Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients|
- The capability of oral ketamine treatment to reduce pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|