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Andrea Fabbri,1 Alberto M Borobia,2 Agnes Ricard-Hibon,3 Frank Coffey,4 Aurore Caumont-Prim,5 François Montestruc,5 Amedeo Soldi,6 Susana Traseira Lugilde,7 Sara Dickerson8 1Department of Emergency Medicine, Morgagni-Pierantoni Hospital, Forli, Italy; 2Clinical Pharmacology Department, La Paz University Hospital, School of Medicine, Universidad Autónoma de Madrid, IdiPAZ, Madrid, Spain; 3Emergency Department SAMU-SMUR 95, CHG Pontoise-Beaumont/Oise, Pontoise, France; 4DREEAM: Department of Research and Education in Emergency Medicine, Acute Medicine and Major Trauma, Nottingham University Hospitals NHS Trust, Nottingham, UK; 5eXYSTAT, Malakoff, France; 6Mundipharma Pharmaceuticals Srl, Milan, Italy; 7Mundipharma Pharmaceuticals S.L., Madrid, Spain; 8Mundibiopharma Limited, Cambridge, UKCorrespondence: Sara DickersonMundibiopharma Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0AB, UKTel +44 1223 397684Email Sara.Dickerson@mundipharma.comPurpose: Undertreatment of trauma-related pain is common in the pre-hospital and hospital settings owing to barriers to the use of traditional standard of care analgesics. Low-dose methoxyflurane is an inhaled non-opioid analgesic with a rapid onset of pain relief that is approved for emergency relief of moderate-to-severe trauma-related pain in adults. This analysis was performed to compare the efficacy and safety of low-dose methoxyflurane with standard of care analgesics in adults with trauma-related pain.Methods: A meta-analysis was performed on pooled data from randomized controlled trials identified via a systematic review. The primary endpoint was the pain intensity difference between baseline and various time intervals (5, 10, 15, 20, and 30 minutes) after initiation of treatment.Results: The pain intensity difference was statistically superior with low-dose methoxyflurane compared with standard of care analgesics (overall estimated treatment effect=11.88, 95% CI=9.75– 14.00; P< 0.0001). The superiority of low-dose methoxyflurane was demonstrated at 5 minutes after treatment initiation and was maintained across all timepoints. Significantly more patients treated with methoxyflurane achieved response criteria of pain intensity ≤ 30 mm on a visual analog scale, and relative reductions in pain intensity of ≥ 30% and ≥ 50%, compared with patients who received standard of care analgesics. The median time to pain relief was shorter with methoxyflurane than with standard of care analgesics. The findings were consistent in a subgroup of elderly patients (aged ≥ 65 years).Conclusion: Methoxyflurane can be considered as an alternative to standard of care analgesics in pre-hospital and hospital settings for treatment of adult patients with acute trauma-related pain.Keywords: acute pain, inhaled analgesic, emergency service, wounds and injury, pain management, analgesia

ObjectiveTo determine treatment persistence and exacerbations in patients initiating inhaler treatment with fixed-dose combinations of inhaled corticosteroids/long-acting beta-2-adrenergic agonists (ICS/LABA) for the treatment of asthma.DesignRetrospective observational study conducted by review of electronic medical records (database: Fundación RediSS).SettingRetrospective cohort study. The follow-up period was 1 year.ParticipantsThe study included patients aged ≥18 years who started treatment with ICS/LABA and met the inclusion/exclusion criteria.Main outcomes and measuresThe study groups were fluticasone propionate/salmeterol (FP/SAL), beclomethasone/formoterol (BDP/FORM), budesonide/formoterol (BUD/FORM), fluticasone furoate/vilanterol (FF/VI) and fluticasone propionate/formoterol (FP/FORM). The main measurements were persistence, medication possession ratio (MPR) and exacerbations. Statistical significance was established as pResultsIn total, 3203 patients were recruited for the study. By groups, 31.1% FP/SAL, 28.6% BDP/FORM, 25.0% BUD/FORM, 8.2% FF/VI and 7.0% FP/FORM. The mean age was 52.2 years, 60.8% were female and 44.9% had persistent-moderate asthma. Treatment persistence was 61.7% (95% CI 60.0% to 63.4%) and by study group it was FP/SAL: 60.7%, BDP/FORM: 61.2%, BUD/FORM: 60.3%, FF/VI: 66.7% and FP/FORM: 67.6% (p=0.046). MPR by study group was FP/SAL: 74.3%, BDP/FORM: 73.8%, BUD/FORM: 74.6%, FF/VI: 79.4% and FP/FORM: 80.6% (p=0.028). The mortality rate was 2.9%. By treatment group, exacerbations were FP/SAL: 21.9% (95% CI 19.3% to 24.5%), BDP/FORM: 22.2% (95% CI 19.5% to 24.9%), BUD/FORM: 22.8% (95% CI 19.9% to 25.7%), FF/VI: 17.9% (95% CI 14.9% to 20.7%) and FP/FORM: 16.0% (95% CI 12.2% to 19.3%), p=0.036.ConclusionsPatients undergoing treatment with FP/FORM and FF/VI versus FP/SAL, BDP/FORM and BUD/FORM were associated with greater treatment adherence (persistence, MPR) and lower rates of exacerbations. However, further studies will be needed to strengthen the consistency of the results.

