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Ketamine Clinical Trials

Analgesic Efficacy of Orally Administered VTS-K (Liquid Oral Ketamine Taken Simultaneously With VTS-Aspirin) for Pain Management of Adult ED Patients Presenting to the ED With Acute Musculoskeletal Pain

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Id: NCT04702555

Organisation Name: Maimonides Medical Center

Overal Status: Completed

Start Date: January 8, 2021

Last Update: April 8, 2022

Lead Sponsor: Antonios Likourezos

Brief Summary: A combination of ketamine and aspirin for the treatment of acute MSK pain in the ED would confer multimodal analgesia, with the contributions of aspirin and ketamine to an opioid sparing effect. Research on this multimodal approach is sparse, but the minimal empirical evidence supports a clinical benefit to patients in a post orthopedic surgery setting, both in short term and long term.

Vitalis Pharmaceuticals (New York, NY) has developed a proprietary formulation of aspirin, VTS-Aspirin, that may deliver faster and stronger pain reduction than traditional aspirin. Preliminary research indicates that combinations of VTS-Aspirin with analgesics may confer greater benefit in pain management than some current standards of care (26).

An oral combination drug of VTS-Aspirin and ketamine (VTS-K) would facilitate the shift from IV opioids to a non-IV therapy for patients presenting to the ED with acute MSK pain. This formulation has a potential to provide effective analgesia in the ED with reduced side effects. VTS-K's proprietary oral formulation of established, safe, and well-understood APIs, makes it uniquely appropriate for use in the ED. VTS-K is administered orally, which is suitable for resource-poor environments in which the healthcare setting may be inadequate as well as suitable to improve the throughput of ED Patients by reducing their length of stay. This is especially pertinent given the alternative of IV opioids for pain management of acute MSK pain, which requires both clinical monitoring and equipment, whereas VTS-K promotes weaning off opioids, alleviating the resource consumption.

  • Pain, Acute

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