Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-28 @ 8:54 PM
Study NCT ID:
NCT04287803
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2019-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008733', 'term': 'Methoxyflurane'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Feasibility study to inform the multicentred prehospital prospective observational step wedge design trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to ethics approval for single site', 'timeFrame': 'from ethics submission up to 90 days', 'description': 'Target: ,\\<= 3 months (90 days) from ethics submission'}, {'measure': 'Time to readiness to initiate the clinical trial', 'timeFrame': 'From ethics approval up to 90 days', 'description': 'Target, \\<= 3 months (90 days) from ethics approval'}, {'measure': 'Evaluation of outcome data collected', 'timeFrame': 'For length of study, up to 100 patients', 'description': 'Target: 100% of data captured in \\>90% cases'}, {'measure': 'Study protocol compliance by paramedics', 'timeFrame': 'For length of study, up to 100 patients', 'description': 'Target, \\>= 80%'}], 'secondaryOutcomes': [{'measure': 'Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes', 'timeFrame': 'For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department', 'description': 'Degree of change'}, {'measure': 'Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)', 'timeFrame': 'For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department', 'description': 'If other medication are used to control pain'}, {'measure': 'Transport time', 'timeFrame': 'For length of study, up to 100 patients, specifically departure scene to arrival at hospital', 'description': 'Defined by departure from scene to arrival at hospital'}, {'measure': 'Time to first administration of methoxyflurane', 'timeFrame': 'For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane', 'description': 'Time from first patient contact to first inhalation of methoxyflurane'}, {'measure': 'Vital signs and level of consciousness', 'timeFrame': 'From patient contact to transfer of care', 'description': 'Vital signs including (Heart rate, Blood pressure, Respiratory rate, Oxygen saturation, Temperature, Glasgow Coma Scale (GCS))'}, {'measure': 'Adverse events post administration of methoxyflurane:', 'timeFrame': 'For length of study, up to 100 patients. Specifically from patient contact to transfer of care', '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehospital', 'paramedic', 'ambulance', 'methoxyflurane', 'Penthrox', 'Penthrane'], 'conditions': ['Pain, Acute', 'Trauma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>=18 years of age\n* Acute pain from traumatic injury\n* numeric pain score \\>=4\n\nExclusion Criteria:\n\n* Allergy or sensitivity to methoxyflurane\n* History or family history of malignant hyperthermia\n* Pregnant or breast-feeding patients\n* Known renal impairment\n* Known liver disease\n* Methoxyflurane use within previous 3 months'}, 'identificationModule': {'nctId': 'NCT04287803', 'briefTitle': 'Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study', 'orgStudyIdInfo': {'id': '20191107100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention 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)', 'interventionNames': ['Drug: Methoxyflurane']}], 'interventions': [{'name': 'Methoxyflurane', 'type': 'DRUG', 'otherNames': ['Penthrox', 'Penthrane'], 'description': 'Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores \\>=4', 'armGroupLabels': ['intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 1E2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr Michael A Austin', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Michael A Austin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified data for primary and secondary outcome maybe available to share.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ottawa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}