Authors
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Dr Lana Ferguson -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: Arm 1 Dexmedetomidine infusion as per department guidelines (as per Waikato DHB Subcutaneous dexmedetomidine infusion guideline) starting at 0.4 mcg/kg/hr subcutaneously via continuous ambulatory delivery device (CADD‐solis) or Alaris infusion pump, titrated to acceptable symptom control. Titration to a maximum of 1.4mcg/kg/hr over a duration fo 72 hours (treatment may continue beyond 72 hours, but data will not be collected after this time point) Arm 2 Standard of care, which, for the purposes of this study, refers to the use of antipsychotic and/or benzodiazepine medication as per the treating clinician with reference to department guidelines Treatment Failure and Subsequent Management: Treatment failure is defined as the addition of, or change to, drug therapy different to the initial starting strategy. If agitation is not adequately controlled (i.e., RASS‐PAL score of 0 to ‐2 is not achieved), the treating clinician can initiate other treatment as clinically appropriate, including treatment included in the other study arm. This would be deemed a failure of the original treatment arm. The patient will not be withdrawn from the study if treatment failure occurs, data on second‐line therapy will continue to be collected. Assessment Tools: Agitation in the palliative care setting will be assessed using the Richmond‐Agitation‐Sedation Scale (RASS‐PAL). This is a validated tool used to assess levels of agitation and sedation, modified for palliative care inpatients.. Use of the scale allows consistent measurement of sedation level in line with the aim to achieve a RASS‐PAL score of =0 in the management of problematic agitation. All patients will have appropriate care in other respects, as per the treating clinician, including: CONDITION: Agitation; ; Agitation Neurological ‐ Other neurological disorders PRIMARY OUTCOME: The mean time to achieving a RASS‐PAL score = 0.; Compare time infusion was started with time RASS‐PAL score = 0 achieved; this will be achieved by reviewing medical records, electronic prescribing programme (Medi‐map) and data recorded on case report forms.[Study duration of 72 hours from initiation of treatment] SECONDARY OUTCOME: Duration of time at RASS‐PAL = 0 using the primary strategy; ; determined by review of medical records and case report forms ; RASS‐PAL ; ; [72 hours from initiation of treatment] Mean time for second‐line therapy to achieve a RASS‐PAL score = 0. ; Data is collected through review of medical notes, nurse records, completed case record forms, as per our research protocol. ; Hourly RASS‐Pal score will be taken for 24 hours then 4 hourly for the next 48 hours (total 72 hours from initiation of treatment.[72 hours from initiation of treatment] Proportion of patients with RASS‐PAL scores >0 over the first 48 hours; ; Data is collected through review of medical notes, nurse records, completed case record forms, review of electronic prescribing platform, as per our research protocol.[48 hours from initiation of treatment] Second‐line therapy used in each group; ; Data is collected through review of medical notes, nurse records, completed case record forms, review of electronic prescribing platform, as per our research protocol.[72 hours from initiation of treatment] Time to treatment failure (TTF), defined as the time from treatment initiation to the addition of, or change to, drug therapy different to the initial treatment strategy; ; 1. Examples of known possible adverse effects are provided in the research protocol, patient information leaflet and precedex medsafe datasheet. ; ; Dexmedetomidine is generally well tolerated, side effects which can occur include: ; • Hypotension ; • Hypertension ; • Dry mouth/thirst ; Data is collected through review of medical notes, nurse records, completed case record forms, review of electronic prescribing platform, as per our research protocol.[72 hours from initiation of treatment] Tolerability and adverse effects of dexmedetomidine infusion. ; • Bradycardia ; • Nausea ; • Fever ; ; ; 2. Adverse effect will graded using the common terminology criteria for adverse events (as per research protocol)[72 hours from initiation of treatment] INCLUSION CRITERIA: • Palliative diagnosis with a prognosis of 6 months or less; • Patient has agitation requiring pharmacological management (RASS‐PAL greater than or equal to +2); • 18 years and over.
Epistemonikos ID: 371e6b4277af57aec6edb100f6a09c653574d618
First added on: Aug 25, 2024