Back to resultsAPAP +/- Oxycodone
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
Eligibility Criteria
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
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Acetaminophen
Oxycodone/ acetaminophen
Arm Description
Acetaminophen alone
Oxycodone + acetaminophen
Outcomes
Primary Outcome Measures
Pain assessment with numeric rating scale (NRS).
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.
Pain assessment with four-item ordinal scale
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
Adequacy of analgesia
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
Full Information
NCT ID
NCT04122443
First Posted
October 8, 2019
Last Updated
August 3, 2022
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04122443
Brief Title
APAP +/- Oxycodone
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen alone
Arm Title
Oxycodone/ acetaminophen
Arm Type
Active Comparator
Arm Description
Oxycodone + acetaminophen
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen 650mg
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Oxycodone 10mg
Primary Outcome Measure Information:
Title
Pain assessment with numeric rating scale (NRS).
Description
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.
Time Frame
2 hours
Title
Pain assessment with four-item ordinal scale
Description
The rating is verbal and the subject is asked to describe their pain using descriptors (1)severe, (2)moderate, (3)mild or (4)none
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Adequacy of analgesia
Description
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
Time Frame
2 hours
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
APAP +/- Oxycodone
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