Conscious Sedation Clinical Trial
Official title:
Current Procedural Sedation Practices for Adults and Children in a Canadian Community Emergency Department
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.
Procedural sedation is a common practice in the Emergency Department setting. The purpose of
procedural sedation is to provide adequate pain relief to patients undergoing an emergent
procedure. As a result, the time to the patient's symptom relief, the degree of side effects
and the duration of action of the medication are all critical to selecting an appropriate
sedative and/or analgesic.
The community hospital setting may present unique challenges to successfully administering
procedural sedation techniques. Funding and resource allocation can limit patient access to
timely sedation/analgesia. This can be compounded by prolonged stays in the Emergency
Department for recovery and/or complications.
The current recommendations for 'Procedural Sedation and Analgesia in the Emergency
Department' outlines recommended medications and policies for adults and children undergoing
procedural sedation1,2. While a number of cohort and retrospective analyses have been done in
a variety of research settings, the role for oral or intranasal anesthesia has not been
adequately explored in ED settings. The initial phase of this research proposal will identify
current local practices through chart review analysis collected over the last year.
Subsequent research questions might include a comparative analysis of the current procedural
sedation techniques compared to medications administered orally or by inhalation. This may
have considerable future benefit to patient satisfaction and clinical outcomes, as well as
resource and operational outcomes in the Emergency Department.
Hypothesis
To identify interventions requiring procedural sedation and the medication commonly used in a
Canadian community emergency department (ED). Using standardized medical record review
methods, primary clinical patient indicators, safety outcomes and secondary ED operational
outcomes will be reviewed.3
Study Design
This retrospective chart review will be obtained from data of patients who have registered in
the Welland County General Hospital (WHS) from the dates of January 2017 -December 2018. This
timeframe should capture a sample size of ~300 patients.
Patients will be included in our study if they have received conscious sedation for a
diagnostic or therapeutic procedure in the emergency department. They will be identified
through review of billing records for anesthesia codes. Medical records, specifically
physician procedural sedation records and nursing documentation, will be our main resources
for data extraction. The investigators will describe and quantify the procedures requiring
conscious sedation and identify the medication (and route) used, using a standardized data
abstraction tool to be created from international ED PSA guidelines.1,2 Primary outcome
measures will include ED PSA indications, pre-procedural assessments (medical comorbidities,
difficult airway predictors, other safety factors), medications used, sedation failures/use
of rescue medications, procedural successes or failures, post-PSA assessments, PSA recovery
and patient disposition. Further stratification by age and other demographic features will
help us better understand trends between the adult and pediatric population.
Patients requiring anaesthesia for the purpose of intubation and ventilator support will be
excluded from this study.
Our secondary outcomes involve resource utilization and complications. Duration of procedure
and time to discharge will be measured. Data on adverse outcomes and unplanned admission
rates will also be collected. Adverse outcomes of interest will be vomiting, medication for
blood pressure support, dysrhythmias, unanticipated intubation, laryngospasm, pulse oximetry
less than 90%, apnea requiring bag-valve-mask ventilation and death.
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