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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
Information provided by:
Lawson Health Research Institute Identifier:
First received: June 29, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

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.

Neuropathic Pain.

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Estimated Enrollment: 15
Study Start Date: June 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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 )
Study First Received: June 29, 2011
Last Updated: June 29, 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 processed this record on September 21, 2017