Analgesic Efficacy of Orally Administered VTS-K for Pain Management

NCT04702555 | Completed FDA Drug

• 1 other identifier: 2020-10-17-MMC
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

Pain; Pain Management; Ketamine; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• The analgesic efficacy of orally administered VTS-K (liquid oral ketamine taken simultaneously with VTS-Aspirin and oral ketamine (in a liquid form)) for pain management of adult ED patients presenting to the ED with acute musculoskeletal pain

  To assess whether VTS-K is effective in reducing acute MSK pain in ED patients using a 11 Point Likert Scale with 0 being no pain, 5 being moderate pain, and 10 being severe pain.

  30 minutes

Study Arms (1)

Vitalis Pharmaceuticals (VTS)-Aspirin and Ketamine

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.

Drug: VTS-K

Interventions

VTS-K DRUG

An oral combination drug of VTS-Aspirin and ketamine (VTS-K)

Vitalis Pharmaceuticals (VTS)-Aspirin and Ketamine

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age and older presenting to the ED with acute musculoskeletal painful conditions (traumatic and non-traumatic) with a an initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale and requiring oral analgesia as determined by the treating attending physician. Patients' screening and enrollment will be performed by study investigators and research assistants. All patients will be enrolled at various times of the day when study investigators will be available for patient enrollment and an ED pharmacist will be available for medication preparation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

• Davis A, Fassassi C, Dove D, Drapkin J, Likourezos A, Gohel A, Favale P, Hossain R, Butt M, Gerges L, Motov S. Analgesic Efficacy of Oral Aspirin/Ketamine Combination for Management of Acute Musculoskeletal Pain in the Emergency Department - A Proof of Concept Pilot Study. J Emerg Med. 2022 Jun;62(6):750-759. doi: 10.1016/j.jemermed.2022.01.029. Epub 2022 May 24.

  PMID: 35624056 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: January 8, 2021
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)