Evidence map›Paper›PMID 32184653›Full record

ArticleJournal of pain research2020

Inhaled Methoxyflurane versus Intravenous Morphine for Severe Trauma Pain in the Emergency Setting: Subgroup Analysis of MEDITA, a Multicenter, Randomized, Controlled, Open-Label Trial.

Antonio Voza, Germana Ruggiano, Sossio Serra, Giuseppe Carpinteri, Gianfilippo Gangitano, Fabio Intelligente, Elisabetta Bonafede, Antonella Sblendido, Alberto Farina, Amedeo Soldi and 2 more

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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Article
  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

12 authors at 7 institutions in 1 country.

Antonio VozaEmergency Department, IRCCS Humanitas Research Teaching Hospital, Milan, Italy.ORCID 0000-0001-7309-6929
Germana RuggianoEmergency Medicine Department, Santa Maria Annunziata Hospital, Florence, Italy.
Sossio SerraEmergency Department, Maurizio Bufalini Hospital, Cesena, Italy.
Giuseppe CarpinteriDepartment of Emergency Medicine, Policlinico G. Rodolico University Hospital, Catania, Italy.ORCID 0000-0001-9280-9621
Gianfilippo GangitanoEmergency Department, Infermi Hospital, Rimini, Italy.
Fabio IntelligenteEmergency Department, IRCCS Humanitas Research Teaching Hospital, Milan, Italy.
Elisabetta BonafedeYGHEA, Division of Ecol Studio s.p.a., Bologna, Italy.
Antonella SblendidoMedical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.
Alberto FarinaMedical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.ORCID 0000-0003-1896-1179
Amedeo SoldiMedical Affairs Department, Mundipharma Pharmaceuticals Srl, Milan, Italy.ORCID 0000-0002-4021-4463
Andrea FabbriDepartment of Emergency Medicine, Morgagni-Pierantoni Hospital, Forlì, Italy.ORCID 0000-0002-9837-4638
MEDITA Study Group
IRCCS Humanitas Research Hospital · ITNational Agency for New Technologies, Energy and Sustainable Economic Development · ITOspedale G.B. Morgagni - L.Pierantoni · ITOspedale Infermi di Rimini · ITOspedale “M. Bufalini” di Cesena · ITOspedale Santa Maria Annunziata · ITPoliclinico Universitario di Catania · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOpioid analgesics remain the cornerstone of treatment for severe trauma pain in the emergency setting, but there are barriers to their use. This post hoc analysis of a previously reported trial (MEDITA) investigated the efficacy and safety of low-dose methoxyflurane versus intravenous (IV) morphine for severe trauma pain. PATIENTS AND

methodsMEDITA was a Phase IIIb, randomized, active-controlled, parallel-group, open-label study in Italian pre-hospital units and emergency departments (EudraCT: 2017-001565-25; NCT03585374). Adult patients (N=272) with moderate-to-severe trauma pain (score ≥4 on the Numerical Rating Scale [NRS]) were randomized 1:1 to inhaled methoxyflurane (3 mL) or standard analgesic treatment (SAT; IV paracetamol 1g or ketoprofen 100mg for moderate pain [NRS 4-6] and IV morphine 0.1mg/kg for severe pain [NRS ≥7]). Analyses were performed for the severe pain subgroup. The primary efficacy variable was the overall change from baseline in visual analog scale (VAS) pain intensity at 3, 5 and 10min post-randomization. Non-inferiority of methoxyflurane versus morphine was concluded if the upper 95% confidence interval (CI) for the treatment difference was <1; superiority was concluded if the upper 95% CI was <0.

resultsNinety-three patients (methoxyflurane: 49; SAT: 44) were included in the severe pain intention-to-treat population. The reduction in VAS pain intensity over the first 10min was superior for methoxyflurane versus morphine (adjusted mean treatment difference: -5.54mm; 95% CI: -10.49, -0.59mm; p=0.029). Median time to onset of pain relief was 9min for methoxyflurane and 15min for morphine. Patients rated treatment efficacy and physicians rated treatment practicality "Excellent" or "Very good" for more methoxyflurane-treated patients (42.8% and 67.3%) than morphine-treated patients (18.1% and 22.8%). Adverse events, all non-serious, were reported in 20.4% of methoxyflurane-treated patients and in 4.8% of morphine-treated patients.

conclusionMethoxyflurane provided superior short-term pain relief to IV morphine in patients with severe trauma pain and offers an effective non-narcotic treatment option.

Indexed as

acute painanalgesicemergency departmentmethoxyfluranemorphineprehospital

Identifiers

PMID32184653
PMCPMC7064290
OpenAlexW3010459672

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.