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

NCT ID: NCT04860804

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2021-12-31

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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AOK Group

Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin

Group Type: ACTIVE_COMPARATOR

Aspirin and Ketamine

Intervention Type: DRUG

Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin

OK Group

Drug: Proprietary oral formulation of 0.5mg/kg of ketamine

Group Type: ACTIVE_COMPARATOR

Oral Ketamine

Intervention Type: DRUG

Proprietary oral formulation of 0.5mg/kg of ketamine

Interventions

Aspirin and Ketamine

Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin

Intervention Type: DRUG

Oral Ketamine

Proprietary oral formulation of 0.5mg/kg of ketamine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonios Likourezos

OTHER

Sponsor Role: lead

Responsible Party

Antonios Likourezos

Research Administration Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leily Naraghi Bagher Pour, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

References

Gerges L, Fassassi C, Barberan C, Correa Bravo S, Davis A, Drapkin J, Likourezos A, Silver M, Hossain R, Niceforo P, Gohel A, Motov S. Oral Aspirin/ketamine versus oral ketamine for emergency department patients with acute musculoskeletal pain. Am J Emerg Med. 2022 Aug;58:298-304. doi: 10.1016/j.ajem.2022.05.026. Epub 2022 May 19.

Reference Type: DERIVED

PMID: 35777275 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-02-02-MMC

Identifier Type: -

Identifier Source: org_study_id