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

NCT01207206 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-11-01

No results posted yet for this study

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

Interventions

DRUG

oral ketamine

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

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01207206 on ClinicalTrials.gov