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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).
Simensen, Randi; Fjose, Lars Olav; Rehn, Marius; Hagemo, Jostein; Thorsen, Kjetil; Heyerdahl, Fridtjof.
Affiliation
  • Simensen R; Division of Pre-Hospital Services, Innlandet Hospital Trust, Kastbakkvegen 9, 2390, Moelv, Norway. randi.simensen@norskluftambulanse.no.
  • Fjose LO; Department of Research, Norwegian Air Ambulance Foundation, Oslo, Norway. randi.simensen@norskluftambulanse.no.
  • Rehn M; Division of Pre-Hospital Services, Oslo University Hospital, Oslo, Norway. randi.simensen@norskluftambulanse.no.
  • Hagemo J; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. randi.simensen@norskluftambulanse.no.
  • Thorsen K; Division of Pre-Hospital Services, Innlandet Hospital Trust, Kastbakkvegen 9, 2390, Moelv, Norway.
  • Heyerdahl F; Department of Research, Norwegian Air Ambulance Foundation, Oslo, Norway.
Trials ; 24(1): 571, 2023 Sep 05.
Article in En | MEDLINE | ID: mdl-37670364
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. 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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Full text: 1 Collection: 01-internacional Health context: 8_ODS3_consumo_sustancias_psicoactivas Database: MEDLINE Main subject: Acute Pain Type of study: Clinical_trials / Guideline Limits: Humans Language: En Journal: Trials Year: 2023 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 8_ODS3_consumo_sustancias_psicoactivas Database: MEDLINE Main subject: Acute Pain Type of study: Clinical_trials / Guideline Limits: Humans Language: En Journal: Trials Year: 2023 Document type: Article