Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease
To show that low analgesic doses of ketamine in intravenous infusion during 4 days
associated with opioids better relieve refractory cancer pain than opioids without ketamine.
This study is a prospective study, multicenter (11 centres), consisting of 3 phases:
- a randomized controlled double blind phase of 5 days with 2 parallel groups of 38
patients each : ketamine (in association with high opioids), in intravenous injection
during 4 days, versus placebo (in association with high opioids), in intravenous
injection during 4 days ;
- an open-label phase of maximum 4 days, during which the ketamine Panpharma® is
administered in intravenous infusion to the hospitalized patients who are still having
uncontrolled pain persisting or recurrent ;
- an observational phase : starting at the discharge of the patient, of a maximal period
of 6 months.The inclusion period is during 18 months, the total duration of the study
is 2 years.
76 patients are expected: 38 will be treated with opioids and ketamine; 38 will be
treated with opioids and a placebo.
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 30 %.
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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The percentage of reduction of the daily average score of painful intensity after 4 days of treatment (to J4), with regard to the basic value to J0
The daily average score of painful intensity being the score of painful intensity of the previous 24 hours, determined by the patient on a digital scale(ladder) validated from 0 to 10
Sylvie ROSTAING-RIGATTIERI, MD
Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)