Treatment of neuropathic cancer pain.
Conditions
Interventions
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
Sponsors
Haukeland University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Reduced renal or hepatic function. Suspicion of morphine toxicity (sedation, hallucination, myoclonus, increasing pain). Increased intracranial pressure (suspicion of cerebral metastases) or cerebral metastases. Unable to cooperate/ understand information. ”Worst” pain at rest or on movement < 5 on NRS. Current treatment with other opioids than morphine. The patient is undergoing radiotherapy in the pain area, or has received radiotherapy in the pain area within the last four weeks. Changes in the use of analgesics (paracetamol, NSAIDS), adjuvant drugs (antidepressants, antiepileptics, corticosteroids, muscle relaxants) or their dosages less than 2 days prior to inclusion or during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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.;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Norway
Contacts
Public ContactPain Clinic
Haukeland University Hospital
Outcome results
None listed