None listed
Conditions
Brief summary
Despite pain being the primary reason most patients present to emergency departments (EDs), current methods of pain management in EDs are suboptimal. Patient controlled analgesia (PCA) involves the patient self-administering intravenous analgesia via a pre-set medication administration pump. Although PCAs have being rigorously evaluated and widely used in other clinical areas, they are not routinely used in EDs. This study will determine if PCAs are a feasible mode of analgesic delivery in the ED environment. A feasibility pilot randomised controlled trial (RCT) will be conducted in one private hospital ED to determine the feasibility of using PCAs in EDs. This research will add to a limited body of knowledge in the area of pain management in EDs and potentially enhance pain management in the ED through the use of PCAs. As this is a feasibility pilot RCT, we hypothesise that PCA will be a feasible mode of analgesic delivery in EDs, However a larger-scale, multi-site RCT will be needed to further investigate this topic. .
Interventions
Patient controlled analgesia (PCA) is a method widely used in surgical, obstetric, orthopaedic, and palliative care units to manage pain. PCA pumps are loaded with pre-filled syringes of an opioid analgesic, connected to a patient’s intravenous (IV) line, and analgesia is administered in set doses when the patient activates a button on the PCA. Lockout periods are pre-programmed to prevent patients from receiving unsafe doses of the medication. Research in the post-operative environment has identified several advantages of PCAs including increased patient autonomy, decreased nursing workload, decreased time to receive analgesia, and improved patient satisfaction (McNicol et al., 2015). Due to these benefits, PCAs are used extensively in other settings however their use in Emergency Departments (EDs) is minimal or non-existent. This feasibility pilot randomised controlled trial (RCT) will assess the feasibility of using PCAs in the ED. We will determine if PCAs are a feasible mode of analgaesic delivery in the ED environment by comparing the feasibility of using PCAs to conventional methods of analgaesic administration. Participants in the PCA group will receive a PCA device with an opioid analgaesic (fentanyl). The nurse will instruct the patient to press the PCA button when they are in pain to receive a 20 micrograms of intravenous fentanyl every five minutes. Staff education and resources will be provided prior to and during the study. This will include short in-service education sessions, step-by-step and troubleshooting guides, and contact numbers of resource staff who are familiar with PCA devices (eg Acute Pain Service team, Learning and Development Facilitators, surgical ward nurses, etc.). Participants in the control group will receive treatment as usual, which consists of a nurse titrating an IV opiate if prescribed by a doctor as needed. This phase of the study will occur for four hours or will cease when a disposition is complete. The feasibility of conducting a larger study will be assessed with the following criteria: feasibility of recruitment will be evidenced by at least 70% of eligible patients providing informed consent; acceptability of intervention, randomisation and procedures will be evidenced by at least 80% of recruited participants remaining in the study for the full study period (four hours or until discharge from ED); adherence to study protocol will be evidenced by at least 80% of the total pain scores recorded on the data collection sheet; and acceptability of treatment by nursing and medical staff will be assessed in a survey to staff who were involved in the care of a patient in this trial. References McNicol, E. D., Ferguson, M. C., & Hudcova, J. (2015). Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain. Cochrane Database of Systematic Reviews, 2015(6), 1–129.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients presenting with severe abdominal pain with a numeric rating scale (NRS) greater than or equal to five out of ten and are likely to require an intravenous opioid
Exclusion criteria
<18 years old, not able to read and understand English, abnormal vital sign parameters, contraindications to using a PCA device, written informed consent not provided, known allergy to opiates, reduced level of consciousness evidenced by a Glasgow Coma Score <15, inability to operate a PCA device (e.g. decreased hand dexterity or visually impaired), inability to understand information about the study (e.g. dementia, learning difficulties, drug or alcohol intoxication, or acute confusion), history of chronic pain, history of tolerance or an addiction to opioids, history of chronic exposure to opioids (e. g. IV drug user, regional pain syndrome, or oncology related pain management), history of renal failure or insufficiency, inability to gain IV access, pregnant or breast feeding, clinical suspicion of opioid dependence or abuse, and opiate use in 24 hours before presentation to ED.