A Randomized Trial of NSAID Dosing Strategies

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Trial of NSAID Dosing Strategies

Conditions
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Musculoskeletal Pain, Acute Pain

Intervention / Treatment
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* Drug: NSAID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac<br>Ketorolac 20mg orally x 1 | Drug: NSAID<br>* We will administer oral NSAIDs<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen 800mg orally x 1 | Drug: NSAID<br>* We will administer oral NSAIDs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure to achieve a minimum clinically important difference | Failure to improve by at least 1.3 points on a 0-10 pain scale | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0-10 pain score | Improvement on 0-10 pain | One and two hours after medication administration | 
| Ordinal pain scale | The investigators will determine the frequency of obtaining pain levels of mild and none on a scale of severe, moderate', mild, or none | One and two hours after medication administration | 
| Epigastric pain | Participants will be asked if the medication caused stomach pain. Response options are no, a little, a lot | Two hours after medication administration |