ASPMN Position Statement: Authorized Agent Controlled Analgesia.

The American Society for Pain Management Nursing (ASPMN) has reviewed and updated its position statement on the use of authorized agent controlled analgesia (AACA) for patients who are unable to independently utilize a self-dosing analgesic infusion pump, commonly known as patient-controlled analgesia (PCA). ASPMN continues to support the use of AACA to provide timely and effective pain management while promoting equitable care for vulnerable patient populations who are unable to use PCA. ASPMN does not support the use of "PCA by Proxy" in which unauthorized individuals activate PCA for a patient. This position statement includes an updated review of the evidence related to AACA. Clinical practice recommendations for authorized agents, nurses, prescribers, and organizations are provided with an emphasis on the importance of appropriate authorized agent selection, education, diligent patient assessment and medication management.

Pain Management in Children: NSAID Use in the Perioperative and Emergency Department Settings.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are often used for pediatric pain management in the emergency setting and postoperatively. This narrative literature review evaluates pain relief, opioid requirements, and adverse effects associated with NSAID use. A PubMed search was conducted to identify randomized controlled trials evaluating the use of conventional systemic NSAIDs as pain management for children in the perioperative or emergency department (traumatic injury) setting. Trials of cyclooxygenase-2 inhibitors ("coxibs") were excluded. Search results included studies of ibuprofen (n = 12), ketoprofen (n = 5), ketorolac (n = 6), and diclofenac (n = 4). NSAIDs reduced the opioid requirement in 10 of 13 studies in which this outcome was measured. NSAID use did not compromise pain relief; NSAIDs provided improved or similar pain scores compared with opioids (or other control) in 24 of 27 studies. Adverse event frequencies were reported in 26 studies; adverse event frequencies with NSAIDs were lower than with opioids (or other control) in three of 26 studies, similar in 21 of 26 studies, and more frequent in two of 26 studies. Perioperative and emergency department use of NSAIDs may reduce opioid requirements while maintaining pain control, with similar or reduced frequencies of opioid-associated adverse events.

American Society for Pain Management Nursing Guidelines on Monitoring for Opioid-Induced Advancing Sedation and Respiratory Depression: Revisions.

OBJECTIVES: This report presents up-to-date evidence and expert consensus-based revisions to the ASPMN 2011 guidelines that inform interprofessional clinical decision-making for hospitalized adults receiving opioid analgesics. DESIGN: Systematic review of the literature. METHODS: A 14-member expert panel was charged with reviewing and grading the strength of scientific evidence published in peer reviewed journals and revising the ASPMN 2011 existing guidelines. Panel members formulated recommendations based on the strength of evidence and reached consensus through discussion, reappraisal of evidence, and voting by majority when necessary. The American Society of Anesthesiologists evidence categories for grading and classifying the strength of the evidence were used. Recommendations were subjected to a critical review by ASPMN members as well as external reviews. RESULTS: The 2011 guidelines were found to still be relevant to clinical practice, but new evidence substantiated refinement and more specific recommendations for electronic monitoring. The revised guidelines present risk factors divided into three categories: patient-specific, treatment-related, and environment of care. Specific recommendations for the use of electronic monitoring are delineated. CONCLUSIONS: All hospitalized patients that are administered opioids for acute pain are at risk of opioid induced advancing sedation and respiratory depression, but some patients are at high risk and require extra vigilance to prevent adverse events. All patients must be assessed for level of risk. Adaptations to the plan of care and monitoring strategies should be driven by iterative re-assessments according to level of risk. NURSING PRACTICE IMPLICATIONS: Opioid medications continue to be a major component in the management of acute pain. Clinicians have the primary responsibility for safe and effective pain management. Evidence based monitoring strategies can improve patient safety with opioids.

Pregnancy Outcomes After Exposure to Certolizumab Pegol: Updated Results From a Pharmacovigilance Safety Database.

OBJECTIVE: Anti-tumor necrosis factor (anti-TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy. METHODS: Prospective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained. RESULTS: Of 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies. CONCLUSION: This analysis represents the largest cohort of pregnant women exposed to an anti-TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.

