidence-based medicine (EBM) and comparative effectiveness research (CER). Multiple issues related to the development of clinical guidelines are based on conflicts of interest, controversies, and limitations of the guideline process. Recently, the American Pain Society (APS) developed and published multiple guidelines in managing low back pain resulting in multiple publications. However, these guidelines have been questioned regarding their development process, their implementation, and their impact on various specialties. Objectives: To reassess the APS guidelines’ evidence synthesis for low back pain diagnostic interventions using the same methodology utilized by the APS authors. The interventions examined were diagnostic techniques for managing low back pain of facet joint origin, discogenic origin, and sacroiliac joint origin. Methods: A literature search by two authors was carried out utilizing appropriate databases from 1966 through July 2008. Methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and the translation into practice recommendations. Results: Our reassessment of Chou et al’s evaluation, utilizing Chou et al’s criteria, showed good evidence for lumbar facet joint nerve blocks, fair evidence for lumbar provocation discography, and fair to poor evidence for sacroiliac joint blocks to diagnose sacroiliac joint pain. The reassessment illustrates that Chou et al have utilized multiple studies inappropriately and have excluded appropriate studies. Also, Chou et al failed to eliminate their bias in their study evaluations. Conclusion: The reassessment, using appropriate methodology and including high quality studies, shows evidence that differs from published APS guidelines. Key words: Guidelines, evidence-based medicine, comparative effectiveness research, systematic reviews, American Pain Society, interventional pain management, interventional techniques, low back pain, diagnostic interventions, lumbar facet joint nerve blocks, lumbar provocation discography, sacroiliac joint nerve blocks

Opioid-sparing properties of intranasal ketorolac: a pooled analysis of patients experiencing moderate-to-severe acute pain

Ketorolac is a nonopioid mixed COX1/2 inhibitor used for short-term (up to 5 days) management of moderate-to-severe acute pain. An intranasal (IN) formulation of ketorolac is in development as a self-administered alternative to injectable ketorolac and opioids for pain management. The pharmacokinetics of IN ketorolac are similar to those of ketorolac administered intramuscularly. The efficacy and tolerability of IN ketorolac were assessed in phase 2/3 clinical trials in 705 patients (men and women, ≥18 yr). Abdominal and orthopedic surgery models were used to assess IN ketorolac efficacy in managing moderate-to-severe acute pain. Patients received IN ketorolac (31.5 mg) (n=455) or placebo (n=250) 3 or 4 times a day for up to 5 days. Statistically significantly greater reductions in the summed pain intensity difference over 48 hr occurred in patients receiving IN ketorolac compared to placebo (P<0.05). The most common adverse events in the IN ketorolac group were transient nasal discomfort (15% vs. 2% placebo) and rhinalgia (12% vs <1% placebo). Most patients received concurrent opioid analgesics for the first 48 hr. Morphine use (mg) was calculated by adding all PCA morphine and morphine equivalents (using American Pain Society guidelines for other analgesic medications). Patients in the IN ketorolac group used 34% less morphine over 48 hours after surgery compared to the placebo group (P<0.001). In the first 8 hr after surgery, patients receiving IN ketorolac undergoing orthopedic surgery had greater decreases in opioid use relative to placebo than did abdominal surgery patients. Reductions in opioid use were similar when stratified by age and sex. Efficacy in this clinical model indicates that IN ketorolac provides a noninjection parenteral option for management of acute moderate-to-severe pain that may be particularly useful for ambulatory patients, particularly where avoidance of, or reductions in, opioid use are desirable. (Supported by ROXRO PHARMA). Ketorolac is a nonopioid mixed COX1/2 inhibitor used for short-term (up to 5 days) management of moderate-to-severe acute pain. An intranasal (IN) formulation of ketorolac is in development as a self-administered alternative to injectable ketorolac and opioids for pain management. The pharmacokinetics of IN ketorolac are similar to those of ketorolac administered intramuscularly. The efficacy and tolerability of IN ketorolac were assessed in phase 2/3 clinical trials in 705 patients (men and women, ≥18 yr). Abdominal and orthopedic surgery models were used to assess IN ketorolac efficacy in managing moderate-to-severe acute pain. Patients received IN ketorolac (31.5 mg) (n=455) or placebo (n=250) 3 or 4 times a day for up to 5 days. Statistically significantly greater reductions in the summed pain intensity difference over 48 hr occurred in patients receiving IN ketorolac compared to placebo (P<0.05). The most common adverse events in the IN ketorolac group were transient nasal discomfort (15% vs. 2% placebo) and rhinalgia (12% vs <1% placebo). Most patients received concurrent opioid analgesics for the first 48 hr. Morphine use (mg) was calculated by adding all PCA morphine and morphine equivalents (using American Pain Society guidelines for other analgesic medications). Patients in the IN ketorolac group used 34% less morphine over 48 hours after surgery compared to the placebo group (P<0.001). In the first 8 hr after surgery, patients receiving IN ketorolac undergoing orthopedic surgery had greater decreases in opioid use relative to placebo than did abdominal surgery patients. Reductions in opioid use were similar when stratified by age and sex. Efficacy in this clinical model indicates that IN ketorolac provides a noninjection parenteral option for management of acute moderate-to-severe pain that may be particularly useful for ambulatory patients, particularly where avoidance of, or reductions in, opioid use are desirable. (Supported by ROXRO PHARMA).

