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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484484
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : May 4, 2011
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Study Start Date : May 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: 1
Drug: Ketamine

Experimental: 2
Drug: Ketamine

Primary Outcome Measures :
  1. Daily pain score on an 11-point numerical pain rating scale [ Time Frame: after 4 days ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484484

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Hopital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Sylvie ROSTAING-RIGATTIERI, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Aurémie GUIMFACK, Department of Clinical Research of developpement Identifier: NCT00484484     History of Changes
Other Study ID Numbers: P051048
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: June 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Refractory pain
Uncontrolled pain
Uncontrolled cancer pain

Additional relevant MeSH terms:
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Cancer Pain
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action