Safety of cetirizine in pregnancy.

Managing symptoms of allergic rhinitis (AR) and urticaria in pregnant women is important to reduce complications and negative outcomes. The objective of this study was to provide information on the pregnancy outcomes of women exposed to the antihistamine cetirizine (CTZ). The UCB Pharma Patient Safety Database was searched for pregnancies up to 28 February 2015. Maternal CTZ exposure reports were extracted, and pregnancy outcomes were examined, including exposure, comorbidities and infant events. 228 of 522 pregnancies with maternal CTZ exposure had available outcomes; 49 were prospective. The majority (83.7%) resulted in live births; four spontaneous miscarriages, three induced abortions and one stillbirth were reported. Most pregnancies were exposed during the first trimester. Two congenital malformations were reported. The results suggest that CTZ exposure is not associated with adverse pregnancy outcomes above the background rates. While reassuring, the strengths and limitations of a safety database study need to be considered. Impact statement What is already known on this subject? AR and urticaria can substantially affect pregnant women, and adequately managing their symptoms is important to reduce maternal and foetal complications. Antihistamines are efficacious, however, there is still a lack of data regarding use during pregnancy. Although current evidence indicates that antihistamines are well-tolerated during pregnancy, data regarding foetal safety are inconclusive. What do the results of this study add? Our study suggests that CTZ exposure during pregnancy is not linked to an increase in adverse outcomes. CTZ exposure mainly happened during the first trimester only, when most organogenesis takes place. Most of the maternally exposed, prospective pregnancies resulted in live births (83.7%). Congenital malformations occurred in 2/41 live births from the CTZ-exposed pregnancies. What are the implications of these findings for clinical practice and/or further research? Our study presents a detailed data analysis from a large number of CTZ-exposed pregnancies, and its results are in line with those from previous reports. While the limitations of a safety database study need to be considered, the results shown here are reassuring. Further prospectively reported pregnancies are required, before definite conclusions on the risks of CTZ exposure during pregnancy can be drawn.

Incidence and prevalence of axial spondyloarthritis: methodologic challenges and gaps in the literature.

OBJECTIVES: The incidence and prevalence of axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-)axSpA, have been investigated in multiple populations, though there is a paucity of population-level data. Here, we identify population-based studies in AS and nr-axSpA, and describe the methodologic challenges in conducting these, outlining potential reasons for disparate incidence and prevalence estimates. METHODS: PubMed and Embase were searched for population-based studies providing incidence and prevalence rates, published in English from 1 Jan 2000-30 Jun 2015. Extracted information included incidence/prevalence rates, geographical population, study design, data source, case definition, age/gender, and classification criteria used. RESULTS: Of 2,148 articles identified, 19, from 15 countries, fulfilled eligibility criteria. Incidence rates per 100,000 patient-years were reported in 4 AS studies and varied from 0.4 (Iceland) to 15.0 (Canada). Reported AS prevalence rates per 100,000 persons also showed considerable variation (16 studies: 6.5 [Japan] to 540.0 [Turkey]). Only 3 axSpA and no nr-axSpA prevalence rates were reported. Considerable variation was seen in the methodology used to estimate incidence and prevalence rates, e.g. screening method, study design, and classification criteria. Although the prevalence of AS is known to vary by HLA-B27 status, only 4 studies reported this genetic marker. CONCLUSIONS: There is an unmet need for future studies to use consistent methodology, capture all relevant information (including HLA-B27 positivity), and investigate under-reported populations (e.g. nr-axSpA; southern hemisphere countries) to estimate the population burden of axSpA. Future studies should aim to address data gaps to provide accurate incidence/prevalence estimates for the global axSpA population.

Treatment of ulcerative compared to non-ulcerative interstitial cystitis with hyperbaric oxygen: a pilot study.

