Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001559303
Ethics application status
Approved
Date submitted
12/10/2017
Date registered
15/11/2017
Date last updated
26/09/2022
Date data sharing statement initially provided
15/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient controlled analgesia in emergency departments
Scientific title
Determining the feasibility of using patient controlled analgesia in emergency departments:
A feasibility pilot randomised controlled trial
Secondary ID [1] 291780 0
None
Universal Trial Number (UTN)
Trial acronym
PCAED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management 303005 0
Patient controlled analgaesia 303006 0
Condition category
Condition code
Anaesthesiology 304637 304637 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297890 0
Treatment: Devices
Comparator / control treatment
The control group will receive treatment as usual. This consists of an intravenous opioid (usually fentanyl or morphine) being titrated and administered to effect by the attending nurse through a valid medication order from a doctor. This will occur for four hours or until the participant is discharged or transferred out of the ED.
Control group
Active

Outcomes
Primary outcome [1] 301886 0
Establish the feasibility of conducting a larger and fully powered randomised controlled trial. Feasibility will be assessed by the following criteria:

a. Feasibility of recruitment will be evidenced by at least 70% of eligible patients providing informed consent

b. 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)

c. Adherence to study protocol will be evidenced by at least 80% of the total pain scores recorded on the data collection sheet

d. Acceptability of treatment by nursing and medical staff will be assessed in a survey (designed specifically for this study) to staff who were involved in the care of a patient in this trial
Timepoint [1] 301886 0
End of trial period.
Secondary outcome [1] 339693 0
Determine patient satisfaction with pain management by comparing patient satisfaction scores on a 10 point scale.
Timepoint [1] 339693 0
End of participation (either after four hours or when the participant is discharged or transferred out of the ED).
Secondary outcome [2] 339694 0
Determine the frequency and types of adverse events experienced with pain management by comparing data on patient-reported adverse events.
Adverse events will be assessed through the nurse verbally asking the participant if they experienced any adverse events, and the nurse writing down the response on the data collection sheet.
Timepoint [2] 339694 0
End of participation (either after four hours or when the participant is discharged or transferred out of the ED).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocations will be stored in sequentially numbered, opaque, sealed envelopes that will be made available to the attending nurse or researcher upon enrolment of a participant. This ensures the random sequence is concealed before a group is assigned. Envelopes will be numbered in advanced and opened sequentially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated allocation sequence produced by an independent researcher.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a feasibility pilot RCT, 12 participants will be recruited into each group (total of 24 participants). Studies recommend sample sizes between 24 and 50 for feasibility studies (Julious, 2005; Sim & Lewis, 2012) and this number was confirmed as suitable by a university biostatistician. This sample size was chosen for pragmatic reasons: the study site has a smaller number of patient presentations compared to other EDs and this feasibility pilot RCT is one phase of research which comprises of several phases with varying degrees of complexity.

Data analysis
Quantitative data will be analysed using univariate and multivariate statistical techniques with SPSS data analysis software (version 24). Analyses will be two-tailed and statistical significance will be defined by the standard 0.05 significance criterion for all tests. Feasibility will be assessed with descriptive statistics. Qualitative data (questionnaires to ED staff who are involved in the feasibility pilot RCT) will be analysed thematically. QRS Nivo is a qualitative data analysis program that will be used for this research.

References
Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4(4), 287–291. doi:10.1002/pst.185
Sim, J., & Lewis, M. (2012). The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. Journal of Clinical Epidemiology, 65(3), 301–308. doi:10.1016/j.jclinepi.2011.07.011

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2021
Actual
19/10/2020
Date of last participant enrolment
Anticipated
30/09/2021
Actual
16/12/2020
Date of last data collection
Anticipated
30/09/2021
Actual
16/12/2020
Sample size
Target
24
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9180 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 17816 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 296283 0
Hospital
Name [1] 296283 0
St John of God Hospital Centre for Nursing and Midwifery Research
Country [1] 296283 0
Australia
Primary sponsor type
Individual
Name
Natasya Raja (PhD Candidate)
Address
St John of God Hospital Murdoch
Centre for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 295205 0
Individual
Name [1] 295205 0
Dr Gail Ross-Adjie (principal supervisor)
Address [1] 295205 0
St John of God Hospital Murdoch
Centre for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch WA 6150
Country [1] 295205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297516 0
University of Notre Dame Australia HREC
Ethics committee address [1] 297516 0
Ethics committee country [1] 297516 0
Australia
Date submitted for ethics approval [1] 297516 0
28/08/2020
Approval date [1] 297516 0
29/09/2020
Ethics approval number [1] 297516 0
2020-141F
Ethics committee name [2] 298805 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 298805 0
Ethics committee country [2] 298805 0
Australia
Date submitted for ethics approval [2] 298805 0
02/09/2020
Approval date [2] 298805 0
02/10/2020
Ethics approval number [2] 298805 0
1722

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74290 0
Ms Natasya Raja
Address 74290 0
St John of God Hospital Murdoch
Center for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch 6150
Murdoch WA 6150
Country 74290 0
Australia
Phone 74290 0
+61 8 94389005
Fax 74290 0
Email 74290 0
[email protected]
Contact person for public queries
Name 74291 0
Natasya Raja
Address 74291 0
St John of God Hospital Murdoch
Center for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch 6150
Murdoch WA 6150
Country 74291 0
Australia
Phone 74291 0
+61 8 94389005
Fax 74291 0
Email 74291 0
[email protected]
Contact person for scientific queries
Name 74292 0
Natasya Raja
Address 74292 0
St John of God Hospital Murdoch
Center for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch 6150
Murdoch WA 6150
Country 74292 0
Australia
Phone 74292 0
+61 8 94389005
Fax 74292 0
Email 74292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared as this is a small pilot feasibility randomised controlled trial with a small sample size. Providing this individual information may render the data identifiable and breech confidentiality and privacy requirements.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.