RecruitingACTRN12622000095763

ProSed Australasia: A database of procedural sedation practices and outcomes in Australasian Emergency Departments

ProSed Australasia: A database of procedural sedation performed in Australasian Emergency Departments for analysis of the interaction between medications used, doses used, adverse events, procedure success rates, and outcomes


Sponsor

Northern Sydney Local Health District

Enrollment

100,000 participants

Start Date

Dec 10, 2021

Study Type

Observational

Conditions

Summary

Procedural sedation involves the administration of sedative medications to facilitate a painful or intolerable procedure. It is commonly performed in emergency departments for reduction of a range of orthopaedic injuries, to facilitate cardioversion for tachyarrhythmias, amongst other uses. The usual practice involves one clinician performing sedation, another clinician performing a procedure, and a nurse assisting with medications, monitoring and documentation. It is generally performed in a resuscitation bay to be prepared for any complications that may arise. Procedural sedation is commonly performed in Australasian emergency departments however the evidence base for the practice of it is not as robust as many other areas. Drugs used for procedural sedation have changed over time with introduction of newer agents, however there remains a lack of evidence as to best practices. As such the administration of procedural sedation varies widely with significant variation within departments and even wider variation internationally. We are establishing a database of all procedural sedation performed at our hospital with a view to expanding this database state-wide and eventually throughout Australasia. This large dataset will allow us to analyse the sedation performed and draw associations between the patients involved, the medications used, adverse events, and procedure success rates.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

Procedural sedation is when sedative medications are given to help a patient tolerate a painful or distressing medical procedure — for example, setting a broken bone or resetting a dislocated shoulder in the emergency department. It is a common and generally safe practice, but the specifics of how it is performed vary widely between hospitals and even between individual doctors, and the evidence base guiding best practice is surprisingly limited. The ProSed Australasia registry is building a comprehensive database of all procedural sedation performed at participating emergency departments across Australia and New Zealand. No extra procedures or medications are involved — data is simply collected from each sedation event, including the medications used, patient characteristics, any adverse events, and whether the procedure was successful. All patients undergoing procedural sedation at a participating site are eligible, with no exclusions. The large dataset created by this registry will allow researchers to identify patterns, compare drug choices, and draw meaningful conclusions about what leads to the safest and most successful outcomes. Over time, this could result in clearer, evidence-based guidelines for one of the most common interventions in emergency medicine.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Our registry will include all patients undergoing procedural sedation in the emergency department at the involved sites. The observation will continue until the end of the sedation once the patient is

Our registry will include all patients undergoing procedural sedation in the emergency department at the involved sites. The observation will continue until the end of the sedation once the patient is waking up, less than an hour. Information will be recorded regarding the indication for sedation, where it was performed, who performed it, patient weight, American Society of Anesthesiologists (ASA) grade, medications given for the procedure, adverse events, management required, deepest level of sedation achieved, and disposition. Data will be entered into a form by the clinician performing the procedure, to happen as soon as possible after the procedure takes place. Data will be collected for 20 years.


Locations(1)

Royal North Shore Hospital - St Leonards

NSW, Australia

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ACTRN12622000095763


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