Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients
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ClinicalTrials.gov Identifier: NCT01207206
Verified September 2010 by Tel-Aviv Sourasky Medical Center. Recruitment status was: Recruiting
In the current research the investigators would like to examine the effect of a well acquainted drug, Ketamine, which is used by anesthesiologists to induce sleep in operations. Usually the ketamine is given into the vein and not orally. The investigators want to give it orally to cancer patients that sufffer from severe pain to find out whether it can prove their quality of life, lower their pain and reduce the amount of opioids they receive.
The group will be divided into two pain matched groups of 25 each. One group will receive Ketamine (K group) and the other placebo (P). Both the researchers and the patients will not know to which group they belong. Four days prior to the beginning of the research the patients will document, using an ad-hoc diary, in predetermined hours, four times a day the level (VAS) of pain, sedation and vomiting scores, and other side effects. Pain will be assessed using a Visual Analog Scale (VAS) (0-10).
The documentation will continue throughout the research period. The Ketamine or plaecebo will also be taken in a predetermined hours to avoid an effect of diurnal disruption on pain perception
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1. Patient suffering from severe cancer pain (VAS>6 at rest or on movement) despite the opioid treatment.
2. Opiate tolerance suspected on the basis of rapid escalation in opiate dose 3. Severe opiate side effects
1. Recent psychiatric hospitalization, suicide attempt, or history within the preceding month of electroconvulsive therapy 2. History of psychosis, eg, schizophrenia 3. History of recent seizures 4. Uncontrolled intracranial hypertension due to brain metastasis or hydrocephalus 5. Severe labile hypertension or poorly controlled cardiac arrhythmia 6. Chronic obstructive pulmonary disease (COPD) associated with hypercarbia