Sublingual Ketamine as Breakthrough Analgesia in Patients with Advanced Cancer-A Feasibility Randomised Controlled...

Area of Science:

• Oncology
• Pain Management
• Pharmacology

Background:

• Advanced cancer frequently causes moderate-to-severe pain requiring effective breakthrough analgesia.
• Current breakthrough pain management often involves opioids, which can have significant side effects.
• Sublingual ketamine is being explored as a potential alternative or adjunct for cancer pain.

Purpose of the Study:

• To assess the feasibility of a larger definitive study on sublingual ketamine's efficacy.
• To evaluate sublingual ketamine as a first-line breakthrough analgesic for advanced cancer pain.
• To determine the attrition rate in a pilot randomized controlled trial.

Main Methods:

• Prospective, double-blind, randomized, placebo-controlled, repeated cross-over trial.
• Patients (≥18 years) with advanced cancer pain requiring opioid analgesia were randomized.
• Primary outcome: attrition rate (completion of two treatment cycles over 12 months).

Main Results:

• Only 11 of 64 referred patients completed the intervention; the feasibility criterion of 24 patients was not met.
• Patients had difficulty distinguishing between ketamine and placebo.
• Ketamine showed higher efficacy for pain reduction and improved quality of life compared to placebo.

Conclusions:

• The current study design is infeasible for a larger trial due to high attrition.
• The dose of sublingual ketamine may have been too low, indicated by poor discrimination and minimal adverse effects.
• Future research should refine target populations and consider disease progression.