A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Condition: Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute Pain is one of the most frequent chief complaints and the main reason for visiting the
      Emergency Department (ED). The acute pain in the ED is largely prevalent across the country
      with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a
      variety of acute painful syndromes. There is a lack of good options for pain control in such
      settings.
    

Detailed description: 
      STUDY OBJECTIVES: To compare analgesic efficacy and rates of side effects of a proprietary
      formulation of orally administered aspirin and ketamine (AOK) to a proprietary formulation of
      Oral Ketamine (OK) (VTS-K formulations) for pain management in adult ED patients presenting
      to the ED with acute musculoskeletal pain HYPOTHESIS: The investigators hypothesize that the
      administration of AOK will provide better analgesia at 60 minutes post-administration in
      comparison to OK in adult patients presenting to the ED with acute musculoskeletal pain. The
      primary outcome of this trial is the comparative 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 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.

      Design: This is a prospective, randomized, open-label trial comparing analgesic efficacy and
      safety of AOK and OK in patients presenting to the ED of Maimonides Medical Center with acute
      musculoskeletal pain. Upon meeting the eligibility criteria, patients will be randomized into
      one of the two study arms: Group I will receive AOK and Group II will receive OK.

      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 interpreters 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. 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.

      Expected Outcomes: The primary outcome will include a reduction from baseline of pain scores
      on numeric rating pain scale (NRS) at 60 minutes. The secondary outcomes will include a need
      for rescue analgesia and rates of adverse up to 120 minutes. With respect to unique adverse
      effects of SDK, we will use Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)
      and Richmond Agitation Sedation Scale (RASS). SERSDA Scale includes fatigue, dizziness,
      nausea, headache, feeling of unreality, changes in hearing, mood change, general discomfort,
      and hallucinations with severity of each graded by patients on a five-point scale, with "0"
      representing the absence of any adverse effects and "4" representing a severely bothersome
      side effect. RASS evaluates the severity of agitation and/or sedation in accordance to the
      nine-point scale with scores ranging from "-4" (deeply sedated) to "0" (alert and calm) to
      "+4" (combative).
    

Intervention name(s): Aspirin and Ketamine; Oral Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin; Proprietary oral formulation of 0.5mg/kg of ketamine
Intervention MeSH terms: Aspirin; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emergency Medicine, Pain, Pain Management, Musculoskeletal; Emergency Medicine; Pain; Pain Management; Musculoskeletal