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
  Purpose

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 Intervention Phase
Pain
Drug: Ketamine
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Daily pain score on an 11-point numerical pain rating scale [ Time Frame: after 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: May 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ketamine
Drug: Ketamine
Ketamine
Other Name: Ketamine
Experimental: 2
Ketamine
Drug: Ketamine
Ketamine
Other Name: Ketamine

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484484

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

No publications provided

Responsible Party: Aurémie GUIMFACK, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00484484     History of Changes
Other Study ID Numbers: P051048
Study First Received: June 8, 2007
Last Updated: May 3, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Ketamine
Analgesics, Opioid
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014