This is a randomized, double-blinded, placebo-controlled, cross-over trial examining the effect of a series of two weekly intravenous infusions of lidocaine 4 mg/kg and ketamine 0.2 mg/kg in patients with moderate to severe opioid-refractory chronic cancer-related pain. The aim of this study is to investigate whether the lidocaine - ketamine (LK) regimen provides better analgesia that an active placebo of midazolam 0.02 mg/kg, in this population.
Age 18 years or more
Capacity to provide informed consent, ability to complete study assessments and comply with the study procedures
Meets the IASP definition for chronic cancer-related pain
Moderate or severe pain, defined as average pain of 4 or greater on an 11-point (0-10) NRS in the past 24h
Previous adverse reaction to ketamine, lidocaine or other amide-type local anesthetics, midazolam
Severe liver disease (Child Class B or C)
SGPT or SGOT >5 times the upper limit of normal
End stage kidney disease
National and Kapodistrian University of Athens
Lead sponsor
Attikon Hospital
Collaborator