Evidence map›Paper›PMID 32765053›Full record

ArticleJournal of pain research2020

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).

Sossio Serra, Antonio Voza, Germana Ruggiano, Andrea Fabbri, Elisabetta Bonafede, Antonella Sblendido, Amedeo Soldi, Alberto Farina, MEDITA Study Group

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03585374 (Efficacy and Safety of Methoxyflurane Vaporized), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03585374 phase3completednot on this map

Efficacy and Safety of Methoxyflurane Vaporized (PENTHROX®) in the Treatment of Acute Trauma Pain in Pre-hospital Setting and in the Emergency Department in Italy: a Multicentre, Randomized, Controlled, Open-label Study

TypeinterventionalSponsorMundipharma Pharmaceuticals srlRan2018 to 2019Enrolled272ConditionsAcute Traumatic PainArmsMethoxyflurane and Penthrox inhaler, Morphine, Paracetamol, Ketoprofen
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Observational
  4. Observational
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Sossio SerraEmergency Department, Maurizio Bufalini Hospital, Cesena, Italy.
Antonio VozaEmergency Department, IRCCS Humanitas Research Teaching Hospital, Rozzano, Milan, Italy.ORCID 0000-0001-7309-6929
Germana RuggianoEmergency Medicine Department, Santa Maria Annunziata Hospital, Florence, Italy.
Andrea FabbriDepartment of Emergency Medicine, Morgagni-Pierantoni Hospital, Forlì, Italy.ORCID 0000-0002-9837-4638
Elisabetta BonafedeYGHEA, CRO Division of Ecol Studio Bioikos S.r.l., Bologna, Italy.ORCID 0000-0002-3509-089X
Antonella SblendidoMedical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.
Amedeo SoldiMedical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.ORCID 0000-0002-4021-4463
Alberto FarinaMedical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.ORCID 0000-0003-1896-1179
MEDITA Study Group
IRCCS Humanitas Research Hospital · ITOspedale G.B. Morgagni - L.Pierantoni · ITOspedale “M. Bufalini” di Cesena · ITOspedale Santa Maria Annunziata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAcute 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

methodsSubgroup, 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.

resultsPain 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.

conclusionIn 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 registrationEudraCT number: 2017-001565-25; Clinicaltrials.gov identifier NCT03585374.

Indexed as

acute painanalgesiaelderlyemergency departmentmethoxyfluraneprehospitaltrauma

Identifiers

PMID32765053
PMCPMC7371437
OpenAlexW3042321356

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.