Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01207206|
Recruitment Status : Unknown
Verified September 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Recruiting
First Posted : September 22, 2010
Last Update Posted : November 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain Tolerance||Drug: oral ketamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2012|
- 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
- The capability of oral ketamine treatment to reduce pain [ Time Frame: 4 months ]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.
- evaluation of side effects related to ketamine in cancer pain patients [ Time Frame: 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207206
|Contact: Silviu Brill, MDfirstname.lastname@example.org|
|Tel Aviv Sourasky Medical Center, Pain Medicine Unit||Recruiting|
|Tel Aviv, Israel|
|Contact: silviu Brill, M.D 972-3-6974477 email@example.com|
|Principal Investigator: Silviu Brill, M.D|