Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Main objective :
To show that low analgesic doses of ketamine associated with opioids better relieve
refractory cancer pain than opioids without ketamine.
Secondary objectives :
- Determine whether ketamine use allows to reduce opioid consumption
- Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo.
100 patients are expected : 50 will be treated with opioids and ketamine ; 50 will be
treated with opioids and a placebo.
Treatment will be administered for 4 days. Patients will be followed-up for 5 days.
Success is defined by a decrease of the daily pain score of 50 % after 4 days. The expected
rate of success in the placebo group is 10 % whereas the expected rate of success in the
ketamine group is 35 %.
Primary outcome (pain score on a 11-point numerical scale) will be evaluated everyday as
well as secondary outcomes (patient and clinician global impression of change, opioid
consumption, adverse reactions, patient satisfaction on pain relief, sleep interference
Vital parameters (cardiac frequency, respiratory frequency and arterial blood pressure) will
be checked everyday, many times a day : every hour for the four hours after the beginning of
the treatment and then, every four hours ; every hour for the two hours following a dose
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Daily pain score on an 11-point numerical pain rating scale
after 4 days
Sylvie ROSTAING-RIGATTIERI, MD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health