NCT04860804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 7, 2023

Completed
Last Updated

July 17, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

April 22, 2021

Results QC Date

March 15, 2023

Last Update Submit

June 20, 2024

Conditions

Pain

Keywords

Emergency Medicine, Pain, Pain Management, MusculoskeletalEmergency MedicinePainPain ManagementMusculoskeletal

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Score at 60 Minutes

    Change 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.

    60 minutes

Study Arms (2)

AOK Group

ACTIVE COMPARATOR

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

Drug: Aspirin and Ketamine

OK Group

ACTIVE COMPARATOR

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

Drug: Oral Ketamine

Interventions

Aspirin and KetamineDRUG

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

AOK Group
Oral KetamineDRUG

Proprietary oral formulation of 0.5mg/kg of ketamine

OK Group

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

  • 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.

    PMID: 35777275DERIVED

MeSH Terms

Conditions

PainAgnosia

Interventions

AspirinKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, Alicyclic

Results Point of Contact

Title
Dr. Sergey Motov
Organization
Maimonides Medical Center
smotov@maimonidesmed.org
718-283-8693

Study Officials

  • Leily Naraghi Bagher Pour, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Administration Director

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

April 22, 2021

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

July 17, 2024

Results First Posted

April 7, 2023

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)