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Blood Levels of Ketamine in Patients Using Topical Application of 10% Ketamine Gel for Neuropathic Pain

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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
Sponsor:
Information provided by:
Lawson Health Research Institute

Tracking Information
First Submitted Date June 29, 2011
First Posted Date June 30, 2011
Last Update Posted Date June 30, 2011
Study Start Date June 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Levels of Ketamine in Patients Using Topical Application of 10% Ketamine Gel for Neuropathic Pain
Official Title Plasma Concentrations of Ketamine and Norketamine in Patients Using Topical Application of 10% Ketamine for Neuropathic Pain.
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients attending the St Josephs Hospital pain clinic with chronic neuropathic pain.
Condition Neuropathic Pain.
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†29,¬†2011)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with peripheral, focal neuropathic pain such as or complex regional pain syndrome following surgery, bony, soft tissue trauma or nerve trauma, associated with significant allodynia and hyperalgesia who score equal to or greater than 4 in the DN4 questionnaire.
  • Duration of pain more than 3 months.
  • Ability to speak English adequately to consent to and participate in the study

Exclusion Criteria:

  • Allergy to ketamine
  • Severe medical illnesses like, e.g. unstable angina, tachyarryhthmias, renal or hepatic failure
  • History of psychosis.
  • Patients who are already on oral ketamine treatment.
  • Patients who are taking HIV Antiretrovirals: (indinavir, nelfinavir, ritonavir saquinavir); Antibiotics: (clairithromycin, itraconazole, ketoconazole, telithromycin,fluconazole, erythromycin); Calcium Channel Blockers (verapamil, diltiazem),Amiodarone, Ciprofloxacin. (These drugs inhibit CYP 3A4 enzyme which metabolises ketamine)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01385904
Other Study ID Numbers R-11-137
17756 ( Other Identifier: REB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Patricia Morley-Forster, University of Western Ontario
Study Sponsor Lawson Health Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Patricia Morley- Forster, MD, FRCPC University of Western Ontario, Canada
PRS Account Lawson Health Research Institute
Verification Date June 2011