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Feasibility study for a novel approach to delivery of breakthrough analgesics in palliative care

Feasibility study for a novel approach to delivery of breakthrough analgesics in palliative care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000056796
Enrollment
2
Registered
2022-01-18
Start date
2021-12-21
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pain is the most common symptom experienced by people at the end of life in an inpatient hospice setting. In nearly all cases, a person who is dying receives analgesics, usually opioid, including bolus injection of breakthrough analgesic to manage incidental pain. Our aim is to evaluate the safety, efficacy, usability and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients. 1. Safety – evaluate the safety of a novel method for administering breakthrough analgesics by monitoring adverse events associated with equipment, adherence to regulatory practices, audit of prescribing and administration practices 2. Efficacy – assessment and comparison of opioid dose, total MED, time in motion and use of other medications for breakthrough dosing such as anti emetics and anxiolytics 3. Usability – survey of staff about use of equipment and the method of administration 4. Acceptability- survey of staff, family, carers about experience

Interventions

The aim is to evaluate the safety, efficacy, usability, and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients using a computerised patient controlled analgesia device. Once consent has been granted an Agilia device will be ordered, programmed, and attached via subcutaneous cannula to the participant. While the device is insitu it will automatically collect data, including number of times the device was accessed, number of doses delivered, total amo

The aim is to evaluate the safety, efficacy, usability, and acceptance of a novel modality to administer breakthrough analgesics in palliative care patients using a computerised patient controlled analgesia device. Once consent has been granted an Agilia device will be ordered, programmed, and attached via subcutaneous cannula to the participant. While the device is insitu it will automatically collect data, including number of times the device was accessed, number of doses delivered, total amount of medication delivered and if any device associated adverse events or errors occurred (these include disruption to flow in the line, increase in pressure in the syringe, for example). Palliative care physicians, palliative care nurses in collaboration with the research nurse, will administer the intervention. The duration of the intervention/use of device for administration will be determined by end of life period of the patient. Participants will receive their usual breakthrough medication using the device, with no changes to their medications involved in this study. The medication in the device is the same medication they would normally receive if the device was not in use. The staff caring for the patient in the hospice will assess their pain regularly and discuss the need for the patient to have medication to help with pain as they normally would. A time in motion audit will be repeated to enable a comparison to the pre-intervention data

Sponsors

Dr Michael Briffa
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Staff- employed as a Registered Nurse or Medical Officer at Flinders Medical Centre and working at Laurel Hospice Patients - Admitted patients to the Laurel Hospice receiving intermittent analgesics via subcutaneous or intravenous injection who are over 18.

Exclusion criteria

Patients not receiving breakthrough analgesia Patient receiving less than four breakthrough analgesia doses per 24 hours.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026