Pain, Intractable Clinical Trial
— KETA-1Official title:
Low-dose Ketamine as Adjuvant Treatment to Morphine in Neuropathic Cancer Pain
Verified date | July 2017 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with neuropathic cancer pain.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: Age 18-70 years. In-patient. Cancer pain judged to have a neuropathic component. Clinically normal renal and hepatic function. Able to cooperate and understand information. Worst pain at rest or on movement 5 or more (NRS 0-10). Pain currently treated with continuous subcutaneous morphine infusion. The daily morphine dose is 48mg or more per 24 hours and a 30% increase in the daily dose has not provided sufficient pain relief. Not treated with ketamine during the last 48 hours prior to inclusion. 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 less than 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, antiepileptic, corticosteroids, muscle relaxants) or their dosages less than 2 days prior to inclusion or during the study period. Pregnant and lactating women. Any situation in which an increase in blood pressure would constitute a hazard. Acute intermittent porphyria. Psychiatric illness, epilepsy, alcoholism, glaucoma. Hypersensitivity to any of the drugs ingredients. Current treatment with ketamine. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | Hordaland |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain intensity compared to baseline. | Significant reduction in cancer pain intensity will be defined as at least 30% reduction in Numeric Rating Scale (NRS) score compared to baseline. | 5 days |
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