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.
PainRelief.com Interview with: Shannon Lovett, MD, FACEP Associate Professor Associate Medical Director, ED Clinical Operations Department of Emergency Medicine Stritch School of Medicine
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.
Jefferson DrapkinBS Research Associate Maimonides Medical Center Department of Emergency Medicine Brooklyn, New York
PainRelief.com: What is the
background for this study? What are the
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.
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