Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001305718
Ethics application status
Approved
Date submitted
15/09/2022
Date registered
10/10/2022
Date last updated
10/10/2022
Date data sharing statement initially provided
10/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Burst Ketamine Infusions for Patients with Chronic Refractory Pain
Scientific title
A Pilot Longitudinal Study of Repeated Burst Ketamine Infusions in
Outpatients for Patients with Chronic Refractory Pain
Secondary ID [1] 307976 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 327644 0
Condition category
Condition code
Anaesthesiology 324730 324730 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three consecutive subcutaneous burst ketamine infusions of four hours of a total
dose of 1.5mg/kg (based on lean body weight), 2-3 weeks (depending on patient and bed availability) apart for chronic pain in an outpatient care setting. Non-attendance of intervention will be noted on study record at the time.
Intervention code [1] 324435 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332548 0
Long-term analgesic effect based on Brief Pain Inventory pain severity score between baseline and 12 week follow-up
Timepoint [1] 332548 0
12 week follow up from last infusion
Secondary outcome [1] 413878 0
Change in Brief Pain Inventroy - pain interference
Timepoint [1] 413878 0
Between baseline and 8 week and 12 week follow up from last infusion
Secondary outcome [2] 413939 0
Change in Pain Self-Efficacy Questionnaire
Timepoint [2] 413939 0
Between baseline and 8 week and 12 week follow up from last infusion
Secondary outcome [3] 413940 0
Change in depression, anxiety and stress scores on DASS21
Timepoint [3] 413940 0
Between baseline and 8 week and 12 week follow up from last infusion
Secondary outcome [4] 413941 0
Change in pain catastrophisation on Pain Catastrophisation Scale
Timepoint [4] 413941 0
Between baseline and 8 week and 12 week follow up from last infusion

Eligibility
Key inclusion criteria
Australian adults aged 18+ with chronic refractory pain of >6 months classified as:
- Complex regional pain syndrome
- Chronic widespread body or nociplastic pain
- Neuropathic pain (central, peripheral and mixed)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged less than 18
- Unable to speak, read or write in English
- Contraindications or known allergy to ketamine
o Uncontrolled hypertension
o Significant coronary disease
o Severe liver dysfunction
o Pregnancy/lactation
- Patients with severe and unstable psychological or psychiatric conditions e.g. major psychosis or suicidality
- Patients who have had a major interventional pain procedure (i.e., spinal cord stimulator or
intrathecal drug infusion)
- Patients with ongoing legal litigation or proceeding regarding their pain condition
- Patients with a known drug dependency or substance use disorder related to ketamine or other psycho-stimulant drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit and treat 28 patients allowing for 9 drop-outs or partial-completers (30% attrition). This is a pilot study and estimate of sample size was based on previous ketamine study conducted by the research team and existing literature.

The primary outcome of the study is the change in BPI pain severity score between baseline and the 12-week follow-up. This will be analysed by using a Wilcoxon sign-rank test, with a statistical significance level of a = 0.05. The primary analyses for the other outcomes will be conducted in the same way.

Secondary analyses will include longitudinal linear models to estimate mean changes in the outcome measures between baseline and the subsequent follow-up visits.

A detailed analysis plan, including methods to account for missing data, will be created prior to the commencement of data analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/08/2022
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
28
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23164 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 38525 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 312245 0
Hospital
Name [1] 312245 0
Prince of Wales Hospital - Pain Management Department
Country [1] 312245 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital - Pain Management Department
Address
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 313782 0
None
Name [1] 313782 0
Address [1] 313782 0
Country [1] 313782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311620 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 311620 0
Ethics committee country [1] 311620 0
Australia
Date submitted for ethics approval [1] 311620 0
Approval date [1] 311620 0
22/06/2022
Ethics approval number [1] 311620 0
2021/ETH11745: A Pilot Longitudinal Study of Repeated Burst Ketamine Infusions in Outpatients for Patients with Chronic Refractory Pain

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

Contacts
Principal investigator
Name 121746 0
Dr Karen Chan
Address 121746 0
Pain Management Department
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 121746 0
Australia
Phone 121746 0
+61 293822863
Fax 121746 0
Email 121746 0
[email protected]
Contact person for public queries
Name 121747 0
Karen Chan
Address 121747 0
Pain Management Department
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 121747 0
Australia
Phone 121747 0
+61 293822863
Fax 121747 0
Email 121747 0
[email protected]
Contact person for scientific queries
Name 121748 0
Karen Chan
Address 121748 0
Pain Management Department
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 121748 0
Australia
Phone 121748 0
+61 293822863
Fax 121748 0
Email 121748 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
Ethics approval for this has not been obtained


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.