Analgesic Efficacy of Orally Administered VTS-K for Pain Management
Sponsored by Antonios Likourezos
About This Study
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.
Conditions Studied
Interventions
- •VTS-K
Eligibility
View full eligibility criteria
Inclusion Criteria: * 18 years+ * presenting to Maimonides Medical Center ED * acute musculoskeletal painful conditions (traumatic and non-traumatic) with an initial pain score of 5 on a standard 11- point (0 to 10) numeric rating scale * be awake, alert, and oriented to person, place, and time, * demonstrate understanding of the informed consent process and content. * have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS. Exclusion Criteria: * Patients with altered mental status * allergy to aspirin and ketamine * pregnant patients * unstable vital signs (systolic blood pressure \<90 or\>180 mm Hg * pulse rate \<50 or \>150 beats/min * respiration rate \<10 or \>30 breaths/min) * inability to provide consent * consumption of Aspirin or NSAID's within 6 hours of arrival to the ED * active PUD * history of GI Hemorrhage * history of renal and hepatic insufficiency * past medical history of alcohol or drug abuse * schizophrenia.