Inhaled methoxyflurane for the management of trauma related pain in patients admitted to hospital emergency departments: a randomised, double-blind placebo-controlled trial (PenASAP study).

BACKGROUND: Oligo-analgesia is common in the emergency department (ED). This study aimed at reporting, when initiated by triage nurse, the superior efficacy of inhaled methoxyflurane plus standard of care (m-SoC) analgesia versus placebo plus SoC (p-SoC) for moderate-to-severe trauma-related pain in the hospital ED. METHODS: A randomised, double-blind, placebo-controlled trial was conducted at eight EDs. Adults with pain score ≥4 (11-point numerical rate scale, NRS) at admission were randomised to receive one or two inhalers containing m-SoC or p-SoC. Primary outcome measure was time until pain relief ≤30 mm, assessed on the 100-mm Visual Analogic Scale (VAS). RESULTS: A total of 351 patients were analysed (178 m-SoC; 173 p-SoC). Median pain prior to first inhalation was 66 mm, 75% had severe pain (NRS 6-10). Median time to pain relief was 35 min [95% confidence interval (CI), 28-62] for m-SoC versus not reached in p-SoC (92 - not reached) [hazard ratio), 1.93 (1.43-2.60), P < 0.001]. Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7). As SoC, 24 (7%) patients received weak opioids (6 versus 8%), 4 (1%) strong opioid and 44 (13%) escalated to weak or strong opioids (8 versus 17%, respectively, P = 0.02). Most adverse events were of mild (111/147) intensity. CONCLUSIONS: In this study, we report that methoxyflurane, initiated at triage nurse as part of a multimodal analgesic approach, is effective in achieving pain relief for trauma patients. This effect was particularly pronounced in the severe pain subgroup.

Non-interventional study evaluating exposure to inhaled, low-dose methoxyflurane experienced by hospital emergency department personnel in France.

OBJECTIVES: Low-dose methoxyflurane is a non-opioid, inhaled analgesic administered via the Penthrox inhaler and was recently licensed in Europe for emergency relief of moderate-to-severe trauma-associated pain in conscious adults. This non-interventional study investigated occupational exposure to methoxyflurane in the hospital emergency department (ED) personnel during routine clinical practice. SETTING AND PARTICIPANTS: The study was conducted in two hospital ED triage rooms in France over a 2-week and 3-week period, respectively. Low-dose methoxyflurane analgesia was self-administered by patients via the inhaler under the supervision of nursing staff, per routine clinical practice. An organic vapour personal badge sampler was attached to the uniform of the nurses working in the treatment rooms throughout an 8-hour shift (total of 140 shifts during the study period). Seven-day ambient air monitoring of each treatment room was also performed. Methoxyflurane levels adsorbed in each badge sampler were measured by a central laboratory. The primary objective was to evaluate methoxyflurane exposure experience by the hospital ED nurses during an 8-hour shift. RESULTS: In 138 badge samplers, the median (range) concentration of methoxyflurane present following 8-hour nursing shifts was 0.017 (0.008, 0.736) ppm. This level was almost 900-fold lower than the previously reported 8-hour-derived maximal exposure level of 15 ppm; methoxyflurane exposure approaching this threshold was not documented in any badges. There was no correlation between the number of applications of low-dose methoxyflurane administered during a shift (range 0-5) and the vapour exposure measured on the personal badge samplers. CONCLUSIONS: This study indicates that nurses working in hospital EDs experience very low levels of occupational exposure to methoxyflurane vapour during routine clinical practice. These real-world data can provide reassurance to healthcare providers supervising patients receiving low-dose methoxyflurane analgesia via a Penthrox inhaler; further studies may inform exposure in other hospital ED settings.

Pain associated with health and economic burden in France: results from recent National Health and Wellness Survey data.

PURPOSE: This study aimed to estimate the prevalence of pain among French adults and assess the impact of pain on health-related quality of life (HRQoL), activity impairment, and health care resource use (HRU). PATIENTS AND METHODS: Respondents from the 2015 France National Health and Wellness Survey (N=19,173) were categorized by self-reported pain (experienced pain in the past 12 months vs no pain) and compared on HRQoL (36-Item Short Form Health Survey version 2: Mental Component Summary, Physical Component Summary, and Short Form-6 Dimensions health utilities), activity impairment (Work Productivity and Activity Impairment questionnaire), employment status, and HRU (health care provider visits, emergency room visits, and hospitalizations). Bivariate analyses examined differences between pain groups stratified by age, sex, income, and Charlson comorbidity index (CCI) scores. RESULTS: Pain prevalence was 20.2% (n=4007). Mean Physical Component Summary decrements with pain ranged from 3.4 to 8.1 points among those aged <35 years to those aged 45-54 years, respectively. Results for Mental Component Summary and Short Form-6 Dimensions scores followed similar patterns. Regardless of income, sex, or CCI group, pain was associated with significant decrements on all HRQoL measures (for all, p<0.05). The impact of pain on activity impairment was lowest among those <35 years; this impact was higher in middle age and then tapered off among those aged ≥75 years. Pain was associated with greater activity impairment and more health care provider visits across income, sex, and CCI groups (for all, p<0.05). Generally, emergency room visits were more common among those with pain across age, sex, and CCI, but they were only significantly associated with pain in the lower income group (p<0.01). Pain was associated with significantly more hospitalizations across age and income groups. CONCLUSION: Results suggest pain negatively affects HRQoL, activity impairment, and HRU across demographic subgroups. These findings help underscore the considerable health and economic burden of pain in France.