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Drip continues of ketamine in intravenous injection included posology enters 0,5mg/kg /day and 2mg/kg/day during 4 days

Drip continues of NaCl 0,9% in intravenous injection during 4 days

NaCl

Sylvie ROSTAING-RIGATTIERI, MD

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.

Main objective:

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).

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

Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease

The daily average score of painful intensity being the score of painful intensity of the previous 24 hours, determined by the patient on a digital scale(ladder) validated from 0 to 10

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Assistance Publique - Hôpitaux de Paris

Nervous System Diseases

Neurologic Manifestations

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment	NCT01326325	Pain	Ketamine NaCl	18 Years -	Assistance Publique - Hôpitaux de Paris
Ketamine Associated With Opioids in Refractory Cancer Pain Treatment	NCT00484484	Pain	Ketamine	18 Years -	Assistance Publique - Hôpitaux de Paris
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment	NCT01326325	Pain	Ketamine NaCl	18 Years -	Assistance Publique - Hôpitaux de Paris
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment	NCT01326325	Pain	Ketamine NaCl	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for uncontrolled pain