Ketamine Associated With Opioids in Refractory Cancer Pain Treatment (KETADOL)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00484484
First received: June 8, 2007
Last updated: May 3, 2011
Last verified: June 2007

June 8, 2007
May 3, 2011
May 2007
September 2009   (final data collection date for primary outcome measure)
Daily pain score on an 11-point numerical pain rating scale [ Time Frame: after 4 days ] [ Designated as safety issue: Yes ]
Daily pain score on an 11-point numerical pain rating scale [ Time Frame: after 4 days ]
Complete list of historical versions of study NCT00484484 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
Drug: Ketamine
Ketamine
Other Name: Ketamine
  • Experimental: 1
    Ketamine
    Intervention: Drug: Ketamine
  • Experimental: 2
    Ketamine
    Intervention: Drug: Ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00484484
P051048
Yes
Aurémie GUIMFACK, Department of Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Sylvie ROSTAING-RIGATTIERI, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP