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
Brief Title
A Randomized Trial of NSAID Dosing Strategies
Categories
Completion Date
Completion Date Type
Actual
Conditions
Musculoskeletal Pain
Acute 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:
* 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
69 Years
Minimum Age
18 Years
NCT Id
NCT05239767
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2022-13802
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Trial of NSAID Dosing Strategies
Primary Outcomes
Outcome Description
Failure to improve by at least 1.3 points on a 0-10 pain scale
Outcome Measure
Failure to achieve a minimum clinically important difference
Outcome Time Frame
Two hours
Secondary Outcomes
Outcome Description
Improvement on 0-10 pain
Outcome Time Frame
One and two hours after medication administration
Outcome Measure
0-10 pain score
Outcome Description
The investigators will determine the frequency of obtaining pain levels of "mild" and "none" on a scale of "severe", "moderate', "mild", or "none"
Outcome Time Frame
One and two hours after medication administration
Outcome Measure
Ordinal pain scale
Outcome Description
Participants will be asked if the medication caused "stomach pain". Response options are "no", "a little", "a lot"
Outcome Time Frame
Two hours after medication administration
Outcome Measure
Epigastric pain
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
69
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415