Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients

NCT01207206 | Unknown

• 1 other identifier: TASMC-10-SB-392-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Pain; Tolerance

Keywords

Patient suffering from severe cancer pain despite the opioid treatment; Opiate tolerance suspected on the basis of rapid escalation in opiate dose; Severe opiate side effects

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• evaluation of side effects related to ketamine in cancer pain patients

  4 months

Interventions

oral ketamine DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient suffering from severe cancer pain (VAS\>6 at rest or on movement) despite the opioid treatment.
• \. Opiate tolerance suspected on the basis of rapid escalation in opiate dose 3. Severe opiate side effects

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Silviu Brill, MD

CONTACT

972-3-6974477; silviub@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 1, 2011

Record last verified: 2010-09

Locations

IL (1)