Pain, Acute, Trauma
Conditions
Keywords
prehospital, paramedic, ambulance, methoxyflurane, Penthrox, Penthrane
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.
Interventions
DRUGMethoxyflurane
Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores \>=4
Sponsors
University of Ottawa
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to ethics approval for single site | from ethics submission up to 90 days | Target: ,\<= 3 months (90 days) from ethics submission |
| Time to readiness to initiate the clinical trial | From ethics approval up to 90 days | Target, \<= 3 months (90 days) from ethics approval |
| Evaluation of outcome data collected | For length of study, up to 100 patients | Target: 100% of data captured in \>90% cases |
| Study protocol compliance by paramedics | For length of study, up to 100 patients | Target, \>= 80% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs and level of consciousness | From patient contact to transfer of care | Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS)) |
| Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes | For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department | Degree of change |
| Adverse events post administration of methoxyflurane: | For length of study, up to 100 patients. Specifically from patient contact to transfer of care | 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). |
| Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care) | For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department | If other medication are used to control pain |
| Transport time | For length of study, up to 100 patients, specifically departure scene to arrival at hospital | Defined by departure from scene to arrival at hospital |
| Time to first administration of methoxyflurane | For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane | Time from first patient contact to first inhalation of methoxyflurane |
Countries
Canada
Outcome results
None listed