BACKGROUND: The etiology of interstitial cystitis (IC) is often idiopathic but can be due to Hunner's ulcers. Hyperbaric oxygen (HBO) is used to treat ulcerative disease of the superficial skin. We hypothesized that HBO can treat ulcerative IC (UIC) but would be less efficacious for non-ulcerative IC (NIC). METHODS: Patients with NIC and UIC enrolled in this study. Following informed consent, demographic information was collected. A visual analog pain scale and validated questionnaires were collected; each patient underwent cystoscopy prior to treatment. Each subject met with a hyperbaric specialist and after clearance underwent 30 treatments over 6 weeks. Adverse events were monitored. Patients repeated questionnaires, visual analog pain scale and global response assessment (GRA) immediately, 2 weeks, 3, 6 and 12 months after treatment. Patients also underwent cystoscopy 6 months after treatment. Differences before and after treatment were compared. RESULTS: Nine patients were recruited to this study. One was unable to participate, leaving two subjects with NIC and six with UIC. All patients completed HBO without adverse events. Three patients completed HBO but pursued other therapies 7, 8.5 and 11 months after treatment. On GRA, 83% of patients with UIC were improved. This treatment effect persisted, as 66% of UIC patients remained better at 6 months. In contrast, only one patient in the NIC group improved. Questionnaire scores improved in both groups. Pain scores improved by 2 points in the UIC group but worsened by 1.5 points in the NIC group. Two patients with ulcers resolved at 6-month cystoscopy. CONCLUSION: HBO appeared beneficial for both UIC and NIC. Data shows slightly better benefit in patients with UIC compared to NIC; both groups showed improvement. Given the small sample size, it is difficult to draw definitive conclusions from these data. Larger studies with randomization would be beneficial to show treatment effect.

Proof of concept trial on changes in current perception threshold after sacral neuromodulation.

OBJECTIVES: Sacral neuromodulation (SNM) is theorized to alter the neural pathways that mediate bladder and urethral sensation. We hypothesize that SNM affects current perception thresholds (CPTs) of afferent sensory nerve pathways. MATERIALS AND METHODS: Eight women were enrolled and completed pre and postoperative testing. A CPT device was used to measure CPT at 5 Hz (C-fibers), 250 Hz (Aδ-fibers), and 2000 Hz (Aß-fibers) on the urethra and bladder prior to and one month after SNM. Index finger readings at 2000 Hz served as controls. RESULTS: SNM had the greatest effect on the bladder at 250 and 2000 Hz, suggesting reduced bladder sensitivity. Significant changes in CPT were seen in the bladder at 2000 Hz with a decrease in sensitivity (p = 0.033). CPT testing was well tolerated, and no adverse events were identified. CONCLUSIONS: With a measurable change in CPT values for Aδ-fibers and Aß-fibers, these findings suggest that SNM modulates large myelinated afferent fibers in the bladder. Notably, little or no changes were found in the C-fiber CPT measurements. More research is needed with a larger sample size to determine the significance of these findings.

American Society for Pain Management Nursing position statement with clinical practice guidelines: authorized agent controlled analgesia.

The American Society for Pain Management Nursing (ASPMN) has updated its 2007 position statement on the use of authorized agent controlled analgesia (AACA) for patients who are unable to independently utilize patient-controlled analgesia (PCA). ASPMN continues to support the use of AACA to provide timely and effective pain management while promoting equitable care for vulnerable patient populations who are unable to utilize PCA. ASPMN does not support the use of "PCA by Proxy" in which unauthorized individuals activate PCA for a patient. The background of the development of the position statement, definitions related to AACA, and application of ethical principles to the use of AACA are presented in the document. This position statement includes an updated review of the evidence related to AACA and a call for further research. Clinical practice recommendations for authorized agents, nurses, prescribers, and organizations are provided with an emphasis on the importance of appropriate authorized agent selection, education, diligent patient assessment and medication management.

Persistent organochlorine pollutants and menstrual cycle characteristics.

