Prehospital Analgesia in Adults Using Inhaled Methoxyflurane Study

NCT06392087 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 20240319100
• Study Type: interventional
• Target: 1,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is about a new pain relief medication called methoxyflurane. Pain from injuries, like broken bones, is a big reason people call ambulances. It's important to treat pain well because it can make people sick and slow down healing. But often, pain isn't treated enough, which can lead to more problems. Paramedics use different drugs to manage pain, but some are hard to give and need special training and equipment. Methoxyflurane is a new option. It's a gas you breathe in through a special inhaler. It's been used in Australia and New Zealand for a long time and has shown to work quickly and safely for different kinds of pain. This study wants to see if methoxyflurane works well for people with moderate to severe pain from injuries compared to other medicines like Advil, Tylenol and opioids. It's testing if methoxyflurane can give fast pain relief and if paramedics find it easy to use. The study will help understand if methoxyflurane could be a good option for treating pain in ambulances.

Conditions

Pain, Acute

Keywords

paramedic; traumatic pain; Ambulance

Outcome Measures

Primary Outcomes (1)

• Verbal Numeric Pain Score

  verbal numeric pain rating score (NPRS) initial and at 10 min, 0 referring to no pain and 10 severe pain

  10 min

Secondary Outcomes (5)

• Rescue Medications

  10 min

• Transport Time

  8 months

• Time to first analgesia

  8 months

• Vital signs

  5 min

• Verbal numeric pain score during care

  5 min

Other Outcomes (1)

• Adverse events

  8 months

Study Arms (2)

Control standard care

ACTIVE COMPARATOR

The patients who meet the indications of the study trauma-related pain Moderate/Severe (\>4 verbal numeric pain score), are provided current standard of care for pain (Advil or Ketorolac/Tylenol, opioids (for Advanced Care paramedics)

Other: Standard Care

Intervention

EXPERIMENTAL

The patients who meet the indications of the study trauma-related pain Moderate/Severe (\>4 verbal numeric pain score) and receive methoxyflurane

Drug: Methoxyflurane

Interventions

Methoxyflurane DRUG

Patients ≥ 18 years of age (using a waiver of consent process) Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS) traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention) Unaltered (Glasgow Coma Scale (GCS) ≥ 14) Normotensive (systolic blood pressure ≥100) Treated and transported

Also known as: Penthrox

Intervention

Standard Care OTHER

Patients ≥ 18 years of age (using a waiver of consent process) Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS) traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention) Unaltered (Glasgow Coma Scale (GCS) ≥ 14) Normotensive (systolic blood pressure ≥100) Treated and transported

Control standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indications for analgesia therapy:
• Patients ≥ 18 years of age (using a waiver of consent process)
• Pain score ≥ 4 on the verbal numeric pain rating scale (NPRS)
• traumatic injury (defined as: physical injuries of sudden onset and severity which requires immediate medical attention)
• Unaltered (Glasgow Coma Scale (GCS) ≥ 14)
• Normotensive (systolic blood pressure ≥100)
• Treated and transported
• Paramedics will follow the Advanced Life Support Patient Care Standards21 for all other care the patient requires (including pain directive if methoxyflurane does not control pain after 10 min).
• Contraindications listed in the ALS-PCS will be used by paramedics in providing analgesia. Within the standards paramedics are required to record vital signs every 5 minutes including verbal NPRS.

You may not qualify if:

• Patients with the following characteristics will be excluded (based on the Health Canada Product Monograph):
• History or family history of malignant hyperthermia
• Age \<18 years of age
• Pregnancy or breast-feeding
• Known renal impairment
• Known liver disease
• History of use of methoxyflurane in the last 3 months
• Allergy to methoxyflurane

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Methoxyflurane; Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Michael A Austin, MD

CONTACT

6132970327; maustin@toh.ca

Jane Marchand

CONTACT

6137377228; jamarchand@rppeo.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step Wedge Design

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 30, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07