JMIR Publications

ABSTRACT

Background:

There are about 11.9 million Americans affected with cancer; of these, 53% of patients with cancer experience pain at all stages of cancer. Patients with cancer pain often require high dosages of opioids that can cause significant sedation. Occasionally, even after high dose opioid therapy, their pain remains uncontrolled in the setting of opioid tolerance or opioid unresponsive pain. Ketamine is an FDA approved anesthetic with amnesic, analgesic, dissociative, and sedative properties. Subanesthestic doses of ketamine have minimal adverse impact upon cardiovascular or respiratory function, but produce analgesia and modulate central sensitization, hyperalgesia, and opioid tolerance. Ketamine is typically administered intravenously (IV), but the IV route is not convenient for use in an ambulatory setting. Ketamine oral bioavailability is low due to hepatic first pass effect, limiting the application of this route for chronic use. The intranasal (NAS) route has several advantages, such as avoidance of first-pass hepatic metabolism, no need for venous access, ability to repeat doses quickly, and rapid absorption. There are limited data regarding the use of ketamine as an adjuvant to opioids for the management of cancer pain.

Objective:

We seek to obtain preliminary data on safety, feasibility, and utility of this novel technique for the treatment of uncontrolled cancer pain.

Methods:

A total of 10 adults with uncontrolled cancer related pain from the supportive oncology clinic, oncology clinics, the pain clinic, and the acute pain service at Emory University Hospital in Atlanta, GA will be enrolled in the study. All patients will be assigned to the same and only investigational treatment arm. Escalating doses of NAS ketamine will be given over 4 study visits (10mg, 30mg, 50mg). Patients will receive 10mg IV ketamine on visit 2 to serve as a control. They will be monitored for 240min after treatment. Pain, side effects, and related symptoms will be assessed using standardized assessment scales throughout each visit. Pharmacokinetics will be determined by drawing serial blood samples at each visit.

Results:

This trial has been funded by the Emory University Department of Anesthesiology, and is supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number ULTR002378 and KL2TR002381. IND receipt obtained 12/21/16 (IND133570). Approval by the Emory University institutional review board obtained 4/2/2017 (IRB 00086610). The study start date is 7/25/17 and estimated completion date is 7/1/19. Recruitment started in July 2017.

Conclusions:

This is a Phase I/II clinical trial meant to obtain preliminary data on the safety, feasibility, and utility of intranasal ketamine for the treatment of uncontrolled cancer related pain. Clinical Trial: ClinicalTrials.gov ID: NCT03146806