Study Finds False or Misleading Claims Not Uncommon Among Ketamine Prescribers

PainRelief.com Interview with:
Michael J. DiStefano, PhD

Department of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences
University of Colorado Anschutz Medical Campus, Aurora

PainRelief.com: What is the background for this study? What is ketamine primarily used for?

Response: Ketamine has been an FDA-approved anesthetic since 1970. However, it is increasingly used off-label to treat a variety of mental health and pain conditions. Some providers also offer oral formulations of ketamine, which do not have FDA approval for any indication. Esketamine, an enantiomer of ketamine, is a nasal spray that recently received FDA approval and is narrowly indicated for people with treatment-resistant depression. Esketamine has an extensive FDA REMS (Risk Evaluation and Mitigation Strategies) protocol in place to promote safe use. There is no analogous safety protocol in place for the off-label or unapproved use of ketamine.

Given increasing interest in using ketamine to treat a variety of conditions, we were interested to see how the drug is being promoted to potential patients. The FDA typically regulates consumer advertising for prescription drugs, but only for manufacturers, packers, and distributors of these drugs, designations which don’t seem to include these clinics. The FDA requires that consumer drugs ads are accurate and provide balanced information on both benefits and risks.

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Lower Ketamine Dose Can Provide Pain Relief for Acute Pain in ER

PainRelief.com Interview with:
Shannon Lovett, MD, FACEP
Associate Professor
Associate Medical Director, ED Clinical Operations
Department of Emergency Medicine
Stritch School of Medicine

Dr. Lovett

PainRelief.com:  What is the background for this study?  What types of pain were treated?

Response: The opioid crisis has led emergency medicine providers to utilize other medications to treat pain, including ketamine. Prior to our study, there was a range of recommended ketamine doses in the treatment of pain, and the most frequently studied dose demonstrating analgesic efficacy was 0.3 mg/kg. We challenged that dose by comparing a lower dose, 0.15 mg/kg, to 0.3 mg/kg of IV ketamine for acute moderate to severe pain in the emergency department. We treated acute (onset < 7 days) abdominal, back, flank, musculoskeletal, and headache pain. 

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Nebulized Ketamine May Offer Pain Relief to Emergency Room Patients

PainRelief.com Interview with:

Jefferson Drapkin BS
Research Associate
Maimonides Medical Center
Department of Emergency Medicine
Brooklyn, New York

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Nebulized administration of ketamine has been studied in the areas of palliative care, therapy for asthma, and acute postoperative management of sore throat. To our knowledge, there is no literature regarding analgesic efficacy and safety of nebulized ketamine’s role in managing acute painful conditions in the emergency department (ED).

As all five patients had a decrease in pain from baseline to 120 min, this case series demonstrates that the inhalation route of ketamine delivery via breath-actuated nebulizer may have utility for managing pain in the ED.