Shoulder DislocationNCT03853954
Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane
A study testing Methoxyflurane in people with Shoulder Dislocation, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
This pilot study will test the feasibility of doing a definitive study to ascertain whether reduction of shoulder dislocation can be safely and effectively facilitated by a patient controlled inhalational analgesic, negating the need for potentially dangerous PSA and the use of intravenous therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Methoxyflurane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane - a Pilot Study
This pilot study will test the feasibility of doing a definitive study to ascertain whether reduction of shoulder dislocation can be safely and effectively facilitated by a patient controlled inhalational analgesic, negating the need for potentially dangerous PSA and the use of intravenous therapy. The hypothesis includes that time to reduction and time spent in the emergency department will be reduced.
Read the detailed description
Anterior shoulder dislocation, in which the head of the humerus (cup) comes out of its position in the glenoid fossa (saucer), to lie anterior and below its proper position, is a common emergency department presentation. Between April 1, 2011 and March 31, 2018, 1654 patients presented to emergency departments in Emergency Departments of the Central Zone of the Nova Scotia Health Authority (Average 236/year). The treatment of dislocated shoulder involves reduction to a normal anatomical position as soon as possible, to manage pain and disability and to minimize the chance of poor long term outcome. Numerous methods exist to effect reduction, most of which are conducted under procedural sedation and analgesia (PSA) that allows the shoulder muscles to relax so that they do not hold the humeral head in a dislocated position. PSA involves the administration of intravenous sedatives and narcotic analgesics. Not only do the medications carry the risk of respiratory depression and hypotension, but their duration of action results in longer emergency department stays and the use of intravenous lines, is invasive and adds patient discomfort and expense to the procedure. An additional risk of PSA in this specific population is that reduction of the dislocation to its normal position, immediately removes the painful stimulus that antagonizes the respiratory depression of the sedative and analgesic agents. This often results in unopposed respiratory depression which might be unrecognized as the 'crisis' appears to be over with the restoration of the shoulder joint. Furthermore, PSA requires specifically trained staff and space; and time taken to arrange PSA prolongs the time during which the humerus is out of position. It has been reported that from the time of arrival in the emergency department with an anterior shoulder dislocation, every 10 min delay in reduction attempt increased the odds of a failed reduction attempt by 19%. In the Charles V. Keating Emergency and Trauma Centre in Halifax, Nova Scotia, PSA is conducted by specially trained advanced care paramedics using standard preparation, monitoring and recovery protocols. In an effort to painlessly reduce shoulder dislocations without PSA, the Cunningham technique has been described, which involves massaging the shoulder muscles in an attempt to get them to relax sufficiently to allow reduction. Although this method does work, and has been associated with decreased need for PSA, it is associated with an increase in the rate of unsuccessful first reduction attempts. After unsuccessful attempts using the Cunningham technique, the fallback is generally to then provide PSA, increasing the time to reduction. Inhaled low-dose methoxyflurane has been used for several decades in Australia as an emergency analgesic for short-term use. Administered via a portable, disposable, single-use hand-held inhaler device administered by the patient for pain relief, it offers a safe and effective non-opioid alternative to morphine. Inhaled methoxyflurane has been shown to be safe, effective, and simple to administer in obstetric patients during childbirth, as well as for patients with bone fractures and joint dislocations, and for dressing changes on burn patients. In 2018, PenthroxTM (methoxyflurane) received marketing authorization from Health Canada for adult patients requiring short-term relief from moderate to severe acute pain associated with trauma or interventional medical procedures. Low dose methoxyflurane adds to the armamentarium of Canadian emergency care providers as an option that is relatively inexpensive, safe and very easy to administer rapidly. As most failures of the Cunningham anterior shoulder reduction method are due to patient discomfort, the investigators hypothesize that inhaled low dose methoxyflurane has the potential to increase first attempt success rates using this method while decreasing the time from arrival to reduction, the need for intravenous therapy or the use of potentially dangerous medications. The Penthrox inhalers will be supplied by Purdue and will be stored in the emergency department in a locked cabinet in a locked box with limited access. It is a self controlled inhaled medication controlled by each inhalation. Each breath a patient takes releases a fraction of the single dose contained in the inhaler.
