Prehospital Inhaled Methoxyflurane Non-Clinical Occupational Exposure Study

NCT05766397 | Enrolling By Invitation Phase 4

• 1 other identifier: CRRF 4869
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Methoxyflurane is an anesthetic gas and at low doses has shown to help with pain. Methoxyflurane was approved in Canada in 2018. Low-dose methoxyflurane is self-administered by patients via a handheld inhaler. Exhaled methoxyflurane is captured by an activated carbon (AC) chamber fitted to the inhaler in order to minimize environmental and occupational exposure. It provides rapid (\<1 minute), short-term (30-45 minutes) pain relief within six to ten inhalations and has been shown to be effective and safe in emergency care and for minor surgical, radiological, and dental procedures. The current dosing recommendation is 3 ml bottle. However, the frequency at which methoxyflurane treatment can be safely used by paramedics is not established. From the product monograph, a patient's maximum daily dose of 6 mLs and weekly 15 mLs of methoxyflurane. The treatment course of methoxyflurane for patients should not be repeated at an interval of less than 3 months. Despite the activated carbon chamber to capture the exhaled methoxyflurane, when paramedics are supervising patients receiving inhaled analgesia within a confined area (like the back of an ambulance), it is possible that a paramedic may experience intermittent exposure to methoxyflurane vapour. Multiple use of the methoxyflurane Inhaler, with or without the AC chamber, creates additional risk. Elevation of liver enzymes, blood urea nitrogen, and serum uric acid, have been reported in healthcare professionals regularly exposed to methoxyflurane inhalational products. 8 A formal limit regarding levels of occupational exposure to methoxyflurane has not been established. The risk of occupational exposure of methoxyflurane will be evaluated in a controlled laboratory setting, recruiting 30 health, screened (history and blood work) volunteers to participate in the back of an ambulance which meets the Ontario Ministry of Health Standards. The participants will consent and follow a protocol while active samplers are placed in the rear of the ambulance to capture the off-gassing of the methoxyflurane. This will inform the risk of occupational exposure of methoxyflurane to paramedics, as well as, hoping to inform the risk of multiple administrations by paramedics to different patients during a single shift, to ensure a medical directive can be created to support patient care and evaluate and support paramedic safety.

Conditions

Occupational Exposure

Keywords

paramedic; occupational exposure

Outcome Measures

Primary Outcomes (2)

• 8 hour Time weighted average

  Eight-hour time weighted average (TWA) for methoxyflurane exposure level following a single participant protocol (1 event)

  15 minutes

• 8 hour time weighted average

  Eight-hour TWA for methoxyflurane exposure resulting from multiple participant protocols (multiple events)

  120 minutes

Secondary Outcomes (12)

• 8 hour time weighted average

  15 minutes

• 8 hour time weighted average

  15 minutes

• adverse events

  60 minutes

• vital signs for participants

  60 minutes (5 minute interval)

• vital signs for participants

  60 minutes (5 minute interval)

Other Outcomes (2)

• environmental factors

  15 minutes

• environmental factors

  15 minutes

Study Arms (1)

Health volunteer

OTHER

Health volunteers will follow a standard protocol for inhalation of methoxyflurane while the off-gassing will be captured.

Drug: Methoxyflurane

Interventions

Methoxyflurane DRUG

Methoxyflurane belongs to the fluorinated hydrocarbon group of volatile anesthetic gases

Health volunteer

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age

You may not qualify if:

• previous history of significant liver disease (e.g. Cirrhosis) or lab values outside normal range \*;
• cardiac or respiratory illnesses (e.g. ischemic heart disease, asthma, chronic obstructive pulmonary disease/smoking hx \>10 pack per year history);
• any renal impairment or lab values outside normal \*;
• previous possible allergy to methoxyflurane by the patient or a
• drug interactions: concurrent use of any potential nephrotoxic drugs relative; (aminoglycosidese.g. gentamicin), colistin, polymyxin B, amphotericin B, and tetracyclines);
• personal or family history of malignant hyperthermia;
• pregnancy or breastfeeding;
• and history of use of methoxyflurane in the last 3 months.
• normal laboratory values will be determined based on The Ottawa Hospital's available reference ranges.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Mayday Fund: collaborator

Study Sites (1)

Dr Michael A Austin

Ottawa, Ontario, K1H 1E2, Canada

Location

MeSH Terms

Interventions

Methoxyflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Design

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

Model Details: This is a phase other study. This is a phase other, Health Canada regulated, non-clinical occupational exposure laboratory study, where 30 healthy human participants will inhale methoxyflurane following a protocol and during which occupational exposure of methoxyflurane will be measured via strategically positioned samplers (active and passive) according to a pre-set protocol, including single and multiple consecutive events.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 13, 2023
• Study Start: September 1, 2023
• Primary Completion: July 20, 2024
• Study Completion: September 30, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)