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

NCT01385904 | Unknown

• 2 other identifiers: R-11-13717756
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

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

London, Ontario, N6A 4V2, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 16340591 BACKGROUND

• 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.

  PMID: 19703730 BACKGROUND

• 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.

  PMID: 17048702 BACKGROUND

• 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.

  PMID: 7097501 BACKGROUND

• 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.

  PMID: 9667294 BACKGROUND

• 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.

  PMID: 15983466 BACKGROUND

• 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.

  PMID: 7272143 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Morley- Forster, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Morley-Forster, MD, FRCPC

CONTACT

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

Rajarathinam Manikandan, MD

CONTACT

5196858500; drmani.ab8@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 30, 2011

Record last verified: 2011-06

Locations

CA (1)