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

This study is currently recruiting participants.
Verified June 2011 by Lawson Health Research Institute
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01385904
First received: June 29, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients attending the St Josephs Hospital pain clinic with chronic neuropathic pain.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385904

Contacts
Contact: Patricia Morley-Forster, MD, FRCPC (519) 646-6000 ext 65065 pat.morley-forster@sjhc.london.on.ca
Contact: Rajarathinam Manikandan, MD 5196858500 ext 13465 drmani.ab8@gmail.com

Locations
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     pat.morley-forster@sjhc.london.on.ca    
Contact: Rajarathinam Manikandan, MD     5196858500 ext 13465     drmani.ab8@gmail.com    
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
Investigators
Principal Investigator: Patricia Morley- Forster, MD, FRCPC University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: Dr. Patricia Morley-Forster, University of Western Ontario
ClinicalTrials.gov Identifier: NCT01385904     History of Changes
Other Study ID Numbers: R-11-137, 17756
Study First Received: June 29, 2011
Last Updated: June 29, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 23, 2013