LOW-DOSE KETAMINE AS ADJUVANT TREATMENT TO MORPHINE IN NEUROPATHIC CANCER PAIN.

INTERVENTION: Trade Name: Ketalar Pharmaceutical Form: Solution for infusion INN or Proposed INN: KETAMINE CAS Number: 6740‐88‐1 Current Sponsor code: Keta‐1 Concentration unit: mg/g milligram(s)/gram Concentration type: range Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Subcutaneous use CONDITION: Therapeutic area: Diseases [C] ‐ Cancer [C04] Treatment of neuropathic cancer pain. PRIMARY OUTCOME: Main Objective: To see whether the addition of low‐dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with refractory neuropathic cancer pain. Primary end point(s): Change in pain intensity compared to baseline. Significant reduction in pain intensity will be defined as at least 30% reduction in Numeric Rating Scale (NRS) score compared to baseline. Secondary Objective: To see whether the addition of low‐dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with refractory neuropathic cancer pain. Timepoint(s) of evaluation of this end point: After 4 days of treatment; 2 days with Ketalar and 2 days with placebo; the endpoint will be evaluated. SECONDARY OUTCOME: Secondary end point(s): Decrease in on‐demand morphine consumption. Timepoint(s) of evaluation of this end point: After 4 days treatment of the patient we will evaluate this endpoint. INCLUSION CRITERIA: Age 18‐70 years. Patients are admitted to hospital Cancer pain judged to have a neuropathic component. Clinically normal renal and hepatic function. Patients are able to cooperate and understand information. ”Worst” pain at rest or on movement is 5 or more (NRS 0‐10). The pain is currently treated with continuous subcutaneous morphine infusion. The daily morphine dose is =48mg/24 hours and a 30% increase in the daily dose has not provided sufficient pain relief. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20