A Randomized Trial of NSAID Dosing Strategies
Study Details
Study Description
Brief Summary
This study will compare the efficacy of two different non-steroidal anti-inflammatory drugs (NSAIDs) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal pain. The investigators will also determine whether taking acetaminophen prior to the NSAID impacts efficacy
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Ketorolac Ketorolac 20mg orally x 1 |
Drug: NSAID
We will administer oral NSAIDs
|
Active Comparator: Ibuprofen Ibuprofen 800mg orally x 1 |
Drug: NSAID
We will administer oral NSAIDs
|
Outcome Measures
Primary Outcome Measures
- Failure to achieve a minimum clinically important difference [Two hours]
Failure to improve by at least 1.3 points on a 0-10 pain scale
Secondary Outcome Measures
- 0-10 pain score [One and two hours after medication administration]
Improvement on 0-10 pain
- Ordinal pain scale [One and two hours after medication administration]
The investigators will determine the frequency of obtaining pain levels of "mild" and "none" on a scale of "severe", "moderate', "mild", or "none"
- Epigastric pain [Two hours after medication administration]
Participants will be asked if the medication caused "stomach pain". Response options are "no", "a little", "a lot"
Eligibility Criteria
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
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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:
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Contraindication to NSAIDs (allergy to NSAID or allergy to aspirin without history of tolerating NSAIDs, history of gastrointestinal bleeding, daily medication for gastritis or PUD, chronic kidney disease 2-5, heart failure)
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Contraindication to acetaminophen (hepatitis or cirrhosis)
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Use of an NSAID within the previous eight hours
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Use of acetaminophen within the previous eight hours
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Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
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Recurrent pain in the same body part as the presenting complaint
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Montefiore | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Benjamin W Friedman, MD, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-13802