Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04702555 |
| Other study ID # |
2020-10-17-MMC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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
Subjects: 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
Eligibility Criteria: Patients 18 years of age and older presenting to the ED with 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. Patients will have to be awake,
alert, and oriented to person, place, and time, and will be able to demonstrate understanding
of the informed consent process and content. Patients also will 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, and 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, or schizophrenia.
Design: This is a prospective observational pilot trail evaluating analgesic efficacy and
safety of VTS-K in adult patients presenting to the ED of Maimonides Medical Center with
acute musculoskeletal painful conditions. Upon meeting the eligibility criteria, patients
will be offered to participate in the study.
Data Collection Procedures: Each patient will be approached by a study investigator for
acquisition of written informed consent and Health Insurance Portability and Accountability
Act authorization after being evaluated by the treating emergency physician and determined to
meet study eligibility criteria. When English will not be the participant's primary language,
a language- appropriate consent form will be used and non-investigator, hospital-employed,
trained interpreters or licensed telephone interpreter will assist in acquisition of informed
consent. Baseline pain score will be determined with an 11-point numeric rating scale (0 to
10), described to the patient as "no pain" being 0 and "the worst pain imaginable" being 10.
A study investigator will record the patient's body weight and baseline vital signs.
The on-duty ED pharmacist will prepare an oral dose of ketamine by using a formulary for
parenteral use. The oral dosing regimen of ketamine is 0.5 mg/kg that will be placed in the
syringe or a medication cup. The research associate will deliver both medications
(VTS-Aspirin and Oral Ketamine) to the patient. Study investigators will record pain scores
and adverse effects at 15, 30, 60, and 90 minutes. If patients reported a pain numeric rating
scale score of 5 or greater and requested additional pain relief, an oral immediate release
morphine tablet of 7.5 mg will be given
All data will be recorded on data collection sheets, including patients' sex, demographics,
medical history, and vital signs, and entered into SPSS (version 24.0; IBM Corp) by the
research manager. Confirmation of written consent acquisition for all participants, and
statistical analyses will be conducted by the statistician, who will work independently of
any data collection.
Patients will be closely monitored for adverse effects during the entire study period (up to
90 minutes) by study investigators. Common adverse effects that are associated with oral
ketamine are felling of unreality, dizziness, nausea, vomiting, and sedation. Common adverse
effects are associated with VTS-Aspirin are nausea, dyspepsia, epigastric discomfort.