An evolving body of evidence suggests an adverse relation between persistent organochlorine pollutants (POPs) and menstruation, though prospective longitudinal measurement of menses is limited and served as the impetus for study. We prospectively assessed the relation between a mixture of persistent organochlorine compounds and menstrual cycle length and duration of bleeding in a cohort of women attempting to become pregnant. Eighty-three (83%) women contributing 447 cycles for analysis provided a blood specimen for the quantification of 76 polychlorinated biphenyls and seven organochlorine pesticides, and completed daily diaries on menstruation until a human chorionic gonadotropin confirmed pregnancy or 12 menstrual cycles without conception. Gas chromatography with electron capture detection was used to quantify concentrations (ng g(-1)serum); enzymatic methods were used to quantify serum lipids (mg dL(-1)). A linear regression model with a mixture distribution was used to identify chemicals grouped by purported biologic activity that significantly affected menstrual cycle length and duration of bleeding adjusting for age at menarche and enrollment, body mass index, and cigarette smoking. A significant 3-d increase in cycle length was observed for women in the highest tertile of estrogenic PCB congeners relative to the lowest tertile (ß=3.20; 95% CI 0.36, 6.04). A significant reduction in bleeding (<1 d) was observed among women in the highest versus lowest tertile of aromatic fungicide exposure (γ=-0.15; 95% CI -0.29, -0.00). Select POPs were associated with changes in menstruation underscoring the importance of assessing chemical mixtures for female fecundity.

Clustering of fecundability within women.

Adverse pregnancy outcomes have long been observed to cluster within women resulting in the inclusion of past reproductive history in clinical assessments and perinatal scoring systems. However, limited study has focused on the clustering of fecundability as measured by time to pregnancy (TTP), despite growing evidence suggestive of a possible association with adverse pregnancy outcomes known to cluster within women. We sought to empirically evaluate the clustering of conception delay, and TTP more globally, in one of the few existing prospective pregnancy cohort studies that captured women's successive pregnancies. The study cohort comprised 544 women who contributed 1119 pregnancies in the U.S. Collaborative Perinatal Project. We used a discrete Cox frailty model to estimate the degree and significance of within-woman clustering of TTP. Women with an initial conception delay (TTP > 6 months) were older, less educated and had higher body mass indices than women not experiencing delays (TTP ≤ 6 months). Our analysis indicates that there is significant within-woman clustering of TTP (variance of the frailty = 0.80, [95% confidence interval 0.49, 1.11]) after adjusting for baseline maternal age, body mass index and education level. Similar to many other reproductive and perinatal outcomes, our findings suggest that TTP clusters within women. Identifying exposures or behaviours that affect TTP may offer strategies for reducing conception delay in future pregnancy attempts.

Validity of retrospectively reported behaviors during the periconception window.

OBJECTIVE: To assess the validity of retrospectively reported maternal behaviors while attempting pregnancy. STUDY DESIGN: Participants in a prospective pregnancy cohort study with periconception enrollment were queried about use of cigarettes, alcohol, vitamins and caffeine and the consumption of sport fish while attempting pregnancy. Prospective longitudinal data reported in daily diaries (gold standard) were compared with data obtained a decade later using a self-administered questionnaire. Agreement was assessed by percent agreement and Kappa coefficients. RESULTS: Among the 82 participating women, percent agreement ranged from 54-74% for the 5 behaviors. Validity was highest for smoking (Kappa = 0.43, 95% confidence interval [CI]: 0.22, 0.65) followed by fish consumption (Kappa = 0.32, 95% CI: 0.09, 0.55), caffeine (Kappa = 0.21, 95% CI: 0.09, 0.51) and alcohol (Kappa = 0.20, 95% CI: 0.08, 0.33). There were no systematic differences in agreement by time to pregnancy or pregnancy outcome. Associations between smoking and alcohol consumption and pregnancy outcomes were highly sensitive to the levels of misclassification observed in this study. CONCLUSION: Validity was poor to moderate for the 5 behaviors, though higher for more regular behaviors such as smoking and caffeine consumption. The potential for misreporting of periconception behaviors can affect inferences, and thus efforts to capture information prospectively should be promoted.

HIT heparin-induced thrombocytopenia.

Heparin-induced thrombocytopenia (HIT) is a significant complication of heparin therapy. The NP is in a pivotal position to identify patients at greater risk for HIT and promptly diagnose and intervene to prevent serious thrombotic complications.