Study objective The objective of the InMEDIATE study was to evaluate the change in intensity of traumatic pain over the first 20 min in adult patients treated with methoxyflurane versus standard analgesic treatment in Spain. This the first randomized, active-controlled, multicenter trial of methoxyflurane in the emergency setting in Europe. Methods This was a randomized, controlled study that enrolled adult patients with acute moderate to severe (score ≥4 on the 11-point Numeric Rating Scale) trauma-associated pain in 14 Spanish emergency departments. Patients were randomized 1:1 to methoxyflurane (up to 2×3 mL) or standard analgesic treatment. Coprimary endpoints were the change from baseline in Numeric Rating Scale pain intensity score during the first 20 minutes of treatment and time to first pain relief. Results Three hundred five patients were randomized (methoxyflurane 156; standard analgesic treatment 149). Most patients in the standard analgesic treatment group (70%) received intravenous first-step analgesics and 9.4% of patients were treated with opioids. Mean decrease from baseline in Numeric Rating Scale pain intensity score was greater for methoxyflurane than standard analgesic treatment at all points, with a significant treatment difference overall up to 20 minutes (repeated-measures model 2.47 versus 1.39; treatment difference 1.00; 95% confidence interval 0.84 to 1.32). Median time to first pain relief was significantly shorter for methoxyflurane than standard analgesic treatment (3 versus 10 minutes). Methoxyflurane achieved better patient and clinician ratings for pain control and comfort of treatment than standard analgesic treatment and exceeded patient and clinician expectations of treatment in, respectively, 77% and 72% of cases compared with 38% and 19% for standard analgesic treatment. Conclusion These results support consideration of methoxyflurane as a nonnarcotic, easy-to-administer, rapid-acting, first-line alternative to currently available analgesic treatments for trauma pain.

Bone metastasis is the most common cause of cancer-related pain, and metastatic bone pain (MBP) is not only severe but also progressive in many patients. The aim of this study was to investigate the association between pain management and performance status in patients with metastatic bone cancer in the Spanish clinical setting. A 3-month follow-up prospective, epidemiologic, multicenter study was conducted in 579 patients to assess the evolution of their performance, the impact of pain control on sleep and functionality, and the degree of pain control according to analgesic treatment. In patients with MBP, Eastern Cooperative Oncology Group (ECOG) status (1.5 ± 0.7–1.3 ± 0.7 and 1.3 ± 0.8; p

Identification of causes involved in low back pain (LBP) should contribute to improving the clinical management. A large multicenter observational study assessing the prevalence of LBP causes in Spain. Patient-reported pain, dysfunctionality, and health-related quality of life (HQoL) outcomes after 3 months were registered by the Brief Pain Inventory Short Form (BPI-SF), Oswestry Disability Index (ODI), European Quality of Life-5 Dimensions (EQ-5D), and the Patient’s Global Impression of Change (PGIC). Data analysis was also stratified by the different disciplines of care. Overall, 6436 patients were recruited mainly in traumatology, rehabilitation, rheumatology, and pain units. Mechanical pain was identified in 92.8 % of patients. Although only 30.7 % of specialists reported use of any chronic LBP characterization system on their daily practice, all patients in the study had any diagnostic test. After 3 months, significant benefits were observed in pain outcomes and functional disability, given the decrease in BPI-SF scores (6.3 vs. 3.4; P

The Brief Pain Inventory (BPI) is a widely used pain measurement tool. There are 2 versions, the BPI Long Form (BPI-LF) and Short Form (BPI-SF), which share 2 core scales measuring pain severity and pain interference but which use different recall periods (24 hours vs. 1 week). To date, the BPI-SF has not been validated for use in Spain. This study investigated the psychometric properties of the BPI-SF Spanish version and compared results on the core scales between BPI-LF and BPI-SF. The data came from a 3-month observational study of 3,029 nononcologic patients managed in Spanish pain units. The BPI-SF's reliability, validity, and responsiveness were assessed. The effect of different recall periods was investigated by using intraclass correlation coefficients (ICCs) to determine the strength of correlation between BPI-LF and BPI-SF. The BPI-SF showed good reliability, with Cronbach's alphas of 0.931 for the severity and interference scales, which also discriminated well between patients reporting different levels of quality of life on EuroQol-5D dimensions (between group effect sizes [ESs] over 0.8). Substantial improvements were seen on both subscales after 3 months of treatment (ES of 1.76 for pain severity and 1.51 for pain interference). Recall period did not noticeably affect scores; ICCs (95% CI) between the long and short versions were 0.946 (0.938 to 0.954) and 0.929 (0.919 to 0.939) for the severity and interference subscales, respectively. The Spanish version of the BPI-SF is a valid and reliable instrument to measure pain severity and interference.