A Randomized Trial of NSAID Dosing Strategies
- Registration Number
- NCT05239767
- Lead Sponsor
- Montefiore Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
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
- 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)
- Contraindication to acetaminophen (hepatitis or cirrhosis)
- Use of an NSAID within the previous eight hours
- Use of acetaminophen within the previous eight hours
- Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
- Recurrent pain in the same body part as the presenting complaint
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Ketorolac NSAID Ketorolac 20mg orally x 1 Ibuprofen NSAID Ibuprofen 800mg orally x 1
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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"
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"
Trial Locations
- Locations (1)
Montefiore
🇺🇸Bronx, New York, United States