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

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.

Intervention / Treatment

Condition or Disease

  • Neuropathic Pain.

Phase

Study Design

Study type: OBSERVATIONAL
Status: Unknown status
Study results: No Results Available
Age: 18 Years to 80 Years
Enrollment: 15 (ESTIMATED)
Funded by: Other
Time Perspective: Prospective
Observational Model: Case-Only

Masking

Clinical Trial Dates

Start date: Jun 01, 2011
Primary Completion: Dec 01, 2011 ESTIMATED
Completion Date: Dec 01, 2011 ESTIMATED
Study First Posted: Jun 30, 2011 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Jun 29, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: Yes

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)

More Details

NCT Number: NCT01385904
Other IDs: R-11-137
Study URL: https://clinicaltrials.gov/study/NCT01385904
Last updated: Sep 29, 2023