Ketamine Associated With Opioids in Refractory Cancer Pain Treatment (KETADOL)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment|
- Daily pain score on an 11-point numerical pain rating scale [ Time Frame: after 4 days ] [ Designated as safety issue: Yes ]
- Patient Global Impression of Change Clinical Global Impression of Change Daily sleep interference score Patient satisfaction of pain relief Opioids consumption Adverse effects of ketamine-opioids association [ Time Frame: during the 4 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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 score).
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 shift).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484484
|Hopital Saint Antoine|
|Paris, France, 75012|
|Principal Investigator:||Sylvie ROSTAING-RIGATTIERI, MD||Assistance Publique - Hôpitaux de Paris|