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

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Cancer, Refractory pain, Uncontrolled pain, Ketamine, Uncontrolled cancer pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Saint Antoine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Ketamine

Ketamine

Outcomes

Primary Outcome Measures

Daily pain score on an 11-point numerical pain rating scale

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

Full Information

First Posted
June 8, 2007
Last Updated
May 3, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00484484
Brief Title
Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Acronym
KETADOL
Official Title
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Cancer, Refractory pain, Uncontrolled pain, Ketamine, Uncontrolled cancer pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ketamine
Arm Title
2
Arm Type
Experimental
Arm Description
Ketamine
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine
Primary Outcome Measure Information:
Title
Daily pain score on an 11-point numerical pain rating scale
Time Frame
after 4 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie ROSTAING-RIGATTIERI, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

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Ketamine Associated With Opioids in Refractory Cancer Pain Treatment

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