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Methoxyflurane versus usual Analgesia for Prehospital Injury & Trauma

Pragmatic cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of inhaled methoxyflurane (Penthrox) versus usual analgesia for prehospital injury and trauma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24016440
Enrollment
1040
Registered
2018-01-08
Start date
2017-12-01
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-hospital pain management for patients in moderate to sever pain from injury or trauma Signs and Symptoms

Interventions

Ambulance clinicians will be randomised following initial training on trial procedures. Paramedics and EMTs will be allocated into two equal blocks, and individuals in each block randomised into inter

Sponsors

East Midlands Ambulance Service NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ambulance staff: 1. Qualified Paramedic or Emergency Medical Technician contracted by East Midlands Ambulance Service NHS Trust Patients: 1. Adult aged 18 years and above 2. Emergency attendance by ambulance paramedic or EMT 3. In moderate to severe pain (VNPS 4-10) due to trauma (injury) and associated pain

Exclusion criteria

Exclusion criteria: Ambulance staff: 1 East Midlands Ambulance Service NHS Trust staff who are pregnant or breastfeeding Patients: 1. Child or young person aged under 18 years 2. Altered level of consciousness (Glasgow Coma Scale [GCS] <15) due to any cause including head injury, drugs, or alcohol 3. Suspected cardiac chest pain, sickle cell crisis 4. Hypersensitivity to methoxyflurane or any fluorinated anaesthetic 5. Malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives 6. History of showing signs of liver damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia 7. Clinically significant renal impairment 8. Clinically evident cardiovascular instability 9. Clinically evident respiratory depression 10. Pregnancy and females who are breastfeeding

Design outcomes

Primary

MeasureTime frame
Pain measured using the verbal numerical pain score (VNPS), which is used as standard method of assessment for all patients attended by East Midlands Ambulance Service NHS Trust. Baseline pain scores will be taken as standard prior to the administration of any analgesia, 5 minutes after initial analgesia and again at 30 minutes or arrival at the emergency department whichever is sooner.

Secondary

MeasureTime frame
1. Incremental cost effectiveness ratio (including the drug costs, costs of associated consumables, cylinder rental, number cylinders used, refilling and maintenance costs (regarding Entonox) in addition to requirements for duplication of resources at scene (i.e. EMT crew having to call paramedic back-up for purposes of stronger analgesic requirements) and also the necessity to take the patient to ED if given an opioid) 2. Tolerability of methoxyflurane 3. Proportion of patients in whom pain between baseline, pain 5 minutes after administration and at final (i.e. after 30 minutes or at arrival at ED) is reduced 4. Time to addition of second analgesic versus current standard of care (Entonox) 5. Percentage of patients with a = 30% reduction in baseline pain at first and subsequent timepoints/measurements

Countries

United Kingdom

Contacts

Public ContactTanya Payne
Tanya.payne@emas.nhs.uk+44 (0)1522 832640

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026