- Conditions
- Shoulder Dislocation
- Being tested
- Methoxyflurane
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDevice
Also called Penthrox
Methoxyflurane (Penthrox) inhaler, 3mL inhalation vapour, liquid
| Study group | Role | What they receive |
|---|---|---|
| Methoxyflurane | Experimental | Dosage form: inhalation Dosage: 3 mL methoxyflurane per inhaler, to be self-administered Frequency: maximum one inhaler (3 mL) per patient Duration: <15 minutes Receives: Device: Methoxyflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first reduction attempt success
'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.
Measured: Minutes from the beginning of procedure (maximum 15 minutes)
Time of arrival to beginning of first reduction attempt
Documented triage time to time of methoxyflurane administration.
Measured: Up to a maximum of 24 hours from emergency department registration
Secondary outcomes (3)
Time to discharge from ED
Documented triage time to time patient is ready for discharge
Measured: Up to a maximum of 24 hours from emergency department registration
Provider satisfaction with the process
5-Point Likert scale of provider satisfaction with process: 1-poor, 2-fair, 3-good, 4-very good, 5-excellent
Measured: Completed within 30 minutes of intervention
Treatment-related adverse events
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
Measured: Up to a maximum of 24 hours from emergency department registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Jun 2019
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective open-label pilot study will examine the use of inhaled low dose methoxyflurane to facilitate shoulder reduction in a convenience sample of patients arriving with anterior shoulder dislocations. This study will test the feasibility of studying the addition of this analgesic agent to a reduction technique that classically eschews procedural sedation in order to increase successful reduction rates. Consenting eligible patients will be offered a first attempt at reduction using the method described by Cunningham, supported by self-administered low-dose methoxyflurane analgesia as instructed by the advanced/critical care paramedic. For unsuccessful first attempts, patients will then undergo the current standard of care for shoulder dislocations, which is reduction of the shoulder joint while under procedural sedation and analgesia.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel G Campbell, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853954
- Sponsor's protocol ID
- CapitalDHACCanada
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane - a Pilot Study
- ClinicalTrials.gov ID
- NCT03853954
- Acronym / sponsor ID
- CapitalDHACCanada
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will test the feasibility of doing a definitive study to ascertain whether reduction of shoulder dislocation can be safely and effectively facilitated by a patient controlled inhalational analgesic, negating the need for potentially dangerous PSA and the use of intravenous therapy. The hypothesis includes that time to reduction and time spent in the emergency department will be reduced.
