Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000022763
Ethics application status
Not yet submitted
Date submitted
4/01/2013
Date registered
8/01/2013
Date last updated
8/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Evaluation of the Clinical Utility of Ketamine in Pain Desensitisation in Chronic Pain
Scientific title
Efficacy of Ketamine for Normalising Pain Sensitivity and Responsiveness to Opioids in Female Patients with either Multiple Sclerosis or Complex Regional Pain Syndrome
Secondary ID [1] 281726 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 288023 0
Complex Regional Pain Syndrome 288024 0
Condition category
Condition code
Anaesthesiology 288400 288400 0 0
Pain management
Neurological 288419 288419 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
i) Chronic Pain Group
Female patients with either Multiple Sclerosis or Complex Regional Pain Syndrome will be prescribed "Burst Ketamine" as part of their normal patient care programme. This treatment is a five-day inpatient procedure, in which ketamine is administered intravenously (or subcutaneously when IV route has failed) at a sub-anaesthetic dose (~7-40mg/hr), whilst an opioid (e.g. 10 mg oxycontin) is concurrently given. The aim of this project (an open label prospective audit) is to document the use of this treatment by assessing responsiveness to pain, as well as aspects fundamental to quality of life (e.g. mood, anxiety, sleep quality, cognition) both 1 week prior to “Burst Ketamine”, as well as during a 12 week follow-up.

ii) Normative Comparison Control Group
A separate sample of female control participants, who don’t have chronic pain, will be recruited to provide normative data along each measure of interest. These participants will not be required to undergo the “Burst Ketamine” procedure, however will complete all assessments relating to pain, mood, anxiety, sleep quality, and cognition.
Intervention code [1] 286263 0
Treatment: Drugs
Comparator / control treatment
A sample of healthy (i.e. chronic pain free), age-matched, female volunteers will be recruited from the general public. These participants will not be required to undergo the “Burst Ketamine” treatment, but will be asked to complete all assessments (i.e. pain sensitivity, mood, anxiety, sleep quality, cognition) as a way of providing normative comparison data by which the chronic pain patients can be compared against.
Control group
Active

Outcomes
Primary outcome [1] 288573 0
Pain sensitivity in response to mechanical (von Frey filaments), thermal (hot plate), and pressure stimuli (odometer).
Timepoint [1] 288573 0
One week prior to Burst Ketamine treatment (i.e. baseline), and at one, three, six, and twelve weeks post-treatment
Secondary outcome [1] 300487 0
Pen-and-paper questionnaires and tests designed to assess:
Mood & Anxiety (HADS, DASS-42)
Sleep Quality (Epworth scale and PSQI)
Cognition (RAVLT, Rey's Complex Figure Test, TMT etc.)
Timepoint [1] 300487 0
One week prior to the “Burst Ketamine” treatment (i.e. baseline), and at one, three, six, and twelve weeks post-treatment.

Eligibility
Key inclusion criteria
Negative pregnancy test at start of experiment
Female
Multiple Sclerosis or Complex Regional Pain Syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to ketamine
History of moderate-to-severe brain injury, alcohol abuse.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286515 0
University
Name [1] 286515 0
Monash University Postgraduate Research Funds
Country [1] 286515 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Wellington Rd, Clayton
Clayton, VIC (3800)
Country
Australia
Secondary sponsor category [1] 285302 0
None
Name [1] 285302 0
Address [1] 285302 0
Country [1] 285302 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288588 0
Southern Health HREC
Ethics committee address [1] 288588 0
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 288588 0
Australia
Date submitted for ethics approval [1] 288588 0
21/01/2013
Approval date [1] 288588 0
Ethics approval number [1] 288588 0
12191A

Summary
Brief summary
The benefits of an existing inpatient treatment regimen involving ketamine infusion for the purpose of pain desensitisation/opioid detoxification will be documented. A sample of approximately 40 female chronic pain patients with either multiple sclerosis (n=20) or complex regional pain (n=20) will be evaluated before and after a 5-day inpatient ketamine infusion procedure (termed “Burst Ketamine”). The procedure itself involves the patient receiving an intravenous infusion of ketamine, administered within a subanaesthetic dose range, whilst an opioid is concurrently given. The endpoints of interest include patient pain thresholds (evaluating the degree of hypersensitivity/allodynia before and after the ketamine protocol), sensitivity to opioid analgesia, quality of life measures, mental health assessment, sleep quality and cognitive processing measures. Additionally, these endpoints will also be assessed in healthy female volunteer participants (n=20) to provide normative comparisons for which the pain patients can be compared against. Collectively, the pre- and post-treatment measures will enable us to determine whether: 1) ketamine therapy increases pain thresholds in patients, 2) ketamine therapy normalises sensitivity to opioids, 3) quality of life, mental health, sleep quality and cognitive measures improve subsequent to ketamine therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36818 0
Dr Jillian Broadbear
Address 36818 0
Monash University (Clayton)
Wellington Rd
Clayton VIC 3800
Country 36818 0
Australia
Phone 36818 0
+61 3 99053903
Fax 36818 0
Email 36818 0
[email protected]
Contact person for public queries
Name 36819 0
Malar Thiagarajan
Address 36819 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 36819 0
Australia
Phone 36819 0
+61 3 95944612
Fax 36819 0
Email 36819 0
[email protected]
Contact person for scientific queries
Name 36820 0
Jillian Broadbear
Address 36820 0
Monash University
Wellington Rd
Clayton VIC 3800
Country 36820 0
Australia
Phone 36820 0
+61 3 99053903
Fax 36820 0
Email 36820 0
[email protected]

No information has been provided regarding IPD availability


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.