Blood Levels of Ketamine in Patients Using Topical Application of 10% Ketamine Gel for Neuropathic Pain
|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: NCT01385904|
Recruitment Status : Unknown
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was: Recruiting
First Posted : June 30, 2011
Last Update Posted : June 30, 2011
The purpose of this research study is to measure how much, if any, ketamine is absorbed into the blood stream after ketamine gel is applied to the skin. The investigators expect that the topical administration will provide pain relief locally, at the site of pain, but not be absorbed into the bloodstream and thus not cause side effects. This research will help assess the safety of this drug by measuring the blood concentrations of the drug.
Ketamine is a general anesthetic drug but also has excellent pain relieving qualities. It has been used to relieve chronic pain by administering intravenously, by mouth, or as an injection beneath the skin. When given these ways ketamine can occasionally cause side effects like dizziness, nausea, nightmares, agitation, hallucinations. Recently it has been used topically for patients with neuropathic pain in order to avoid the dizziness and nausea side effects.
Neuropathic Pain can be partially caused by the misfiring of small nerve fibers close to the area of pain. By applying it on the skin, it is expected the drug can penetrate the skin and act directly on the small nerve fibers. The advantage is that less drug will get into the blood circulation. Up to now, it has not been carefully studied how much of the drug appears in the circulation after application on the skin.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Plasma Concentrations of Ketamine and Norketamine in Patients Using Topical Application of 10% Ketamine for Neuropathic Pain.|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
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): NCT01385904
|Contact: Patricia Morley-Forster, MD, FRCPC||(519) 646-6000 ext firstname.lastname@example.org|
|Contact: Rajarathinam Manikandan, MD||5196858500 ext email@example.com|
|Pain Clinic, St. Joseph's Health Care London Hospitals||Recruiting|
|London, Ontario, Canada, N6A 4V2|
|Contact: Patricia Morley - Forster, MD, FRCPC (519) 646-6000 ext 65065 firstname.lastname@example.org|
|Contact: Rajarathinam Manikandan, MD 5196858500 ext 13465 email@example.com|
|Principal Investigator: Patricia Morley- Forster, MD, FRCPC|
|Sub-Investigator: Rajarathinam Manikandan, MD|
|Sub-Investigator: Dr Craig Railton, MD FRCP(C)|
|Principal Investigator:||Patricia Morley- Forster, MD, FRCPC||University of Western Ontario, Canada|