Fibromialgia - Que abordagem terapêutica?

Objectives: To identify the most recommended non-pharmacological and pharmacological treatments for fi bromyalgia based on the level of scientific evidence. Data Source and Review Methods: Literature review in Medline, through PubMed and Medscape, specialized textbook and support literature from congresses consult; between 2005 and 2008. Results: Based on inclusion criteria, selection was made of two guidelines, two systematic review articles and three evidence based review articles. The growing number of studies originates new scientific evidence concerning the therapeutic approach of this disease. The American Pain Society guidelines (2005) highlight diagnostic confirmation, patient education and comorbidities evaluation and treatment. The European League against Rheumatism guidelines (2007) also considers the importance of all comorbidities and symptoms characteristics and intensity when deciding the initial treatment. The Americans defend, as first line the rapy, tricyclic antidepressants and cyclobenzaprine. However, more recent studies confirm the higher efficacy of selective serotonin and norepinephrine reup take inhibitors as well as the alfa2deltaligands-pregabalin, the latter being preferred when the clinicalpicture is dominated by sleep disturbances and anxiety. The absence of a clinical response to monotherapy should bring to consideration the association of these two approaches. Both guidelines consider analgesics and anti-inflammatory drugs as a second line pharmacological treatment. Concerning non-pharmacological treatment, both guidelines recommend physical exercise and cognitive-behavioural the rapy. The combination of pharmacological and non-pharmacological treatment as a part of a multidisciplinary approach should always be the first option, having in mind each individual case. Conclusion: Fibromyalgia implies a high cost in health resources. Therefore it should be approached considering the individual as a bio-psycho-social unit, and be faced as a reality, regarding recent studies. More investigation should be made to better understand the physiopathology of this disease. Only a better comprehension of fibromyalgia will allow the development of newer and more adapted therapeutic options.

Comparison of Health Care Use and Costs in Newly Diagnosed and Established Patients With Fibromyalgia

In 2004, the American Pain Society (APS) issued evidence-based fibromyalgia treatment recommendations. The objective of this claims database analysis is to describe prescription and medical use in patients with newly diagnosed and established fibromyalgia. Privately insured patients with 2+ myalgia/myositis claims (1999 to 2005) were categorized as newly diagnosed or established; this dichotomy involves comparisons between prediagnosis (S1) and postdiagnosis (S2) stages in the newly diagnosed and between newly diagnosed (S2) and established patients (S3). Use of APS guideline medications increased across stages: selective serotonin reuptake inhibitors (SSRIs) (S1, S2, S3: 20.6%, 22.9%, 25.3%), serotonin norepinephrine reuptake inhibitors (SNRIs) (4.5%, 6.4%, 8.9%), pregabalin/gabapentin (5.4%, 7.4%, 8.8%), benzodiazepines (19.0%, 21.1%, 24.2%), non-benzodiazepine sedatives (9.1%, 11.5%, 13.7%) (all P < .0001), and opioids (39.5%, 43.3%, 43.9%; S1 vs S2, P < .0001; S2 vs S3, P = .2835). Use of multiple therapeutic classes also increased across stages: 3+ classes (7.1%, 9.6%, 11.8%) (all P < .0001). Office visits to providers increased, on average, after diagnosis: primary care (70.9%, 78.3%, 76.3%; all P < .0001), chiropractors (28.8%, 51.1%, 53.3%; all P < .0001), rheumatologists (4.2%, 9.9%, 10.5%; S1 vs S2, P < .0001; S2 vs S3, P = .0595), mental health (6.4%, 7.3%, 8.3%; S1 vs S2, P < .0001, S2 vs S3, P = .0003). Average health care costs rose after diagnosis in the newly diagnosed group (S1: $6555 vs S2: $8654, P < .0001). This paper investigates prescription drug and medical care use with respect to stages of fibromyalgia diagnosis. Established fibromyalgia patients use more medical resources and have higher rates of concomitant medication use than newly diagnosed fibromyalgia patients. Findings can help educate providers regarding optimal drug treatment patterns in this population.