RecruitingPhase 4ACTRN12607000548437

Patient controlled sedation with propofol for emergency department procedures

Total propofol dose in physician versus patient controlled sedation for emergency department procedures


Sponsor

Royal Brisbane and Women's Hospital

Enrollment

160 participants

Start Date

Dec 1, 2007

Study Type

Interventional

Conditions

Summary

Procedural sedation is frequently used in Emergency Departments (ED) for orthopaedic reductions, cardioversions and other painful but brief procedures. Various pharmacologic agents have been used, including nitrous oxide, ketamine, propofol and combinations of benzodiazepine and opioid. Propofol, a potent, short-acting sedative agent, has gained widespread popularity and has been shown to be safe for procedural sedation in the ED. The advantages of propofol include rapid onset, short duration of action, antiemetic effect and high degree of patient satisfaction. Potential disadvantages include deep sedation, apnoea and hypotension. Patient controlled sedation (PCS) has been investigated for more than 20 years, primarily for minor procedures in the operating theatre, such as colonoscopy and dental extractions. The potential advantage of the PCS technique is that the patient is able to match their sedation requirement with the noxious stimuli and titrate themselves to an appropriate level of sedation without the risk of over-sedation. A second potential advantage of PCS is the psychological benefit it confers on its user with a sense of control over a stressful and painful procedure. Little data has been published on the use of PCS in the ED setting. The objective of this study is to investigate the efficacy of using propofol in a standard patient-controlled infusion pump for procedural sedation in the ED.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients in the Emergency Department can safely and effectively control their own sedation (pain relief and relaxation) using a self-press button pump that delivers a sedative drug called propofol. This is called Patient Controlled Sedation. The idea is that patients can match the amount of sedation to how painful or uncomfortable a procedure feels, which could reduce the risk of getting too much sedation. This is commonly used for short painful procedures like setting broken bones. You may be eligible if: - You are 16 years of age or older - You need a short procedure in the Emergency Department that requires sedation You may NOT be eligible if: - You have limited English language understanding - You are physically unable to press the button on the pump - You have a known allergy to propofol - You are expected to have a difficult airway - You are pregnant Talk to your doctor about whether this trial might be right for you.

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

A prospective, unblinded, randomised controlled trial will be conducted at a metropolitan tertiary-referral teaching hospital ED with an annual census of 70,000. The use of propofol for procedural sed

A prospective, unblinded, randomised controlled trial will be conducted at a metropolitan tertiary-referral teaching hospital ED with an annual census of 70,000. The use of propofol for procedural sedation by emergency physicians or advanced trainees is an established practice in our ED. After administration of analgesia and confirmation of the diagnosis, eligible patients will be invited to participate in the study. Consented participants will then be randomised to the emergency physician-administered (EPA) propofol sedation group or the patient-controlled propofol sedation (PCS) group. The EPA group will receive propofol sedation at the discretion of the treating physician. The PCS group will undergo sedation using a patient-controlled infusion pump containing propofol. An initial bolus of 0.5-0.75mg/kg will be delivered, followed by self-administered increments of 20 mg with a lockout period of 1 minute.


Locations(1)

Australia

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ACTRN12607000548437