A dose-escalation clinical trial of intranasal ketamine for uncontrolled cancer-related pain Restricted; Files Only
Singh, Vinita (Spring 2022)
Published
Abstract
Introduction
Intranasal (IN) ketamine has been shown to be effective in controlling breakthrough chronic pain. However, there are no data evaluating IN ketamine for cancer-related pain. The objective of our study was to determine safety and pharmacology (pharmacokinetics and preliminary efficacy) of IN ketamine for uncontrolled cancer-related pain
Methods
This was a clinical trial of 10 adult patients with uncontrolled cancer-related pain. Each patient received escalating doses of ketamine over four visits, each 2-5 days apart: 10 mg IN at visit 1, 10 mg intravenous (IV) at visit 2, 30 mg IN at visit 3, and 50 mg IN at visit 4. Pain was measured before and after drug administration for up to 4 hours using the 11-point (0-10) Numerical Pain Rating Scale (NPRS).
Results
All patients had advanced cancer, with intractable pain, despite being on moderate dosage of opioids. There was a significant reduction in median (interquartile range, p value) NPRS by 1.5 (1 – 4, p = 0.002), 3 (2 – 3, p = 0.002), and 4 (3 – 5, p = 0.008) points at 60 minutes after receiving the medication and remained decreased by 1.5 (1 – 2, p = 0.008), 2 (1 – 2, p = 0.008), and 1 (1 – 4, p = 0.008) points at the end of the study visit (240 minutes) with the 10-mg, 30-mg, and 50-mg IN ketamine dosage, respectively. The median (interquartile range) percentage of maximal pain relief was 22.5 (16.6 - 71.5), 65.5 (40 - 100), and 69.25 (50 - 100) for the 10-mg, 30-mg, and 50-mg IN dosage, respectively, and 100 (75 - 100) with 10-mg IV dose. All side effects (nausea and feeling of unreality) resolved by the end of each study visit. No severe adverse events occurred.
Conclusion
In this single-institution study, all dosages of IN ketamine administered in the study (10, 30, and 50 mg) provided significant pain relief for intractable cancer-related pain and were well tolerated. The 50-mg dose provided maximal pain relief without major side effects. Further study focused on repeated IN ketamine administration on efficacy and safety for cancer-related pain is warranted.
Table of Contents
INTRODUCTION…1 METHODS…3
RESULTS…9
DISCUSSION/CONCLUSIONS…13
REFERENCES…17
FIGURES…21
TABLES…27
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