Recruiting

Ketamine

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT01385904

Conditions

Neuropathic Pain.

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Neuropathic Pain.

Study ID

NCT01385904

Start date

Jun, 2011

Status verified date

Jun, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Patricia Morley-Forster, MD, FRCPC

(519) 646-6000pat.morley-forster@sjhc.london.on.ca

Rajarathinam Manikandan, MD

5196858500drmani.ab8@gmail.com

Locations

Pain Clinic, St. Joseph's Health Care London Hospitals

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Patricia Morley - Forster, MD, FRCPC

(519) 646-6000pat.morley-forster@sjhc.london.on.ca

Rajarathinam Manikandan, MD

5196858500drmani.ab8@gmail.com

Principal Investigator:

Patricia Morley- Forster, MD, FRCPC

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jun 30, 2011

Last verified

Jun, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2011-06-30.