Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
NCT ID: NCT01326325
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2011-07-31
2013-06-30
Brief Summary
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Detailed Description
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To show that low analgesic doses of ketamine in intravenous infusion during 4 days associated with opioids better relieve refractory cancer pain than opioids without ketamine.
This study is a prospective study, multicenter (11 centres), consisting of 3 phases:
* a randomized controlled double blind phase of 5 days with 2 parallel groups of 38 patients each : ketamine (in association with high opioids), in intravenous injection during 4 days, versus placebo (in association with high opioids), in intravenous injection during 4 days ;
* an open-label phase of maximum 4 days, during which the ketamine Panpharma® is administered in intravenous infusion to the hospitalized patients who are still having uncontrolled pain persisting or recurrent ;
* an observational phase : starting at the discharge of the patient, of a maximal period of 6 months.The inclusion period is during 18 months, the total duration of the study is 2 years.
76 patients are expected: 38 will be treated with opioids and ketamine; 38 will be treated with opioids and a placebo.
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 30 %.
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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ketamine
Ketamine PANFARMA
Ketamine
Drip continues of ketamine in intravenous injection included posology enters 0,5mg/kg /day and 2mg/kg/day during 4 days
Not Ketamine
NaCl
NaCl
Drip continues of NaCl 0,9% in intravenous injection during 4 days
Interventions
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Ketamine
Drip continues of ketamine in intravenous injection included posology enters 0,5mg/kg /day and 2mg/kg/day during 4 days
NaCl
Drip continues of NaCl 0,9% in intravenous injection during 4 days
Eligibility Criteria
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Inclusion Criteria
* Undergoing opioid treatment for 15 days at least
* Refractory pain (score higher than 5 on an 10-point numerical pain rating scale)
* Ability to score pain on a numerical pain rating scale
* Patient written agreement
Exclusion Criteria
* Methadone or other NMDA-antagonist treatment
* Karnofsky index under 10
* Pregnancy
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Sylvie ROSTAING-RIGATTIERI, MD
Role: PRINCIPAL_INVESTIGATOR
Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital
Locations
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Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital
Paris, Île-de-France Region, France
Countries
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References
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Other Identifiers
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P081242
Identifier Type: -
Identifier Source: org_study_id