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A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT04860804
Recruitment Status : Completed
First Posted : April 27, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE April 27, 2021
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE April 22, 2021
Actual Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
Reduction in Pain score at 60 minutes [ Time Frame: 60 minutes ]
Reduction of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Official Title  ICMJE A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone in Adult Patients Presenting to the ED With Acute Musculoskeletal Pain: Prospective, Randomized, Open-Label, Clinical Trial.
Brief 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Aspirin and Ketamine
    Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
  • Drug: Oral Ketamine
    Proprietary oral formulation of 0.5mg/kg of ketamine
Study Arms  ICMJE
  • Active Comparator: AOK Group
    Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
    Intervention: Drug: Aspirin and Ketamine
  • Active Comparator: OK Group
    Drug: Proprietary oral formulation of 0.5mg/kg of ketamine
    Intervention: Drug: Oral Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients age 18 and older
  • acute musculoskeletal pain
  • initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
  • awake, alert, and oriented to person, place, and time

Exclusion Criteria:

  • altered mental status,
  • allergy to aspirin and ketamine,
  • pregnant
  • 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
  • schizophrenia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04860804
Other Study ID Numbers  ICMJE 2021-02-02-MMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Antonios Likourezos, Maimonides Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Antonios Likourezos
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leily Naraghi Bagher Pour, MD Maimonides Medical Center
PRS Account Maimonides Medical Center
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP