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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
STUDY OBJECTIVES
To evaluate 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
HYPOTHESIS
In our pilot study we hypothesize that the VTS-K combination will result in analgesia with a change in pain score at least of 1.3 points on NRS. The primary outcome of this trial is the reduction in participant's pain scores at 60 minutes post medication administration.
STUDY DESIGN
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: VTS-K (Drug)
结局指标
主要结局
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
时间窗: 30 minutes
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.
次要结局
未报告次要终点
研究者
Antonios Likourezos
Research Manager
Maimonides Medical Center