Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000960459
Ethics application status
Approved
Date submitted
29/07/2025
Date registered
2/09/2025
Date last updated
2/09/2025
Date data sharing statement initially provided
2/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical audit of the long-term use of oral ketamine for management of chronic pain
Scientific title
Long-Term Outcomes From Oral Ketamine Therapy For Treatment Resistant Chronic Pain
Secondary ID [1] 315019 0
Nil Known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 338358 0
Condition category
Condition code
Anaesthesiology 334657 334657 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Questionnaires will be administered: Brief Pain Inventory, Depression and Anxiety Stress Scale, Pain Catastrophizing Scale and Pain Self-efficacy Questionnaire. Patients will also complete a check list of side effects from ketamine treatment. Demographic data will be extracted from Dr Salmons case notes, as well as other analgesia prescribed and patients perception of effects of treatment. Questionnaire responses will be compared with baseline questionnaires (PCS, PSEC, BPI and DASS ) completed at initial consultation when the patients first consults with Dr Salmon whenever that appointment occurred. The length of time each patients have been taking will vary, however patients consenting to the study are at least two years post commencement of ketamine therapy. The participating patients are only required to complete one set of questionnaires in addition to the initial (first consultation) questionnaires which is standard care. Patients are approached when attending clinic for follow-up appointments , or contacted by telephone.
Intervention code [1] 331618 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342333 0
A clinical audit to assess of patients to assess the safety and efficacy of long-term oral ketamine therapy for treating chronic pain, this is a composite outcome using the questionnaires specified below
Timepoint [1] 342333 0
As standard care all patients complete a DASS, PSEQ, BPI and PCS when first attending clinic to consult with Dr Salmon. Participants of this study consent to complete these same questionnaires on one occasion only at least 2 years post commencement on ketamine therapy, the length of time between each patients initial, standard care questionnaire and the study questionnaire will vary from patient to patient.
Primary outcome [2] 342334 0
Changes in prescribed analgesia other than ketamine (morphine equivalent doses)
Timepoint [2] 342334 0
From initial consultation, to at least two years post commencement of ketamine therapy.
Primary outcome [3] 342460 0
Side effects of ketamine
Timepoint [3] 342460 0
At least two years post commencement of ketamine
Secondary outcome [1] 450349 0
Participant satisfaction with ketamine therapy
Timepoint [1] 450349 0
At least two years post commencement of ketamine therapy

Eligibility
Key inclusion criteria
All patients with treatment resistant severe chronic pain treated by Dr Salmon for at least two years with oral ketamine therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent. Less than 2 years treatment with ketamine oral medication.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/07/2025
Date of last participant enrolment
Anticipated
23/07/2027
Actual
Date of last data collection
Anticipated
24/07/2027
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 44461 0
6011 - Cottesloe

Funding & Sponsors
Funding source category [1] 319582 0
University
Name [1] 319582 0
Murdoch University, 90 South Street Murdoch Western Australia 6150 Australia
Country [1] 319582 0
Australia
Funding source category [2] 319687 0
Commercial sector/Industry
Name [2] 319687 0
Nevro Corp 1800 Bridge Parkway, Redwood City, CA 94065
Country [2] 319687 0
United States of America
Primary sponsor type
Individual
Name
Dr John Salmon, PainCare Perth, Parkland House 2/89 Forrest Street Cottesloe WA 6011
Address
Country
Australia
Secondary sponsor category [1] 322192 0
None
Name [1] 322192 0
N/A
Address [1] 322192 0
Country [1] 322192 0
Other collaborator category [1] 283602 0
Individual
Name [1] 283602 0
Professor Peter Drummond Murdoch University 90 South Street Murdoch WA 6150
Address [1] 283602 0
Country [1] 283602 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318146 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 318146 0
Ethics committee country [1] 318146 0
Australia
Date submitted for ethics approval [1] 318146 0
07/07/2025
Approval date [1] 318146 0
14/07/2025
Ethics approval number [1] 318146 0

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

Contacts
Principal investigator
Name 143262 0
Dr John Salmon
Address 143262 0
PainCare Perth Parkland House 2/89 Forrest Street Cottesloe, WA 6011
Country 143262 0
Australia
Phone 143262 0
+61 8 92846005
Fax 143262 0
Email 143262 0
[email protected]
Contact person for public queries
Name 143263 0
Dr John Salmon
Address 143263 0
Paincare Parkland House Perth 2/89 Forrest Street, Forrest Street Cottesloe Western Australia 6011
Country 143263 0
Australia
Phone 143263 0
+61 8 92846005
Fax 143263 0
Email 143263 0
[email protected]
Contact person for scientific queries
Name 143264 0
John Salmon
Address 143264 0
PainCare Perth Parkland House 2/89 Forrest Street Cottesloe WA 6011
Country 143264 0
Australia
Phone 143264 0
+61 8 92 846005
Fax 143264 0
Email 143264 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.