Factors influencing clinical trial participation of women with fibromyalgia across the United States: a cross-sectional survey.

Although fibromyalgia is a widespread chronic pain condition where 90 percent of patients are women, they are underrepresented in Randomized Clinical Trials (RCTs). We aim to describe the willingness to participate, assess different factors, and explore the impact of sociodemographic and clinical characteristics on perceived barriers to trial participation. This is a cross-sectional survey targeting women with fibromyalgia. Univariate and multivariate logistic regression were performed. Of the 436 women with fibromyalgia, 56 percent were very likely to participate in RCTs. Minorities expressed less interest than non-minorities, while higher pain scores, previous participation, and younger patients reported a higher interest. Barriers significantly associated with a reduced willingness were: the participant's perception (side effects, distance, potential negative impact), the center (reputation), the trial protocol (number of visits, placebo), and trial awareness by their physician. In a multivariate analysis, older age, low education, lower income, and higher pain scores were associated with perceived barriers to RCT participation. Despite the high interest to participate, factors such as side effects, the center's distance, number of visits, placebo treatments, and the institution's reputation must be considered in clinical trials for women with fibromyalgia.

Development, psychometric evaluation and validation of a brief measure of emotional preoperative stress (B-MEPS) to predict moderate to intense postoperative acute pain.

BACKGROUND: Preoperative stress might influence postoperative pain, thereby, it is desirable to assess it more precisely. Thus, we developed and evaluated the psychometric properties of a brief measure of emotional preoperative stress (B-MEPS) index using Item Response Category Characteristic Curves. We validated and assessed whether the B-MEPS can predict moderate to intense acute postoperative pain (MIAPP). METHODS: We included 863 adult patients who underwent elective surgeries (ASA I-III physical status). The B-MEPS was constructed based on items selected from instruments to assess anxiety, depression, future self-perception and minor psychiatric disorders. We identified 24 items with greatest discriminant power to identify patients who should undergo surgery to treat cancer with MIAPP. The reliability was maximized using the Cronbach's alpha indices. Fifteen items remained, which were adjusted by the Generalized Partial Credit Model. The convergent validity was assessed correlating the B-MEPS index with the pain catastrophizing (n = 100). Finally, the B-MEPS was applied in a prospective cohort of patients who underwent an abdominal hysterectomy (n = 150). RESULTS: The Cronbach's alpha for selected items was 0.83. The correlation coefficient between B-MEPS index and catastrophizing was r = 0.37 (P < 0.01). A hierarchical regression model evidenced that the B-MEPS index was a factor independent to predict MIAPP after an abdominal hysterectomy [odds ratio (OR)=1.20, confidence interval (CI) 95% 1.05-1.43). CONCLUSIONS: The B-MEPS index presents satisfactory psychometric evaluations based on its internal consistency, convergent, and discriminant validity. The B-MEPS is a propensity index to MIAPP, which might help the clinician to decide on the best therapeutic approaches for acute postoperative pain.

Neonatal morphine administration leads to changes in hippocampal BDNF levels and antioxidant enzyme activity in the adult life of rats.

It is know that repeated exposure to opiates impairs spatial learning and memory and that the hippocampus has important neuromodulatory effects after drug exposure and withdrawal symptoms. Thus, the aim of this investigation was to assess hippocampal levels of BDNF, oxidative stress markers associated with cell viability, and TNF-α in the short, medium and long term after repeated morphine treatment in early life. Newborn male Wistar rats received subcutaneous injections of morphine (morphine group) or saline (control group), 5 µg in the mid-scapular area, starting on postnatal day 8 (P8), once daily for 7 days, and neurochemical parameters were assessed in the hippocampus on postnatal days 16 (P16), 30 (P30), and 60 (P60). For the first time, we observed that morphine treatment in early life modulates BDNF levels in the medium and long term and also modulates superoxide dismutase activity in the long term. In addition, it was observed effect of treatment and age in TNF-α levels, and no effects in lactate dehydrogenase levels, or cell viability. These findings show that repeated morphine treatment in the neonatal period can lead to long-lasting neurochemical changes in the hippocampus of male rats, and indicate the importance of cellular and intracellular adaptations in the hippocampus after early-life opioid exposure to tolerance, withdrawal and addiction.

Preoperative predictors of moderate to intense acute postoperative pain in patients undergoing abdominal surgery.

BACKGROUND: Pain is a sensory and emotional experience that is influenced by physiologic, sensory, affective, cognitive, socio-cultural, and behavioral factors. Consistent with the perspective to improve the postoperative pain control, the present study has the purpose of assessing the effect of presurgical clinical factors, psychological and demographic characteristics as predictors for reporting moderate to intense acute postoperative pain. METHODS: A prospective cohort study was performed with 346 inpatients undergoing abdominal elective surgery (ASA physical status I-III, age range 18-60 years). The measuring instruments were Pain Visual Analog Scale, the State-Trait Anxiety Inventory, and the Montgomery-Asberg Depression Rating Scale. Multivariate conditional regression modeling was used to determine independent predictors for moderate to intense acute postoperative pain. RESULTS: Moderate to intense acute postoperative pain was associated with status ASA III (odds ratio (OR) = 1.99), age (OR = 4.72), preoperative moderate to intense pain (OR = 2.96), chronic pain (OR = 1.75), high trait-anxiety and depressive mood moderate to intense (OR = 1.74 and OR = 2.00, respectively). Patients undergoing surgery to treat cancer presented lower risk for reporting moderate to intense pain OR = 0.39, as well as those that received the epidural analgesia and multimodal analgesia with systemic opioid (OR = 0.09 and OR = 0.16, respectively). CONCLUSIONS: The identification of predictive factors for intense acute postoperative pain may be useful for designing specific preventive interventions to relieve patient suffering. Especially because few of these variables are accessible for medical intervention, which would improve the clinical outcomes and quality of life of patients at risk of moderate to intense acute postoperative pain.

