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Simensen, Randi; Fjose, Lars Olav; Rehn, Marius; Hagemo, Jostein Skjalg; Thorsen, Kjetil & Heyerdahl, Fridtjof
(2023).
Comparison of three regimens with inhalational methoxyflurane versus intranasal fentanyl versus intravenous morphine in pre-hospital acute pain management: study protocol for a randomized controlled trial (PreMeFen).
Trials.
ISSN 1745-6215.
24(1).
doi:
10.1186/s13063-023-07590-9.
Vis sammendrag
Background
Pre-hospital pain management has traditionally been performed with intravenous (IV) morphine, but oligoanalgesia remain a recognized problem. Pain reduction is essential for patient satisfaction and is regarded as a measure of successful treatment. We aim to establish whether non-invasive methods such as inhalation of methoxyflurane is non-inferior to intranasal fentanyl or non-inferior to the well-known IV morphine in the pre-hospital treatment of acute pain.
Method/design
The PreMeFen study is a phase three, three-armed, randomized, controlled, non-inferiority trial to compare three regimens of analgesics: inhalation of methoxyflurane and intranasal (IN) fentanyl versus IV morphine. It is an open-label trial with a 1:1:1 randomization to the three treatment groups. The primary endpoint is the change in pain numeric rating scale (NRS) (0–10) from baseline to 10 min after start of investigational medicinal product administration (IMP). The non-inferiority margin was set to 1.3, and a sample size of 270 patients per protocol (90 in each treatment arm) will detect this difference with 90% power.
Discussion
We chose a study design with comparison of analgesic regimens rather than fixed doses because of the substantial differences in drug characteristics and for the results to be relevant to inform policymakers in the pre-hospital setting. We recognize that easier administration of analgesics will lead to better pain management for many patients if the regimens are as good as the existing, and hence, we chose a non-inferiority design. The primary endpoint, the change in pain (NRS) after 10 min, is set to address the immediate need of pain reduction for patients with acute prehospital pain. On a later stage, more analgesic methods are often available.
Summary
PreMeFen is a non-inferiority randomized controlled trial comparing three analgesic regimens aiming to establish whether inhalation of methoxyflurane or intranasal fentanyl is as good as IV morphine for fast reduction of acute pain in the prehospital setting.
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Sigurðsson, Martin Ingi; Chew, Michelle; Olkkola, Klaus T.; Rehn, Marius; Kalliomäki, Maija-Liisa & Møller, Morten Hylander
(2023).
Saudi Critical Care Society clinical practice guidelines on the prevention of venous thromboembolism in adults with trauma: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
doi:
10.1111/aas.14292.
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Brede, Jostein Rødseth; Søvik, Edmund & Rehn, Marius
(2022).
Resuscitative endovascular balloon occlusion of the aorta: the postpartum haemorrhage perspective.
Critical Care.
ISSN 1364-8535.
26.
doi:
10.1186/s13054-022-03942-0.
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Lie, Sole Lindvåg; Hisdal, Jonny; Rehn, Marius & Høiseth, Lars Øivind
(2022).
Effects of supplemental oxygen on systemic and cerebral hemodynamics in experimental hypovolemia: Protocol for a randomized, double blinded crossover study.
PLOS ONE.
ISSN 1932-6203.
17(6).
doi:
10.1371/journal.pone.0270598.
Vis sammendrag
Supplemental oxygen is widely administered in trauma patients, often leading to hyperoxia. However, the clinical evidence for providing supplemental oxygen in all trauma patients is scarce, and hyperoxia has been found to increase mortality in some patient populations. Hypovolemia is a common finding in trauma patients, which affects many hemodynamic parameters, but little is known about how supplemental oxygen affects systemic and cerebral hemodynamics during hypovolemia. We therefore plan to conduct an experimental, randomized, double blinded crossover study to investigate the effect of 100% oxygen compared to room air delivered by a face mask with reservoir on systemic and cerebral hemodynamics during simulated hypovolemia in the lower body negative pressure model in 15 healthy volunteers. We will measure cardiac output, stroke volume, blood pressure, middle cerebral artery velocity and tolerance to hypovolemia continuously in all subjects at two visits to investigate whether oxygen affects the cardiovascular response to simulated hypovolemia. The effect of oxygen on the outcome variables will be analyzed with mixed linear regression.
Trial registration: The study is registered in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT, registration number 2021-003238-35).
