Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Information source: Assistance Publique - Hôpitaux de Paris
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Ketamine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Sylvie ROSTAING-RIGATTIERI, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Summary
Long-term opioid therapy is commonly administered for the management of severe cancer pain.
Increasing doses of opioids are titrated against effects until analgesia is achieved or
intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor
antagonist, has been reported to improve analgesia in patients with uncontrolled pain
receiving high doses of opioids. This study aims at determining the effectiveness of
ketamine as an adjuvant to opioids in relieving cancer pain.
Clinical Details
Official title: Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Daily pain score on an 11-point numerical pain rating scale
Secondary outcome: 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
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hopital Saint Antoine, Paris 75012, France
Additional Information
Starting date: May 2007
Last updated: May 3, 2011
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