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Efficacy, Practicality, and Safety of Inhaled Methoxyflurane in Elderly Patients with Acute Trauma Pain: Subgroup Analysis of a Randomized, Controlled, Multicenter, Open-Label Trial (MEDITA)

Jul 15, 2020

Tel +39 02 3182881 Email alberto.farina@mundipharma.it Purpose: Acute trauma pain management in the elderly population is a challenge. Inhaled methoxyflurane represents a promising treatment option; however, data in the elderly population are limited. Patients and Methods: Subgroup, post hoc analysis including 69 patients aged ≥ 65 years from a randomized, active-controlled, open-label study in the emergency setting. Key inclusion criterion was moderate-to-severe pain (Numerical Rating Scale [NRS] score ≥ 4]) secondary to trauma in a single limb. Patients received inhaled methoxyflurane (3 mL) or standard analgesic treatment (SAT; IV paracetamol 1 g or ketoprofen 100 mg for moderate pain [NRS 4– 6] and IV morphine 0.1mg/kg for severe pain [NRS ≥ 7]). The primary endpoint was the overall change in visual analog scale (VAS) pain intensity from randomization to the next 3, 5, and 10 min. Secondary endpoints included time to onset of pain relief (TOPR), efficacy up to 30 min, judgment of operators and patients, and safety. Results: Pain reduction over time was similar in both groups. Median TOPR was shorter for methoxyflurane (9 min; 95% CI: 7.8, 10.2 min) than SAT (15 min; 95% CI: 10.2, 19.8 min). In terms of treatment satisfaction, patients and operators rated treatment efficacy and practicality, respectively, as “Excellent” or “Very good” 5.7 times and 3.4 times more frequently than SAT. A similar rate of adverse events (methoxyflurane: 6 events; SAT: 7 events) was recorded, all non-serious. No clinically significant changes in vital signs parameters were observed, and methoxyflurane did not result in cases of bradycardia or hypotension. Conclusion: In elderly patients with trauma pain, inhaled methoxyflurane shows similar pain relief and safety compared to SAT, offering advantages in terms of onset of effect and user’s satisfaction. Although this analysis presents some methodological limitations, it provides the first specific evidence of the use of inhaled methoxyflurane in the elderly population. Trial Registration: EudraCT number: 2017-001565-25; Clinicaltrials.gov identifier NCT03585374. Keywords: acute pain, trauma, elderly, analgesia, emergency department, methoxyflurane, prehospital This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License . By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms .

MEDITA Investments

1 Investments

MEDITA has made 1 investments. Their latest investment was in 2010 Perfect Vision as part of their Other Investors on .

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MEDITA Investments Activity

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MEDITA Team

1 Team Member

MEDITA has 1 team member, including former Owner, Stefano Di Persio.

Name

Work History

Title

Status

Stefano Di Persio

Owner

Former

Name

Stefano Di Persio

Work History

Title

Owner

Status

Former

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