Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
Primary Purpose
Pain, Acute, Trauma
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Methoxyflurane
Sponsored by
About this trial
This is an interventional other trial for Pain, Acute focused on measuring prehospital, paramedic, ambulance, methoxyflurane, Penthrox, Penthrane
Eligibility Criteria
Inclusion Criteria:
- >=18 years of age
- Acute pain from traumatic injury
- numeric pain score >=4
Exclusion Criteria:
- Allergy or sensitivity to methoxyflurane
- History or family history of malignant hyperthermia
- Pregnant or breast-feeding patients
- Known renal impairment
- Known liver disease
- Methoxyflurane use within previous 3 months
Sites / Locations
- Dr Michael A Austin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention Arm
Arm Description
Methoxyflurane will be introduced and data will be captured to inform future multicentred step wedge design study. (This study is a feasibility study)
Outcomes
Primary Outcome Measures
Time to ethics approval for single site
Target: ,<= 3 months (90 days) from ethics submission
Time to readiness to initiate the clinical trial
Target, <= 3 months (90 days) from ethics approval
Evaluation of outcome data collected
Target: 100% of data captured in >90% cases
Study protocol compliance by paramedics
Target, >= 80%
Secondary Outcome Measures
Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes
Degree of change
Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)
If other medication are used to control pain
Transport time
Defined by departure from scene to arrival at hospital
Time to first administration of methoxyflurane
Time from first patient contact to first inhalation of methoxyflurane
Vital signs and level of consciousness
Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))
Adverse events post administration of methoxyflurane:
Example: any advanced airway interventions, oxygen requirement (oxygen saturations <94%), drop in blood pressure by 40% and/or <90 systolic, complaints of nausea or vomiting, malignant hyperthermia reaction).
Full Information
NCT ID
NCT04287803
First Posted
December 2, 2019
Last Updated
February 27, 2023
Sponsor
Ottawa Hospital Research Institute
Collaborators
University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT04287803
Brief Title
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
Official Title
Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Methoxyflurane is a safe, easy and effective choice in prehospital management of pain. The impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital Canadian National Guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.
Detailed Description
This will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. The feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. A waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. Patient >= 18 years of age with traumatic pain with a verbal score >= to 4 will be enrolled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Trauma
Keywords
prehospital, paramedic, ambulance, methoxyflurane, Penthrox, Penthrane
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention Arm
Arm Type
Experimental
Arm Description
Methoxyflurane will be introduced and data will be captured to inform future multicentred step wedge design study. (This study is a feasibility study)
Intervention Type
Drug
Intervention Name(s)
Methoxyflurane
Other Intervention Name(s)
Penthrox, Penthrane
Intervention Description
Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4
Primary Outcome Measure Information:
Title
Time to ethics approval for single site
Description
Target: ,<= 3 months (90 days) from ethics submission
Time Frame
from ethics submission up to 90 days
Title
Time to readiness to initiate the clinical trial
Description
Target, <= 3 months (90 days) from ethics approval
Time Frame
From ethics approval up to 90 days
Title
Evaluation of outcome data collected
Description
Target: 100% of data captured in >90% cases
Time Frame
For length of study, up to 100 patients
Title
Study protocol compliance by paramedics
Description
Target, >= 80%
Time Frame
For length of study, up to 100 patients
Secondary Outcome Measure Information:
Title
Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes
Description
Degree of change
Time Frame
For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department
Title
Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)
Description
If other medication are used to control pain
Time Frame
For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department
Title
Transport time
Description
Defined by departure from scene to arrival at hospital
Time Frame
For length of study, up to 100 patients, specifically departure scene to arrival at hospital
Title
Time to first administration of methoxyflurane
Description
Time from first patient contact to first inhalation of methoxyflurane
Time Frame
For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane
Title
Vital signs and level of consciousness
Description
Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))
Time Frame
From patient contact to transfer of care
Title
Adverse events post administration of methoxyflurane:
Description
Example: any advanced airway interventions, oxygen requirement (oxygen saturations <94%), drop in blood pressure by 40% and/or <90 systolic, complaints of nausea or vomiting, malignant hyperthermia reaction).
Time Frame
For length of study, up to 100 patients. Specifically from patient contact to transfer of care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>=18 years of age
Acute pain from traumatic injury
numeric pain score >=4
Exclusion Criteria:
Allergy or sensitivity to methoxyflurane
History or family history of malignant hyperthermia
Pregnant or breast-feeding patients
Known renal impairment
Known liver disease
Methoxyflurane use within previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Austin, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Michael A Austin
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data for primary and secondary outcome maybe available to share.
Learn more about this trial
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
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