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Prospective, Multicentre Trial of Methoxyflurane for Acute Trauma-Related Pain in Helicopter Emergency Medical Systems and Hostile Environments: METEORA Protocol.

ABSTRACT: INTRODUCTION:The inhalational analgesic low-dose methoxyflurane has been widely used by Australian ambulance services since 1975 and is now approved in Europe for emergency relief of moderate-to-severe trauma-related pain in conscious adult patients. The use of methoxyflurane in hostile environments is of special interest given its portability, ease of use and rapid onset of action. This trial will investigate the efficacy, tolerability and practicality of use of inhaled methoxyflurane in patients with moderate-to-severe trauma-related pain rescued from hostile mountainous environments by the Helicopter Emergency Medical Service (HEMS) in Italy. METHODS:METEORA is a phase IIIb, prospective, single-arm, multicentre trial. Approximately 200 adult patients with a pain score of at least 4 on the numerical rating scale (NRS) due to limb trauma rescued by HEMS will be enrolled. Patients will receive up to 2?×?3 mL methoxyflurane, self-administered by the patient by inhalation under medical supervision. Rescue medication will be permitted if required. PLANNED OUTCOMES:Pain intensity will be measured using a 100-mm visual analogue scale (VAS) at baseline, at 5, 10, 15, 20, 30, 45 and 60 min after the start of methoxyflurane inhalation and when positioning the patient on a spinal board or stretcher; and also using the NRS at enrolment and at 10 min. Use of rescue medication (yes/no) will be recorded. The patient will rate efficacy and the healthcare professional will rate practicality of methoxyflurane treatment at 30 and 60 min using a 5-point Likert scale. Vital signs will be measured at baseline, 10, 30 and 60 min. Assessments after 30 min will only be performed for patients using a second inhaler. Adverse events will be recorded until safety follow-up at 3?±?1 days. The primary endpoint is the percentage of patients achieving at least 30% improvement from baseline in VAS pain intensity within the first 10 min of methoxyflurane administration. TRIAL REGISTRATION:EudraCT number: 2017-004601-40. FUNDING:Mundipharma Pharmaceuticals, srl. Plain language summary available for this article.

SUBMITTER: Marinangeli F

PROVIDER: S-EPMC6223977 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Prospective, Multicentre Trial of Methoxyflurane for Acute Trauma-Related Pain in Helicopter Emergency Medical Systems and Hostile Environments: METEORA Protocol.

Marinangeli Franco F Reggiardo Giorgio G Sblendido Antonella A Soldi Amedeo A Farina Alberto A

Advances in therapy 20181029 11

<h4>Introduction</h4>The inhalational analgesic low-dose methoxyflurane has been widely used by Australian ambulance services since 1975 and is now approved in Europe for emergency relief of moderate-to-severe trauma-related pain in conscious adult patients. The use of methoxyflurane in hostile environments is of special interest given its portability, ease of use and rapid onset of action. This trial will investigate the efficacy, tolerability and practicality of use of inhaled methoxyflurane i ...[more]

PMID: 30374805

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Project description:Despite numerous studies on prehospital airway management, results are difficult to compare due to inconsistent or heterogeneous data. The objective of this study was to assess advanced airway management from international physician-staffed helicopter emergency medical services.We collected airway data from 21 helicopter emergency medical services in Australia, England, Finland, Hungary, Norway and Switzerland over a 12-month period. A uniform Utstein-style airway template was used for collecting data.The participating services attended 14,703 patients on primary missions during the study period, and 2,327 (16 %) required advanced prehospital airway interventions. Of these, tracheal intubation was attempted in 92 % of the cases. The rest were managed with supraglottic airway devices (5 %), bag-valve-mask ventilation (2 %) or continuous positive airway pressure (0.2 %). Intubation failure rates were 14.5 % (first-attempt) and 1.2 % (overall). Cardiac arrest patients showed significantly higher first-attempt intubation failure rates (odds ratio: 2.0; 95 % CI: 1.5-2.6; p?<?0.001) compared to non-cardiac arrest patients. Complications were recorded in 13 %, with recognised oesophageal intubation being the most frequent (25 % of all patients with complications). For non-cardiac arrest patients, important risk predictors for first-attempt failure were patient age (a non-linear association) and administration of sedatives (reduced failure risk). The patient's sex, provider's intubation experience, trauma type (patient category), indication for airway intervention and use of neuromuscular blocking agents were not risk factors for first-attempt intubation failure.Advanced airway management in physician-staffed prehospital services was performed frequently, with high intubation success rates and low complication rates overall. However, cardiac arrest patients showed significantly higher first-attempt failure rates compared to non-cardiac arrest patients. All failed intubations were handled successfully with a rescue device or surgical airway.www.clinicaltrials.gov NCT01502111 . Registered 22 December 2011.

