None listed
Conditions
Brief 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.
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 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-admin
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.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient requiring a procedural sedation as part of their treatment in the emergency department
Exclusion criteria
Inadequate English language comprehension, Physical inability to use the handset of a patient-controlled infusion pump, Known allergy or hypersensitivity to propofol, Anticipated airway difficulty, Pregnancy Pregnancy.
Outcome results
None listed