- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00484484
Ketamine Associated With Opioids in Refractory Cancer Pain Treatment (KETADOL)
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Study Overview
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75012
- Hopital Saint Antoine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hospitalised cancer patients (informed and conscious of the cancer diagnostic)
- Undergoing opioid treatment for one month at least
- Refractory pain (score higher than 5 on an 11-point numerical pain rating scale)
- Ability to score pain on a numerical pain rating scale
- Patient written agreement
Exclusion Criteria:
- Ketamine contraindications
- Methadone or other NMDA-antagonist treatment
- Karnofsky index under 10
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Ketamine
|
Ketamine
|
Experimental: 2
Ketamine
|
Ketamine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily pain score on an 11-point numerical pain rating scale
Time Frame: after 4 days
|
after 4 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
during the 4 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sylvie ROSTAING-RIGATTIERI, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Cancer Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- P051048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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