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Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment


Phase 3
18 Years
N/A
Not Enrolling
Both
Pain

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Trial Information

Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

after 4 days

Safety Issue:

Yes

Principal Investigator

Sylvie ROSTAING-RIGATTIERI, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P051048

NCT ID:

NCT00484484

Start Date:

May 2007

Completion Date:

September 2009

Related Keywords:

  • Pain
  • Cancer
  • Refractory pain
  • Uncontrolled pain
  • Ketamine
  • Uncontrolled cancer pain

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