Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane
Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane - a Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Samuel G Campbell, MD, CCFP(EM)
- Phone Number: 902-473-2020
- Email: samuel.campbell@nshealth.ca
Study Contact Backup
- Name: Hana M Wiemer, MD, CCFP(EM)
- Phone Number: 902-473-2020
- Email: hana.wiemer@dal.ca
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H3A7
- NSHA
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Anterior dislocation not complicated by fracture (pre-reduction x-rays will be done at the discretion of the emergency physician)
- No neurological or vascular injury
- Patients greater than or equal to 18 years of age
- Patients able to understand the nature of the study and give written informed consent
- Patient is able to follow all study requirements and procedures and complete all questionnaires
Exclusion Criteria:
- Previous shoulder surgery on the affected side
- Associated fracture or secondary significant injury
- Previous in-hospital reduction attempt for the current dislocation
- Open wound or infection in the vicinity of the joint
- Uncorrectable altered level of consciousness, to be defined by the attending clinician as a Glasgow-Coma Scale of less than 15, due to any cause, including head injury, drugs, or alcohol
- History of clinically significant renal impairment
- History of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics
- Hypersensitivity to methoxyflurane or other halogenated anesthetics
- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
- Clinically evident hemodynamic instability
- Clinically evident respiratory impairment
- Has received methoxyflurane within the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Methoxyflurane
Dosage form: inhalation Dosage: 3 mL methoxyflurane per inhaler, to be self-administered Frequency: maximum one inhaler (3 mL) per patient Duration: <15 minutes
|
Methoxyflurane (Penthrox) inhaler, 3mL inhalation vapour, liquid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of first reduction attempt success
Time Frame: Minutes from the beginning of procedure (maximum 15 minutes)
|
'First attempt' will be defined as 'That before a decision is made to try a different method of reduction' - i.e. a pause during the attempt to allow further muscle relaxation and analgesia will not imply failure of the first attempt however if no success at the 15-minute mark, the procedure will be aborted and standard PSA will be conducted for further reduction attempts.
|
Minutes from the beginning of procedure (maximum 15 minutes)
|
|
Time of arrival to beginning of first reduction attempt
Time Frame: Up to a maximum of 24 hours from emergency department registration
|
Documented triage time to time of methoxyflurane administration.
|
Up to a maximum of 24 hours from emergency department registration
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to discharge from ED
Time Frame: Up to a maximum of 24 hours from emergency department registration
|
Documented triage time to time patient is ready for discharge
|
Up to a maximum of 24 hours from emergency department registration
|
|
Provider satisfaction with the process
Time Frame: Completed within 30 minutes of intervention
|
5-Point Likert scale of provider satisfaction with process: 1-poor, 2-fair, 3-good, 4-very good, 5-excellent
|
Completed within 30 minutes of intervention
|
|
Treatment-related adverse events
Time Frame: Up to a maximum of 24 hours from emergency department registration
|
Incidence of the following treatment-related adverse effects in the study population: hypotension (SBP <100 mmHg OR <85 mmHg if baseline SBP <100 mmHg), vomiting, somnolence, amnesia, dizziness, headache, cough, other (document), none
|
Up to a maximum of 24 hours from emergency department registration
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Samuel G Campbell, MD, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CapitalDHACCanada
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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