Detailed description
Anterior shoulder dislocation, in which the head of the humerus (cup) comes out of its position in the glenoid fossa (saucer), to lie anterior and below its proper position, is a common emergency department presentation. Between April 1, 2011 and March 31, 2018, 1654 patients presented to emergency departments in Emergency Departments of the Central Zone of the Nova Scotia Health Authority (Average 236/year). The treatment of dislocated shoulder involves reduction to a normal anatomical position as soon as possible, to manage pain and disability and to minimize the chance of poor long term outcome. Numerous methods exist to effect reduction, most of which are conducted under procedural sedation and analgesia (PSA) that allows the shoulder muscles to relax so that they do not hold the humeral head in a dislocated position. PSA involves the administration of intravenous sedatives and narcotic analgesics. Not only do the medications carry the risk of respiratory depression and hypotension, but their duration of action results in longer emergency department stays and the use of intravenous lines, is invasive and adds patient discomfort and expense to the procedure. An additional risk of PSA in this specific population is that reduction of the dislocation to its normal position, immediately removes the painful stimulus that antagonizes the respiratory depression of the sedative and analgesic agents. This often results in unopposed respiratory depression which might be unrecognized as the 'crisis' appears to be over with the restoration of the shoulder joint. Furthermore, PSA requires specifically trained staff and space; and time taken to arrange PSA prolongs the time during which the humerus is out of position. It has been reported that from the time of arrival in the emergency department with an anterior shoulder dislocation, every 10 min delay in reduction attempt increased the odds of a failed reduction attempt by 19%. In the Charles V. Keating Emergency and Trauma Centre in Halifax, Nova Scotia, PSA is conducted by specially trained advanced care paramedics using standard preparation, monitoring and recovery protocols. In an effort to painlessly reduce shoulder dislocations without PSA, the Cunningham technique has been described, which involves massaging the shoulder muscles in an attempt to get them to relax sufficiently to allow reduction. Although this method does work, and has been associated with decreased need for PSA, it is associated with an increase in the rate of unsuccessful first reduction attempts. After unsuccessful attempts using the Cunningham technique, the fallback is generally to then provide PSA, increasing the time to reduction. Inhaled low-dose methoxyflurane has been used for several decades in Australia as an emergency analgesic for short-term use. Administered via a portable, disposable, single-use hand-held inhaler device administered by the patient for pain relief, it offers a safe and effective non-opioid alternative to morphine. Inhaled methoxyflurane has been shown to be safe, effective, and simple to administer in obstetric patients during childbirth, as well as for patients with bone fractures and joint dislocations, and for dressing changes on burn patients. In 2018, PenthroxTM (methoxyflurane) received marketing authorization from Health Canada for adult patients requiring short-term relief from moderate to severe acute pain associated with trauma or interventional medical procedures. Low dose methoxyflurane adds to the armamentarium of Canadian emergency care providers as an option that is relatively inexpensive, safe and very easy to administer rapidly. As most failures of the Cunningham anterior shoulder reduction method are due to patient discomfort, the investigators hypothesize that inhaled low dose methoxyflurane has the potential to increase first attempt success rates using this method while decreasing the time from arrival to reduction, the need for intravenous therapy or the use of potentially dangerous medications. The Penthrox inhalers will be supplied by Purdue and will be stored in the emergency department in a locked cabinet in a locked box with limited access. It is a self controlled inhaled medication controlled by each inhalation. Each breath a patient takes releases a fraction of the single dose contained in the inhaler.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective open-label pilot study will examine the use of inhaled low dose methoxyflurane to facilitate shoulder reduction in a convenience sample of patients arriving with anterior shoulder dislocations. This study will test the feasibility of studying the addition of this analgesic agent to a reduction technique that classically eschews procedural sedation in order to increase successful reduction rates. Consenting eligible patients will be offered a first attempt at reduction using the method described by Cunningham, supported by self-administered low-dose methoxyflurane analgesia as instructed by the advanced/critical care paramedic. For unsuccessful first attempts, patients will then undergo the current standard of care for shoulder dislocations, which is reduction of the shoulder joint while under procedural sedation and analgesia.
| Arm | Type | Receives |
|---|---|---|
| Methoxyflurane | Experimental | Device: MethoxyfluraneDosage form: inhalation Dosage: 3 mL methoxyflurane per inhaler, to be self-administered Frequency: maximum one inhaler (3 mL) per patient Duration: <15 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethoxyfluraneAlso: PenthroxMethoxyflurane (Penthrox) inhaler, 3mL inhalation vapour, liquid | Device | Methoxyflurane |
Primary outcome
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.
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.
3 secondary outcomes
Time to discharge from ED
Time frame: Up to a maximum of 24 hours from emergency department registration
Provider satisfaction with the process
Time frame: Completed within 30 minutes of intervention
Treatment-related adverse events
Time frame: Up to a maximum of 24 hours from emergency department registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel G Campbell, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methoxyflurane in people with Shoulder Dislocation, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of first reduction attempt success (time frame: Minutes from the beginning of procedure (maximum 15 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.