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Methoxyflurane versus usual Analgesia for Prehospital Injury & Trauma

  • Research type

    Research Study

  • Full title

    Pragmatic cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of inhaled Methoxyflurane (Penthrox) versus usual Analgesia for Prehospital acute Injury and Trauma (MAPIT)

  • IRAS ID

    236062

  • Contact name

    Alyosius Niroshan Siriwardena

  • Contact email

    Niro.siriwardena@emas.nhs.uk

  • Sponsor organisation

    East Midlands Ambulance Service NHS Trust

  • Eudract number

    2017-004156-38

  • Duration of Study in the UK

    0 years, 6 months, 31 days

  • Research summary

    Inhaled methoxyflurane has been used safely by prehospital ambulance staff in Australia over the past 40 years for treatment of patients with moderate to severe acute pain due to injury or trauma. This drug is now being promoted for use in United Kingdom (UK) ambulance services but evidence is lacking from randomised controlled trials of clinical effectiveness of methoxyflurane compared with current treatments which include intravenous or oral morphine (or other opiates), intravenous paracetamol or nitrous oxide – oxygen (1:1) mixture. Of these analgesics only Entonox can be administered by Emergency Medical Technicians as usual analgesia.

    We aim to investigate the clinical and cost effectiveness of methoxyflurane in adults presenting for treatment to ambulance services with moderate to severe acute pain due to trauma or injury.

    The study will take place in one or more counties served by East Midlands Ambulance Service NHS Trust (EMAS). Participants will consist of paramedics and Emergency Medical Technicians (EMTs) attending adult patients with moderate to severe pain due to injury or trauma.

    Adults aged 18 years and above with a verbal numerical pain score (VNPS) of 4 or above (4-10) due to injury/trauma attended by one or more ambulance clinicians (paramedic or EMT) trained in the study procedures will be eligible. Exclusion criteria will include children aged <18 years, GCS<15, hypersensitivity to methoxyflurane or other fluorinated anaesthetic, previous dose within 24 hours, renal failure, liver failure, sickle cell disease, cardiovascular instability, respiratory depression, pregnancy or breastfeeding.

    Outcomes will be collected from routine ambulance service data. Patients will not receive any additional research activity procedures. The primary outcome will be a difference in pain score taken at baseline, pain within 5 minutes after administration of analgesic and final pain score (i.e. after 30 minutes or arrival at ED) whichever is soonest OR administration of an additional analgesic.

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference

    18/EM/0002

  • Date of REC Opinion

    5 Feb 2018

  • REC opinion

    Unfavourable Opinion