Blood Levels of Ketamine in Patients Using Topical Application of 10% Ketamine Gel for Neuropathic Pain
NCT ID: NCT01385904
Last Updated: 2011-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2011-06-30
2011-12-31
Brief Summary
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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
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Duration of pain more than 3 months.
* Ability to speak English adequately to consent to and participate in the study
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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University of Western Ontario
Principal Investigators
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Patricia Morley- Forster, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
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Pain Clinic, St. Joseph's Health Care London Hospitals
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Patricia Morley - Forster, MD, FRCPC
Role: primary
Rajarathinam Manikandan, MD
Role: backup
References
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Poyhia R, Vainio A. Topically administered ketamine reduces capsaicin-evoked mechanical hyperalgesia. Clin J Pain. 2006 Jan;22(1):32-6. doi: 10.1097/01.ajp.0000149800.39240.95.
Finch PM, Knudsen L, Drummond PD. Reduction of allodynia in patients with complex regional pain syndrome: A double-blind placebo-controlled trial of topical ketamine. Pain. 2009 Nov;146(1-2):18-25. doi: 10.1016/j.pain.2009.05.017. Epub 2009 Aug 22.
Zapantis G, Csoka I, Csanyi E, Horvath G, Eros I. Evaluation of ketamine systemic absorption from topical preparations. Short Communication. Acta Biol Hung. 2006 Sep;57(3):387-9. doi: 10.1556/ABiol.57.2006.3.12.
Clements JA, Nimmo WS, Grant IS. Bioavailability, pharmacokinetics, and analgesic activity of ketamine in humans. J Pharm Sci. 1982 May;71(5):539-42. doi: 10.1002/jps.2600710516.
Pedersen JL, Galle TS, Kehlet H. Peripheral analgesic effects of ketamine in acute inflammatory pain. Anesthesiology. 1998 Jul;89(1):58-66. doi: 10.1097/00000542-199807000-00011.
Lynch ME, Clark AJ, Sawynok J, Sullivan MJ. Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jul;103(1):140-6. doi: 10.1097/00000542-200507000-00021.
Grant IS, Nimmo WS, Clements JA. Pharmacokinetics and analgesic effects of i.m. and oral ketamine. Br J Anaesth. 1981 Aug;53(8):805-10. doi: 10.1093/bja/53.8.805.
Other Identifiers
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17756
Identifier Type: OTHER
Identifier Source: secondary_id
R-11-137
Identifier Type: -
Identifier Source: org_study_id