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Møller, Morten Hylander; Sigurðsson, Martin Ingi; Olkkola, Klaus T.; Rehn, Marius; Yli-Hankala, Arvi & Chew, Michelle S.
(2022).
Regional anaesthesia in patients on antithrombotic drugs – a joint ESAIC/ESRA guideline: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
66(7),
s. 887–889.
doi:
10.1111/aas.14093.
Fulltekst i vitenarkiv
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Møller, Morten H.; Chew, Michelle S.; Olkkola, Klaus T.; Rehn, Marius; Yli-Hankala, Arvi & Sigurðsson, Martin I.
(2022).
Therapeutics and COVID-19—A living WHO guideline: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
66(5),
s. 636–637.
doi:
10.1111/aas.14046.
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Møller, Morten Hylander; Sigurðsson, Martin Ingi; Olkkola, Klaus T.; Rehn, Marius; Yli-Hankala, Arvi & Chew, Michelle S.
(2022).
Transfusion strategies in bleeding critically ill adults: A clinical practice guideline from the European Society of Intensive Care Medicine: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
s. 1–2.
doi:
10.1111/aas.14047.
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Rehn, Marius; Chew, Michelle S.; Olkkola, Klaus T.; Sigurðsson, Martin Ingi; Yli-Hankala, Arvi & Møller, Morten Hylander
(2021).
Clinical practice guideline on the management of septic shock and sepsis-associated organ dysfunction in children: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
s. 1–2.
doi:
10.1111/aas.13958.
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Yli-Hankala, Arvi; Chew, Michelle S.; Olkkola, Klaus T.; Rehn, Marius; Sverrisson, Kristinn Ö. & Møller, Morten Hylander
(2021).
Clinical practice guideline on spinal stabilisation of adult trauma patients: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
s. 1–2.
doi:
10.1111/aas.13933.
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Rehn, Marius & Lockey, David
(2020).
Early management of multi-trauma.
I Gough, Christopher; Barnett, J & Cook, Tim (Red.),
Challenging concepts in critical care : Cases with expert commentary .
Oxford University Press.
ISSN 9780198814924.
s. 53–65.
doi:
10.1093/med/9780198814924.003.0004.
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Chew, Michelle S.; Rehn, Marius; Olkkola, Klaus T.; Sverrisson, Kristinn Örn; Yli-Hankala, Arvi & Møller, Morten Hylander
(2019).
Clinical practice guideline on prevention of rhabdomyolysis induced acute kidney injury: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
s. 1–2.
doi:
10.1111/aas.13458.
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Rehn, Marius; Chew, Michelle S.; Olkkola, Klaus T.; Sverrison, Kristinn Ö.; Yli-Hankala, Arvi & Møller, Morten Hylander
(2019).
Clinical practice guideline on atraumatic (pencil-point) vs conventional needles for lumbar puncture: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
63,
s. 438–439.
doi:
10.1111/aas.13312.
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Viinamäki, J; Fattah, Sabina; Wisborg, Torben; Rehn, Marius; Engblom, J & Raatiniemi, Lasse
(2018).
Inter-rater reliability of a global major incident reporting template – a pilot study.
Laurea Journal.
-
Fattah, Sabina; Rehn, Marius & Wisborg, Torben
(2018).
Slik kan man lære av katastrofer.
Dagens næringsliv.
ISSN 0803-9372.
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Reid, Bjørn Ole; Haugland, Helge Nystad; Rehn, Marius; Uleberg, Oddvar & Krüger, Andreas
(2018).
Search and rescue compared to remote Medical Evacuation in a Norwegian setting.
-
Nava, Sam; Thompson, Julian & Rehn, Marius
(2018).
ECMO in major trauma: a systematic literature review.
-
Seligmann, William; Dodds, N; Bourn, S; Ray, A; Paulich, S & Rehn, Marius
[Vis alle 7 forfattere av denne artikkelen]
(2018).
A systematic review of blood and CSF biomarkers as early prognosticators in severe traumatic brain injury.
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Rehn, Marius; Chew, Michelle S.; Olkkola, Klaus T.; Sverrison, Kristinn Örn; Yli-Hankala, Arvi & Møller, Morten Hylander
(2018).
Endorsement of clinical practice guidelines by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
63,
s. 161–163.
doi:
10.1111/aas.13306.
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Rehn, Marius; Weaver, AE; Eshelby, Sarah; Røislien, Jo & Lockey, David
(2018).
Pre-hospital transfusion of red blood cells: the role of balanced transfusion protocols and survival bias.
