Methoxyflurane versus usual Analgesia for Prehospital Injury & Trauma

Phase 3

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

• Registration Number: ISRCTN24016440
• Lead Sponsor: East Midlands Ambulance Service NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-08
• Study Completion: 2018-06-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 1040

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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)<br> 2. Tolerability of methoxyflurane<br> 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<br> 4. Time to addition of second analgesic versus current standard of care (Entonox)<br> 5. Percentage of patients with a = 30% reduction in baseline pain at first and subsequent timepoints/measurements<br>