Pain Clinical Trial
Official title:
Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Tel Aviv Sourasky Medical Center, Pain Medicine Unit | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The capability of oral ketamine treatment to reduce pain | The study is a prospective randomized, placebo-controlled double -blind study involving. Subjects Fifty patients with unbalanced (VAS>6) chronic cancer-related pain despite opioid treatment. | 4 months | No |
Secondary | evaluation of side effects related to ketamine in cancer pain patients | The study is a prospective randomized, placebo-controlled double -blind study involving. Subjects Fifty patients with unbalanced (VAS>6) chronic cancer-related pain despite opioid treatment. | 4 months | No |
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