Ketamine for cancer pain
ACTRN12607000501448
Treatment
Phase 3
Government body,Commonwealth Department of Health and Ageing
Prof Prof Janet Hardy
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 day .... Read more
•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
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).
No
Sample Size 150
Min. age 18 Years
Max. age -2147483648 No limit
Sex Both males and females
Condition category Pain from cancer or cancer treatment
Condition code Cancer
Intervention code Treatment: Drugs
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.
Control group Placebo
Normal Saline 15 mls, over subcutaneous infusion over 24 hours for 5 days.
Outcome: The primary outcome is the pain score on day 6.Timepoint: Day 6
yes
Primary and secondary outcome IPD Data Dictionary Protocol
01/06/2023 to 01/06/2027
Researchers undertaking secondary research
Those analyses described in approved proposals only