Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392087
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-19
Brief Title:
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane Study
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Prehospital Analgesia in Adults Using Inhaled PAIN Methoxyflurane Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Its important to treat pain well because it can make people sick and slow down healing But often pain isnt 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 Its a gas you breathe in through a special inhaler Its 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 Its 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
Paramedics use different drugs to manage pain but some are hard to give and need special training and equipment Methoxyflurane is a new option Its a gas you breathe in through a special inhaler Its 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 Its 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
Detailed Description:
The aim of this multi-centred study is to evaluate the prehospital use of methoxyflurane in patients 18 years of age presenting with moderate to severe pain verbal numeric pain rating scale NPRS 4 secondary to trauma which is defined as a physical injury of sudden onset and severity which requires immediate medical attention as compared to other current therapies available to paramedics NSAIDS and Opioids
This will be a prehospital prospective stepped-wedge open-label non-blinded cluster randomized trial enrolling patients with trauma related moderate to severe pain numerical pain rating scale 4 It will be composed of three phases involving a total of seven Ontario paramedic services Our 24-month study will consist of the three following phases 1 a 6-month setup and training period followed by phase 2 the stepped-wedge trial 8-months and phase 3 a 9-month period for data analysis and knowledge dissemination
The verbal numeric pain rating scale NPRS is a subjective measure in which individuals rate their pain on an eleven-point numeric scale The scale is comprised of values ranging from 0 no pain at all to 10 worst imaginable pain After ethics approvals have been secured for all sites and after the initial 4-week observation period where paramedics will provide standard care one paramedic service will be randomized using a number generator which the study team will be blinded to the intervention condition Methoxyflurane Additional paramedic services will subsequently be randomized and notified one by one at 4 week intervals until all seven paramedic services have been randomized to the intervention arm Data will be collected for all eligible patients in each paramedic service for a total duration of 8 months The study will be conducted in seven paramedic services in Eastern Ontario and will enrol patients who have been treated by paramedics trained and authorized in the use and administration of methoxyflurane
Eastern Ontario comprises 35 300 km2 and has a total regional population of 176 million There are eight base hospitals in Ontario that provide medical direction leadership and advice in the provision of prehospital emergency care The Regional Paramedic Program for Eastern Ontario RPPEO is the base hospital which provides oversight to the seven included paramedic services These paramedic services are comprised of 944 paramedics 738 of which are Primary Care Paramedics and 256 who are Advanced Care Paramedics In summary this study will comprise seven land paramedic services operating in a catchment area of 10 rural counties and 4 cities with 18 acute care hospitals and 1 university hospital
This will be a prehospital prospective stepped-wedge open-label non-blinded cluster randomized trial enrolling patients with trauma related moderate to severe pain numerical pain rating scale 4 It will be composed of three phases involving a total of seven Ontario paramedic services Our 24-month study will consist of the three following phases 1 a 6-month setup and training period followed by phase 2 the stepped-wedge trial 8-months and phase 3 a 9-month period for data analysis and knowledge dissemination
The verbal numeric pain rating scale NPRS is a subjective measure in which individuals rate their pain on an eleven-point numeric scale The scale is comprised of values ranging from 0 no pain at all to 10 worst imaginable pain After ethics approvals have been secured for all sites and after the initial 4-week observation period where paramedics will provide standard care one paramedic service will be randomized using a number generator which the study team will be blinded to the intervention condition Methoxyflurane Additional paramedic services will subsequently be randomized and notified one by one at 4 week intervals until all seven paramedic services have been randomized to the intervention arm Data will be collected for all eligible patients in each paramedic service for a total duration of 8 months The study will be conducted in seven paramedic services in Eastern Ontario and will enrol patients who have been treated by paramedics trained and authorized in the use and administration of methoxyflurane
Eastern Ontario comprises 35 300 km2 and has a total regional population of 176 million There are eight base hospitals in Ontario that provide medical direction leadership and advice in the provision of prehospital emergency care The Regional Paramedic Program for Eastern Ontario RPPEO is the base hospital which provides oversight to the seven included paramedic services These paramedic services are comprised of 944 paramedics 738 of which are Primary Care Paramedics and 256 who are Advanced Care Paramedics In summary this study will comprise seven land paramedic services operating in a catchment area of 10 rural counties and 4 cities with 18 acute care hospitals and 1 university hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None