Reduction of Anterior Shoulder Dislocation Facilitated by Inhaled Low Dose Methoxyflurane

NCT03853954 | Completed

• 1 other identifier: CapitalDHACCanada
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. The hypothesis includes that time to reduction and time spent in the emergency department will be reduced.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to a maximum of 24 hours from emergency department registration

Secondary Outcomes (3)

• Time to discharge from ED

  Up to a maximum of 24 hours from emergency department registration

• Provider satisfaction with the process

  Completed within 30 minutes of intervention

• Treatment-related adverse events

  Up to a maximum of 24 hours from emergency department registration

Study Arms (1)

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

Device: Methoxyflurane

Interventions

Methoxyflurane DEVICE

Methoxyflurane (Penthrox) inhaler, 3mL inhalation vapour, liquid

Also known as: Penthrox

Methoxyflurane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

NSHA

Halifax, Nova Scotia, B3H3A7, Canada

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Samuel G Campbell, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 26, 2019
• Study Start: June 1, 2019
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)