Project description:BackgroundDespite evidence of benefit after injury, helicopter emergency medical services (HEMS) overtriage remains high. Scene and transfer overtriage are distinct processes. Our objectives were to identify geographic variation in overtriage and patient-level predictors, and determine if overtriage impacts population-level outcomes.MethodsPatients 16 years or older undergoing scene or interfacility HEMS in the Pennsylvania Trauma Outcomes Study were included. Overtriage was defined as discharge within 24 hours of arrival. Patients were mapped to zip code, and rates of overtriage were calculated. Hot spot analysis identified regions of high and low overtriage. Mixed-effects logistic regression determined patient predictors of overtriage. High and low overtriage regions were compared for population-level injury fatality rates. Analyses were performed for scene and transfer patients separately.ResultsA total of 85,572 patients were included (37.4% transfers). Overtriage was 5.5% among scene and 11.8% among transfer HEMS (p < 0.01). Hot spot analysis demonstrated geographic variation in high and low overtriage for scene and transfer patients. For scene patients, overtriage was associated with distance (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.06 per 10 miles; p = 0.04), neck injury (OR, 1.27; 95% CI, 1.01-1.60; p = 0.04), and single-system injury (OR, 1.37; 95% CI, 1.15-1.64; p < 0.01). For transfer patients, overtriage was associated with rurality (OR, 1.64; 95% CI, 1.22-2.21; p < 0.01), facial injury (OR, 1.22; 95% CI, 1.03-1.44; p = 0.02), and single-system injury (OR, 1.35; 95% CI, 1.18-2.19; p < 0.01). For scene patients, high overtriage was associated with higher injury fatality rate (coefficient, 1.72; 95% CI, 1.68-1.76; p < 0.01); low overtriage was associated with lower injury fatality rate (coefficient, -0.73; 95% CI, -0.78 to -0.68; p < 0.01). For transfer patients, high overtriage was not associated with injury fatality rate (p = 0.53); low overtriage was associated with lower injury fatality rate (coefficient, -2.87; 95% CI, -4.59 to -1.16; p < 0.01).ConclusionGeographic overtriage rates vary significantly for scene and transfer HEMS, and are associated with population-level outcomes. These findings can help guide targeted performance improvement initiatives to reduce HEMS overtriage.Level of evidenceTherapeutic, level IV.

Project description:BACKGROUND:Making ethically sound treatment limitations in prehospital care is a complex topic. Helicopter Emergency Medical Service (HEMS) physicians were surveyed on their experiences with limitations of care orders in the prehospital setting, including situations where they are dispatched to healthcare facilities or nursing homes. METHODS:A nationwide multicentre study was conducted among all HEMS physicians in Finland in 2017 using a questionnaire with closed five-point Likert-scale questions and open questions. The Ethics Committee of the Tampere University Hospital approved the study protocol (R15048). RESULTS:Fifty-nine (88%) physicians responded. Their median age was 43 (IQR 38-47) and median medical working experience was 15 (IQR 10-20) years. All respondents made limitation of care orders and 39% made them often. Three fourths (75%) of the physicians were often dispatched to healthcare facilities and nursing homes and the majority (93%) regularly met patients who should have already had a valid limitation of care order. Every other physician (49%) had sometimes decided not to implement a medically justifiable limitation of care order because they wanted to avoid conflicts with the patient and/or the next of kin and/or other healthcare staff. Limitation of care order practices varied between the respondents, but neither age nor working experience explained these differences in answers. Most physicians (85%) stated that limitations of care orders are part of their work and 81% did not find them especially burdensome. The most challenging patient groups for treatment limitations were the under-aged patients, the severely disabled patients and the patients in healthcare facilities or residing in nursing homes. CONCLUSION:Making limitation of care orders is an important but often invisible part of a HEMS physician's work. HEMS physicians expressed that patients in long-term care were often without limitations of care orders in situations where an order would have been ethically in accordance with the patient's best interests.

