Current Procedural Sedation Practices in a Canadian Community Emergency Department
1 other identifier
observational
300
1 country
1
Brief Summary
To review current Emergency Department procedural sedation practices in the community hospital setting and the associated drugs used (class of anesthetic and mode of administration). The ultimate goal of this investigation is to determine the need for a new analgesic/anesthesia drug and to compare the outcomes of a new drug within the same community Emergency Department setting. In particular, this may present a future opportunity to evaluate Penthrox (methoxyflurane) as a viable alternative for procedural sedation and analgesia in Canadian Emergency Departments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
November 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 21, 2019
November 1, 2019
6 months
October 29, 2019
November 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Procedural Sedation
Total number of patients requiring conscious sedation
2 years
Medication Use
The number and type of medications used during procedure
2 years
Pre Procedural Assessment Findings
ASA score, 3-3-2 Abnormality, Pre-procedure Fast, Mallampatie Class, Neck Obesity, Facial Hair
2 years
Sedation Failures and Use of Rescue Medications
Number of occurrences where sedation is inadequate for treatment and number/type of rescue medication used to achieve adequate sedation
2 years
Time of Discharge
Time of patient discharge or transfer from Emergency Department
2 years
Secondary Outcomes (5)
Length of time spent in Emergency Department
2 years
Duration of Procedure and Time to discharge
2 years
Number of Adverse Outcomes
2 years
Rate of Hospital Admission
2 years
Time from Triage to initiation of procedural sedation
2 years
Study Arms (1)
Retrospective cohort
Patients that received procedural sedation in a community Emergency Department.
Interventions
Eligibility Criteria
Patients who have registered in the Welland County General Hospital Emergency Department (WHS) from the dates of January 2017 -December 2018 and require procedural sedation.
You may qualify if:
- patients who have registered in the Welland County General Hospital Emergency Department (WHS) from the dates of January 2017-December 2018.
- Patients who require procedural sedation in the Emergency Department
You may not qualify if:
- \- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amber Graystonelead
- Purdue Pharma LPcollaborator
Study Sites (1)
Niagara Health
St. Catharines, Ontario, L2S 0A9, Canada
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 21, 2019
Study Start
November 30, 2019
Primary Completion
June 1, 2020
Study Completion
October 1, 2020
Last Updated
November 21, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share