None listed
Conditions
Brief summary
This study looks at the effectiveness of the pain-killing drug ketamine in people with widespread cancer who are receiving palliative care and have difficult cancer pain that does not respond well to opioid drugs. Who is it for? You can join this study if you have widespread cancer and are receiving palliative care, and have difficult cancer pain that does not respond well to opioid (morphine-like) drugs. Trial details Participants will be divided into two groups. One group will receive five days of treatment with increasing doses of ketamine given under the skin (sub-cutaneously), and the other will receive a non-active compound (placebo) also given under the skin. Blood samples will be collected. The study will assess pain control, quality of life, side effects from ketamine, and reduction in the need for usual pain medicines. The study nurses and the doctors and nurses in the ward will monitor all participants closely for any unexpected problems and to ensure that pain is managed appropriately. Ketamine may be helpful for pain related to cancer, especially pain resulting from nerve damage. However studies to date are incomplete and evidence is needed to support continued clinical use. It is hoped that after this study, if ketamine is proven safe and effective in difficult cancer pain, it will become more easily available for Australian cancer patients.
Interventions
phase III randomised, double blind, placebo controlled trial of ketamine 100mg to 300 mg then 500mg (if not responding) delivered by subcutaneous infusion over 24 hours for 5 days.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
•age >18 years •pain related to cancer or its treatment •moderate to severe pain •patients with primarily nociceptive pain (Leeds Assessment of Neuropathic Symptoms and Signs score <12), or patients with predominantly neuropathic pain (Leeds Assessment of Neuropathic Symptoms and Signs score >12) treated appropriately •stable backgound opioid dose •stable co-analgesics during the study period •patient is able to give fully informed written consent
Exclusion criteria
Previous ketamine use Unstable pain, or undergoing active treatment to reduce pain (surgery, chemotherapy, radiotherapy) Medical history places patient at risk of known adverse reactions Pregnacny/ lactation Previous recreaional drug history Recent Monoamine oxidase inhibitors (non-reversible monoamine oxidase inhibitors are excluded for 4 weeks, reversible monoamine oxidase inhibitors are excluded for 2 days).
Outcome results
None listed