Transfusion Medicine.
ISSN 0958-7578.
doi:
10.1111/tme.12565.
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Hardy, Sophie; Fattah, Sabina; Wisborg, Torben; Raatiniemi, Lasse; Staff, Trine & Rehn, Marius
(2018).
Correction: Systematic reporting to improve the emergency medical response to major incidents: A pilot study.
BMC Emergency Medicine.
ISSN 1471-227X.
18(6).
doi:
10.1186/s12873-018-0157-6.
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Turner, Conor D.A.; Lockey, David & Rehn, Marius
(2017).
Erratum: Pre-hospital management of mass casualty civilian shootings: A systematic literature review[literature review. Crit Care,20 (2016)(362)] DOI:10.1186/s13054-016-1543-7.
Critical Care.
ISSN 1364-8535.
21:94,
s. 1–1.
doi:
10.1186/s13054-017-1663-8.
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Samdal, Martin; Haugland, Helge; Fjeldet, Cato; Rehn, Marius & Sandberg, Mårten
(2017).
Underhengende evakuering med ambulansehelikopter i forbindelse med redningstekniske aksjoner i Helse Sørøst.
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Viinamäki, J; Fattah, Sabina; Jokela, J; Wisborg, T; Rehn, Marius & Engblom, J
(2017).
An inter-rater variability study of a global major incident reporting template: A pilot study.
-
Hardy, S.; Fattah, Sabina; Raatiniemi, Lasse; Staff, T.; Wisborg, T & Rehn, Marius
(2017).
How can systematic reporting improve the emergency medical response to major incidents? A pilot study.
-
Haugland, Helge Nystad; Uleberg, Oddvar; Klepstad, Pål; Krüger, Andreas & Rehn, Marius
(2017).
Kvalitetsmåling i legebemannede utrykningstjenester: en systematisk litteraturgjennomgang.
NAForum.
ISSN 0802-5088.
30(3).
-
Haugland, Helge Nystad; Uleberg, Oddvar; Klepstad, Pål; Krüger, Andreas & Rehn, Marius
(2017).
Kvalitetsmåling i legebemannede utrykningstjenester: en systematisk litteraturgjennomgang.
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Reid, Bjørn Ole; Rehn, Marius; Uleberg, Oddvar; Næss-Pleym, Lars E. & Krüger, Andreas
(2017).
Tverretatlig samhandling i legebemannet luftambulanse tjeneste.
NAForum.
ISSN 0802-5088.
30(3),
s. 44–44.
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Reid, Bjørn Ole; Rehn, Marius; Uleberg, Oddvar; Næss-Pleym, Lars E. & Krüger, Andreas
(2017).
Tverretatlig samhandling i legebemannet luftambulanse tjeneste.
-
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Fattah, Sabina; Rehn, Marius & Wisborg, Torben
(2016).
Field Reports: Yes, They Will Add to the Prehospital and Disaster Knowledge Base.
Prehospital and Disaster Medicine.
ISSN 1049-023X.
31(4).
-
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Tønsager, Kristin & Rehn, Marius
(2015).
Pre-hospital management of mass casualty civilian shootings.
-
Rehn, Marius
(2015).
Mechanism of injury as a predictor of severity of injury in road traffic collisions: a literature review.
-
Rehn, Marius
(2015).
Should we “stay-and-play? A study of patient physiology in Norwegian Helicopter Emergency Services.
-
Rehn, Marius
(2015).
Prehospital håndtering av pediatriske hengninger.
-
Rehn, Marius
(2015).
Londons ́s Air Ambulance: 15 year experience with paediatric hanging.
-
Rehn, Marius
(2015).
Reporting of major incident medical management.
-
Rehn, Marius
(2015).
Implementering og anvendbarhet av en global rapporteringsmal for pre-hospital medisinsk håndtering av større hendelser.
-
Reid, Bjørn Ole; Rehn, Marius; Uleberg, Oddvar & Krüger, Andreas
(2015).
Should we “stay-and-play? A study of patient physiology in Norwegian Helicopter Emergency Services.
-
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Fattah, Sabina; Rehn, Marius; Lockey, David; Thompson, J; Lossius, Hans Morten & Wisborg, Torben
(2013).
A consensus based template for reporting pre-hospital major incident medical management.
Acta Anaesthesiologica Scandinavica.
ISSN 0001-5172.
57,
s. 22–22.
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Rehn, Marius & Sollid, Stephen
(2013).
Retningslinjer for masseskadetriage er etablert.
