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Trial record 39 of 666 for:    OXYCODONE

APAP +/- Oxycodone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04122443
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : October 16, 2019
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Brief Summary:
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Drug: Acetaminophen Drug: Oxycodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acetaminophen
Acetaminophen alone
Drug: Acetaminophen
Acetaminophen 650mg

Active Comparator: Oxycodone/ acetaminophen
Oxycodone + acetaminophen
Drug: Acetaminophen
Acetaminophen 650mg

Drug: Oxycodone
Oxycodone 10mg

Primary Outcome Measures :
  1. Pain assessment with numeric rating scale (NRS). [ Time Frame: 2 hours ]
    The Numeric Rating Scale (NRS) for evaluating pain. The rating is verbal, and the subject is asked to estimate current pain intensity on an 11-point scale, where 0 indicates no pain at all and 10 the worst imaginable pain.

  2. Pain assessment with four-item ordinal scale [ Time Frame: 2 hours ]
    The rating is verbal and the subject is asked to describe their pain using descriptors (1)severe, (2)moderate, (3)mild or (4)none

Secondary Outcome Measures :
  1. Adequacy of analgesia [ Time Frame: 2 hours ]
    This is a single question: Did the medication we gave you control your pain? Answer choices: Yes (it did); No (It did not); and Not sure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
  • Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria:

  • Use of an non-steroidal anti-inflammatory drug within the previous six hours
  • Use of acetaminophen within the previous six hours
  • Use of an opioid within the previous ten days
  • Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
  • Gout

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04122443

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Contact: Benjamin W Friedman 718-920-6626

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United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Benjamin W Friedman, MD    718-920-6626   
Sponsors and Collaborators
Montefiore Medical Center

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Responsible Party: Benjamin W. Friedman, MD, Principal Investigator, Montefiore Medical Center Identifier: NCT04122443     History of Changes
Other Study ID Numbers: 2019-10592
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Analgesics, Opioid
Central Nervous System Depressants