The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
Determination of the effective dose of pregabalin on human experimental pain using the sequential up-down method.
The intradermal capsaicin pain model has been used to evaluate analgesic effects of a variety of drugs. Using the sequential up-down method, we examined the analgesic effects of pregabalin on intradermal capsaicin pain. Using a double-blind, placebo-controlled, crossover study, healthy adult men were randomized to oral pregabalin or placebo on the first visit and returned for the opposite treatment after a washout period. Dosing was set by the Dixon sequential up-down method; that is, a greater or less than 30% reduction in capsaicin pain decreased or increased the dose, respectively, by a fixed interval for the next subject. The median effective dose (ED50) was derived once 7 changes in dose direction occurred. Secondary outcome measures included secondary hyperalgesia and tactile and thermal allodynia, and their respective areas (cm(2)). Thirteen subjects were required to derive the pregabalin ED50: 252 mg (95% confidence interval 194, 310 mg). Most common side effects were drowsiness (46%), euphoria (31%), and dizziness (7%). Those with ≥30% pain reduction as compared to placebo also had similar reductions in secondary outcome measures. The intradermal capsaicin pain model can be used to efficiently derive the pregabalin ED50, but well-powered dose-response curve studies are needed for comparison and validation. ⋯ Using the Dixon sequential up-down method, the ED50 of pregabalin on intradermal capsaicin induced pain was successfully calculated (252 mg) using only 13 subjects.
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Multicenter Study Comparative Study
Comparisons of patient and physician assessment of pain-related domains in cancer pain classification: results from a large international multicenter study.
The aim of the present study is to compare physician clinical assessment with patient-rated evaluations in the classification of cancer pain patients into groups with different pain levels, according to the presence of incident/breakthrough pain, neuropathic pain, and psychological distress. Average pain in the previous 24 hours was used as the dependent variable in multivariate linear regression models, and incident/breakthrough pain, neuropathic pain, and psychological distress were tested as regressors; in the assessment of regressors, physicians used the Edmonton Classification System for Cancer Pain, whereas patients used structured self-assessment questionnaires. The amount of variability in pain intensity scores explained by the 2 sets of regressors, physician and patient rated, was compared using R(2) values. When tested in 2 separate models, patient ratings explained 20.3% of variability (95% confidence interval [CI] = 15.2-25.3%), whereas physician ratings explained 6.1% (95% CI = 2.2-9.8%). The higher discriminative capability of patient ratings was still maintained when both regressor sets were introduced in the same model, with R(2) indices of 17.6% (95% CI = 13.0-22.2%) for patient ratings vs 3.4% (95% CI = .9-5.9%) for physician ratings. Patients' self-assessment of subjective symptoms should be integrated in future cancer pain classification systems. ⋯ Our results indicate that patient-structured assessment of incident/breakthrough pain, neuropathic pain, and psychological distress significantly contributes to the discrimination of cancer patients with different pain levels. The integration of patient self-assessment tools with more objective clinician assessments can improve the classification of cancer pain.
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Factors contributing to pain following surgery are poorly understood, with previous research largely focused on adults. With approximately 6 million children undergoing surgery each year, there is a need to study pediatric persistent postsurgical pain. The present study includes patients with adolescent idiopathic scoliosis undergoing spinal fusion surgery enrolled in a prospective, multicentered registry examining postsurgical outcomes. The Scoliosis Research Society Questionnaire-Version 30, which includes pain, activity, mental health, and self-image subscales, was administered to 190 patients prior to surgery and at 1 and 2 years postsurgery. A subset (n = 77) completed 5-year postsurgery data. Pain prevalence at each time point and longitudinal trajectories of pain outcomes derived from SAS PROC TRAJ were examined using analyses of variance and post hoc pairwise analyses across groups. Thirty-five percent of patients reported pain in the moderate to severe range presurgery. One year postoperation, 11% reported pain in this range, whereas 15% reported pain at 2 years postsurgery. At 5 years postsurgery, 15% of patients reported pain in the moderate to severe range. Among the 5 empirically derived pain trajectories, there were significant differences on self-image, mental health, and age. Identifying predictors of poor long-term outcomes in children with postsurgical pain may prevent the development of chronic pain into adulthood. ⋯ This investigation explores the prevalence of pediatric pain following surgery, up to 5 years after spinal fusion surgery. Five pain trajectories were identified and were distinguishable on presurgical characteristics of age, mental health, and self-image. This is the largest study to examine longitudinal pediatric pain trajectories after surgery.
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Multicenter Study
Engendering pain management practices: the role of physician sex on chronic low-back pain assessment and treatment prescriptions.
The impact of physician sex on dimensions of medical care such as treatment prescriptions and referrals has been underexplored, especially in a pain context. Also, few studies have analyzed whether physician sex moderates the influence of patients' or clinical situations' characteristics on pain management practices or its mediating processes. Therefore, our goal was to explore whether physician sex moderates the effects of patient (distressed) pain behaviors and diagnostic evidence of pathology (EP) on treatment prescriptions and referrals for chronic low-back pain, and to explore the mediating role of pain credibility judgments and psychological attributions on these effects. A total of 310 general practitioners (GPs; 72.6% women) participated in a between-subjects design, 2 (patient pain behaviors) × 2 (EP) × 2 (GP sex) × 2 (patient sex). GPs were presented with vignettes depicting a fe(male) chronic low-back pain patient, with(out) distress and with(out) EP (eg, herniated disc). GPs judged the patient's pain and the probability of treatment prescriptions and referrals. Results showed that EP had a larger effect on male than on female physicians' referrals to psychology/psychiatry. Also, GP sex moderated the pain judgments that accounted for the effect of EP and pain behaviors on prescriptions. These findings suggest framing medical decision-making as a process influenced by gender assumptions. ⋯ This paper shows that physician sex moderates the influence of clinical cues on pain management practices and the mediating role of pain judgments on these effects. It may potentially increase clinicians' awareness of the influence of gender assumptions on pain management practices and contribute to the development of more gender-sensitive services.
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Multicenter Study
Pain treatment for older adults during prehospital emergency care: variations by patient gender and pain severity.
Older adults are less likely than younger adults to receive analgesic treatment during emergency department visits. Whether older adults are less likely to receive analgesics during protocolized prehospital care is unknown. We analyzed all ambulance transports in 2011 in the state of North Carolina and compared the administration of any analgesic or an opioid among older adults (aged 65 and older) versus adults aged 18 to 64. Complete data were available for 407,763 transports. Older men were less likely than younger men to receive an analgesic or an opioid regardless of pain severity. Among women with mild or moderate pain, older women were less likely than younger women to receive either form of pain treatment, but among women with more severe pain (pain score 8 or more), older women were more likely than younger women to receive pain treatment. Further, among women with mild or moderate pain, the oldest patients (aged 85 and older) were the least likely to receive any analgesic or an opioid, but among women with severe pain the oldest patients were the most likely to receive treatment. Further research is needed to assess the generalizability of this interaction between age, gender, and pain severity on pain treatment. ⋯ During prehospital care in North Carolina in 2011, older adults were generally less likely to receive pain treatment. However, older women with severe pain were more likely to receive treatment than younger women with severe pain. These results suggest an interaction between age, gender, and pain severity on pain treatment.