Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

Trauma Clinical Trial

Official title:

Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287803
• Other study ID #: 20191107100
• Status: Completed
• Phase: Phase 4
• Start date: April 12, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Trauma

Intervention

Drug:
• Methoxyflurane
Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4

Locations

Country	Name	City	State
Canada	Dr Michael A Austin	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ethics approval for single site	Target: ,<= 3 months (90 days) from ethics submission	from ethics submission up to 90 days
Primary	Time to readiness to initiate the clinical trial	Target, <= 3 months (90 days) from ethics approval	From ethics approval up to 90 days
Primary	Evaluation of outcome data collected	Target: 100% of data captured in >90% cases	For length of study, up to 100 patients
Primary	Study protocol compliance by paramedics	Target, >= 80%	For length of study, up to 100 patients
Secondary	Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes	Degree of change	For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department
Secondary	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	For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department
Secondary	Transport time	Defined by departure from scene to arrival at hospital	For length of study, up to 100 patients, specifically departure scene to arrival at hospital
Secondary	Time to first administration of methoxyflurane	Time from first patient contact to first inhalation of methoxyflurane	For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane
Secondary	Vital signs and level of consciousness	Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))	From patient contact to transfer of care
Secondary	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).	For length of study, up to 100 patients. Specifically from patient contact to transfer of care