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. 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
Information provided by:
Lawson Health Research Institute

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.

Condition or disease
Neuropathic Pain.

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients attending the St Josephs Hospital pain clinic with chronic neuropathic pain.

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01385904

Contact: Patricia Morley-Forster, MD, FRCPC (519) 646-6000 ext 65065
Contact: Rajarathinam Manikandan, MD 5196858500 ext 13465

Canada, Ontario
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   
Contact: Rajarathinam Manikandan, MD    5196858500 ext 13465   
Principal Investigator: Patricia Morley- Forster, MD, FRCPC         
Sub-Investigator: Rajarathinam Manikandan, MD         
Sub-Investigator: Dr Craig Railton, MD FRCP(C)         
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Patricia Morley- Forster, MD, FRCPC University of Western Ontario, Canada

Responsible Party: Dr. Patricia Morley-Forster, University of Western Ontario Identifier: NCT01385904     History of Changes
Other Study ID Numbers: R-11-137
17756 ( Other Identifier: REB )
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action