Effect of pre-operative anxiolysis on postoperative pain response in patients undergoing total abdominal hysterectomy.

In a double blind, placebo-controlled trial, we have assessed the effects of pre-operative anxiolysis on postoperative pain scores in 112 ASA I-II women, aged 18-65 years, scheduled to undergo total abdominal hysterectomy. Subjects were randomly allocated to receive either oral diazepam 10 mg (n=56) or placebo (n=56) pre-operatively. Postoperative anxiety, pain scores, analgesic consumption, and sedation were evaluated at several time points during the first 24 h following surgery. Postoperative pain scores were found to be significantly higher in the diazepam group. Trait and state anxiety showed a significant effect on pain scores, independent of the treatment group. No difference was found between the groups in morphine consumption, but there was a significant reduction in morphine consumption with time.

Risk factors for postoperative anxiety in adults.

We identified risk factors for postoperative anxiety and quantified their effect on 712 adults between 18 and 60 years of age (ASA I-III physical status) undergoing elective surgery under general anaesthesia, neural blockade or both. The measuring instruments were a structured questionnaire, a pain visual analogue scale, the McGill Pain Questionnaire, the State-Trait Anxiety Inventory, the Montgomery-Asberg Depression Rating Scale, a Self-Reporting Questionnaire-20, and a Self-Perception of Future Questionnaire. Multivariate conditional regression modelling taking into account the hierarchical relationship between risk factors revealed that postoperative anxiety was associated with ASA status III (OR = 1.48), history of smoking (1.62), moderate to intense postoperative pain (OR = 2.62) and high pain rating index (OR = 2.35), minor psychiatric disorders (OR = 1.87), pre-operative state-anxiety (OR = 2.65), and negative future perception (OR = 2.20). Neural block anaesthesia (OR = 0.72), systemic multimodal analgesia (OR = 0.62) and neuroaxial opioids with or without local anaesthesia (OR = 0.63) were found to be protective factors against postoperative anxiety.

Risk factors for preoperative anxiety in adults.

BACKGROUND: Patients who undergo surgery experience acute psychological distress in the preoperative period. The objective of this study was to identify and quantify the effect of risk factors for preoperative anxiety in adults. METHODS: A cross-sectional study was performed with 592 inpatients scheduled for elective surgery. Age ranged from 18 to 60 years (ASA physical status I-III). Demographic information was collected using a structured questionnaire. The measuring instruments were a visual analog scale, the State-Trait Anxiety Inventory; the Montgomery-Asberg Depression Rating Scale, the WHO Self-Reporting Questionnaire-20, and the future self-perception questionnaire. Multivariate conditional regression modeling was used to control confounding factors and to determine independent predictors of preoperative anxiety, taking into account the hierarchical relationship between risk factors. RESULTS: High preoperative anxiety was associated with history of cancer (odds ratio (OR)=2.26) and smoking (OR=7.47), psychiatric disorders (OR=5.93), negative future perception (OR= 2.30), moderate to intense depressive symptoms (3.22), high trait-anxiety (3.83), moderate to intense pain (2.12), medium surgery (OR=1.52), female gender (OR=2.0), ASA category III (OR=3.41), up to 12 years of education (OR=1.36), and more than 12 years of education (OR=1.68). Previous surgery (OR= 0.61) was associated with lower risk for preoperative state-anxiety. CONCLUSIONS: History of cancer and smoking, psychiatric disorders, negative future perception, moderate to intense depressive symptoms, high trait-anxiety, moderate to intense pain, medium surgery, female gender, ASA category III, up to 12 years of education and more than 12 years of education constituted independent risk factors for preoperative state-anxiety. Previous surgery reduced the risk for preoperative anxiety.

Risk factors for postoperative anxiety in children.

BACKGROUND: Anxiety is defined as a set of behavioural manifestations that can be divided into state- and trait-anxiety. State-anxiety is a transitory emotional condition that varies in intensity and fluctuates over time. Trait-anxiety is a personality trait which remains relatively stable over time. The objective of this study was to identify and quantify perioperative risk factors for immediate postoperative anxiety in children. METHODS: A prospective cohort study was performed with 90 schoolchildren, ages ranging from 7 to 13 years old, ASA physical status I-II, submitted to elective surgery. The measuring instruments were verbal scale of pain, visual analogue scale (VAS), Trait-State Anxiety Inventory for Children (STAIC), Trait-State Anxiety Inventory (STAI) for parents, and structured questionnaire. RESULTS: Patients not submitted to analgesic block and patients with moderate and intense pain presented an estimated risk 5- and 13-fold greater for high levels of postoperative state-anxiety, respectively. High levels of preoperative state-anxiety and administration of doses of midazolam less than 0.056 mg x kg(-1) constituted an estimated risk for postoperative state-anxiety of 3- and 4-fold, respectively. A positive history of previous surgery was associated with lower risk for postoperative anxiety. CONCLUSIONS: High levels of preoperative state-anxiety, administration of less than 0.056 mg x kg(-1) of midazolam, absence of analgesic block and presence of moderate and intense postoperative pain constituted risk factors for immediate postoperative state-anxiety in children. Previous surgery reduced the risk for postoperative anxiety.