Tidsskrift for Den norske legeforening.
ISSN 0029-2001.
133(19),
s. 2029–2029.
-
Kristiansen, Thomas; Kristensen, Petter; Gravseth, Hans Magne Ulrik; Rehn, Marius; Røislien, Jo & Søreide, Kjetil
[Vis alle 7 forfattere av denne artikkelen]
(2013).
Epidemiology of trauma: a population-based study of fatal injury and geographical challenges in Norwegian trauma care.
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Kristiansen, Thomas; Rehn, Marius; Gravseth, Hans Magne Ulrik; Lossius, HM & Kristensen, Petter
(2011).
Paediatric trauma mortality in Norway.
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Rehn, Marius & Krüger, Andreas J.
(2010).
Det prehospitale paradoks.
Tidsskrift for Den norske legeforening.
ISSN 0029-2001.
-
Rehn, Marius & Lossius, Hans Morten
(2010).
Katastrofetriage. Behov for en nasjonal standard.
Tidsskrift for Den norske legeforening.
ISSN 0029-2001.
-
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Rehn, Marius; Kristiansen, Thomas; Braarud, Anne-Cathrine; Holtan, Anders; Skaga, Nls Oddvar & Strand, Terje
[Vis alle 9 forfattere av denne artikkelen]
(2010).
Nye triagekriterier: Oslo–Akershus Triage Studie (OATS).
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Kristiansen, Thomas; Rehn, Marius; Braarud, Anne-Cathrine; Holtan, Anders; Skaga, Nls Oddvar & Strand, Terje
[Vis alle 9 forfattere av denne artikkelen]
(2010).
NYE TRIAGEKRITERIER: OSLO–AKERSHUS TRIAGE STUDIE (OATS).
-
Kristiansen, Thomas; Rehn, Marius; Gravseth, Hans Magne Ulrik; Lossius, HM & Kristensen, Petter
(2010).
Injury mortality among Norwegian elderly: 10-year population–based register study.
-
Kristiansen, Thomas; Rehn, Marius; Gravseth, Hans Magne Ulrik; Lossius, HM & Kristensen, Petter
(2010).
Patterns of paediatric trauma deaths: 10-year population–based register study.
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Kristensen, Petter; Kristiansen, Thomas; Rehn, Marius; Gravseth, Hans Magne Ulrik & Bjerkedal, Tor
(2010).
Fatal road traffic injuries at age 16-20 years among 611654 persons born in Norway 1967-1976: multilevel cohort study.
Injury Prevention.
ISSN 1353-8047.
16,
s. A156–A156.
-
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Rehn, Marius; Vigerust, T; Kruger, A & Andersen, John E.
(2010).
Paediatric vital sign tape on stretchers: a field-friendly triage tool?
Emergency Medicine Journal.
ISSN 1472-0205.
27(5),
s. 412–412.
doi:
10.1136/emj.2009.087585.
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Kristensen, Petter; Kristiansen, Thomas; Rehn, Marius; Gravseth, Hans Magne Ulrik & Bjerkedal, Tor
(2010).
Fatal road traffic injuries at age 16-20 years among 611654 persons born in Norway 1967-1976: multilevel cohort study.
-
Krüger, Andreas & Rehn, Marius
(2010).
Early prophylactic hypothermia in severe traumatic brain injury-Challenging a pre-hospital paradigm?
Injury.
ISSN 0020-1383.
41(9),
s. 975–975.
doi:
10.1016/j.injury.2009.09.034.
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Krüger, Andreas & Rehn, Marius
(2010).
Early prophylactic hypothermia in severe traumatic brain injury-Challenging a pre-hospital paradigm?
Injury.
ISSN 0020-1383.
41(7),
s. 1062–1062.
doi:
10.1016/j.injury.2009.09.034.
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Rehn, Marius; Eken, Torsten; Kruger, Andreas; Skaga, Nils Oddvar; Steen, Petter Andreas & Lossius, Hans Morten
(2008).
Upresis felttriage av alvorlig skadde.
-
Rehn, Marius; Eken, Torsten; Kruger, Andreas; Skaga, Nils Oddvar; Steen, Petter Andreas & Lossius, Hans Morten
(2008).
Imprecise field triage of trauma victims.
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Tønsager, Kristin; Krüger, Andreas; Ringdal, Kjetil G. & Rehn, Marius
(2021).
Defining core data for continuous benchmarking in pre-hospital critical care.
Universitetet i Stavanger.