A study protocol for a feasibility study: Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS)-a multi-centre feasibility study protocol.

This study will recruit in four emergency departments in Scotland, UK. Patients aged 18-65 years with anterior shoulder dislocation, weighing ≥ 50 kg and fasted ≥ 90 min, will be screened. Recruited patients will undergo emergency reduction of a dislocated shoulder facilitated by procedural sedation utilising TCI of propofol.The widespread adoption of TCI propofol by emergency departments will require evidence that it is safe, potentially effective, patient centred and a timely method of providing procedural sedation. The primary endpoint will be acceptability measured by patient satisfaction. The secondary endpoints will include incidence and severity of adverse events, number of shoulder reduction attempts, nursing opinion of patient experience, patient's reported pain score and time from commencement of TCI propofol sedation to desired sedation level.The study will be open for recruitment from April 2017 to December 2018. Discussion: If the study demonstrates patient acceptability with adequate recruitment, we will be in a position to determine the feasibility of progression to a randomised controlled clinical trial of TCI compared to bolus administration of propofol. Trial registration: ClinicalTrials.gov Identifier: NCT03442803. Registered retrospectively on 22 February 2018. PMID: 30820338 [PubMed]
Source: Pain Physician - Category: Anesthesiology Authors: Tags: Pilot Feasibility Stud Source Type: research