RecruitingACTRN12622000056796

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

Sponsor

Dr Michael Briffa

Enrollment

30 participants

Start Date

Dec 21, 2021

Study Type

Interventional

Conditions

Palliative Care Breakthrough Pain

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

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

People approaching the end of life in a hospice often experience episodes of sudden or unpredictable pain — called breakthrough pain — that require prompt administration of opioid medication by injection. The current method involves a nurse drawing up and administering a subcutaneous or intravenous injection each time this is needed, which takes time and creates logistical challenges around the clock. This feasibility study at the Laurel Hospice (Flinders Medical Centre) is evaluating a novel delivery device that could make the administration of breakthrough analgesics faster, safer, and more consistent. The study is assessing the device's safety, how well it manages pain, how easy it is for nursing staff to use, and how acceptable it is to patients, families, and carers. Eligibility includes patients admitted to the Laurel Hospice who are receiving subcutaneous or intravenous breakthrough analgesia at least four times per 24 hours, and are aged 18 or older. Nursing and medical staff at the hospice are also participants in the usability assessments. This is not a trial of a new drug — the medications remain the same — but rather a study of a better way to deliver them. Improving the speed and ease of breakthrough pain management could meaningfully improve comfort for people in their final days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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