Project description:BACKGROUND:Acute trauma pain is poorly managed in the emergency department (ED). The reasons are partly organizational: ED crowding and rare trauma care pathways contribute to oligoanalgesia. Anticipating the organizational impact of an innovative care procedure might facilitate the decision-making process and help to optimize pain management. METHODS:We used a multiple criteria decision analysis (MCDA) approach to consider the organizational impact of methoxyflurane (self-administered) in the ED, introduced alone or supported by a trauma care pathway. A MCDA experiment was designed for this specific context, 8 experts in emergency trauma care pathways (leading physicians and pharmacists working in French urban tertiary hospitals) were recruited. The study involved four steps: (i) Selection of organizational criteria for evaluating the innovation's impact; (ii) assessment of the relative weight of each criterion; (iii) choice of appropriate scenarios for exploring the organizational impact of MEOX under various contexts; and (iv) software-assisted simulation based on pairwise comparisons of the scenarios. The final outcome measure was the expected overall organizational impact of methoxyflurane on a 0-to-100 scale (score >50: positive impact). RESULTS:Nine organizational criteria were selected. "Mean length of stay in the ED" was the most weighted. Methoxyflurane alone obtained 59 as a total score, with a putative positive impact for eight criteria, and a neutral effect on one. When a trauma care pathway was introduced concomitantly, the impact of methoxyflurane was greater overall (score: 75) and for each individual criterion. CONCLUSIONS:Our model highlighted the putative positive organizational impact of methoxyflurane in the ED-particularly when supported by a trauma care pathway-and the relevance of expert consensus in this particular pharmacoeconomic context. The MCDA approach could be extended to other research fields and healthcare challenges in emergency medicine.

Project description:IntroductionInhaled low-dose methoxyflurane is approved in Europe for emergency relief of moderate-to-severe trauma-related pain in adults, but data versus active comparators are sparse. The phase IIIb Methoxyflurane in Emergency Department in ITAly (MEDITA) trial investigated the analgesic efficacy, practicality and safety of methoxyflurane versus standard analgesic treatment (SAT) for acute trauma pain.MethodsThis was a randomised, active-controlled, parallel-group, open-label trial conducted in 15 Italian emergency units. Adults with limb trauma and pain score ≥ 4 on numerical rating scale (NRS) were randomised 1:1 to inhaled methoxyflurane 3 mL or SAT [intravenously administered (IV) morphine 0.1 mg/kg for severe pain (NRS ≥ 7); IV paracetamol 1 g or IV ketoprofen 100 mg for moderate pain (NRS 4-6)]. The primary endpoint was overall change in visual analogue scale (VAS) pain intensity from baseline (time of randomisation) to 3, 5 and 10 min. Non-inferiority and superiority of methoxyflurane versus SAT were concluded if the upper 95% confidence interval (CI) for the treatment comparison (methoxyflurane-SAT) was less than 1 and less than 0, respectively.ResultsBetween 8 February 2018 and 8 February 2019, 272 patients were randomised (136 per treatment group). A total of 270 patients (mean age 51 years; 49% male; 34% with severe pain; mean baseline VAS 67 mm) were treated and analysed for efficacy and safety. Superiority of methoxyflurane was demonstrated for moderate-to-severe pain (adjusted mean treatment difference - 5.94 mm; 95% CI - 8.83, - 3.06 mm), moderate pain (- 5.97 mm; 95% CI - 9.55, - 2.39 mm) and severe pain (- 5.54 mm; 95% CI - 10.49, - 0.59 mm). Median onset of pain relief was 9 min for methoxyflurane and 15 min for SAT. Practicality of methoxyflurane treatment was rated "Excellent", "Very Good" or "Good" by 90% of clinicians vs. 64% for SAT. Adverse events (all non-serious) were reported by 17% of methoxyflurane-treated patients and 3% of SAT-treated patients.ConclusionMethoxyflurane provided superior pain relief to SAT in patients with moderate-to-severe trauma pain and may offer a simple, fast, effective non-opioid treatment option.Trial registrationTrial registered with EudraCT (2017-001565-25) on 2 March 2018 and ClinicalTrials.gov (NCT03585374) on 13 July 2018.FundingMundipharma Pharmaceuticals S.r.l.

Dataset Information

Prospective, Multicentre Trial of Methoxyflurane for Acute Trauma-Related Pain in Helicopter Emergency Medical Systems and Hostile Environments: METEORA Protocol.

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Prospective, Multicentre Trial of Methoxyflurane for Acute Trauma-Related Pain in Helicopter Emergency Medical Systems and Hostile Environments: METEORA Protocol.

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