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Author Notes:

Vinita Singh, Emory University Hospital Midtown, 550 Peachtree Street NE, Atlanta, GA 30308, USA., vinita.singh@emory.edu

We would like to thank the Department of Anesthesiology at Emory University School of Medicine for support. Ms. Ashley Holloman assisted in the conduct of this clinical trial in her role as a research coordinator.

Singh—Scientific advisor, Releviate LLC. All other authors declare no conflicts of interest.

Subjects:

Research Funding:

Vinita Singh was a KL2 scholar at the Georgia, Clinical and Translational Science Alliance and would like to acknowledge that this manuscript was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award number ULTR002378 and KL2TR002381. Supplemental funds to conduct this clinical trial were provided by the Team Based Science award via the Department of Anesthesiology, Emory University. Maya Tsvetkova and Jan Beumer helped with analysis of pharmacokinetic parameters and their work was supported in part by award P30CA47904. Jeffery Switchenko’s support was funded by P30CA138292. The content is solely the responsibility of the authors and does not necessarily represent the official view of the National Institutes of Health.

Keywords:

  • cancer pain
  • intranasal ketamine
  • pharmacodynamics
  • pharmacokinetics
  • safety

A dose-escalation clinical trial of intranasal ketamine for uncontrolled cancer-related pain

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Journal Title:

PHARMACOTHERAPY

Volume:

Volume 42, Number 4

Publisher:

, Pages 298-310

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Study Objective: The objective of our study was to determine safety and pharmacology (pharmacokinetics and preliminary efficacy) of intranasal (IN) ketamine for uncontrolled cancer-related pain. Design: Dose escalation clinical trial. Setting: Outpatient. Patients: Ten adult patients with uncontrolled cancer-related pain. Intervention: 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. Measurements: Pain was measured before and after drug administration for up to 4 h using the 11 point (0–10) Numerical Pain Rating Scale (NPRS). Main Results: All subjects had advanced cancer, with intractable pain, despite being on moderate dosage of opioids. There was a statistically significant reduction in median NPRS by 1.5 (1–4), 3 (2–3), and 4 (3–5) points at 60 min after receiving the medication and remained decreased by 1.5 (1–2), 2 (1–2) and 1 (1–4) points at the end of the study visit (240 min) with the 10 mg, 30 mg and 50 mg IN dosage, respectively. The median percentage of maximal pain relief being 22.5 (16.6–71.5), 65.5 (40–100), and 69.25 (50–100) for 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 administration efficacy and safety for cancer-related pain is warranted.
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