Status:

COMPLETED

A Randomized Trial of NSAID Dosing Strategies

Lead Sponsor:

Montefiore Medical Center

Conditions:

Musculoskeletal Pain

Acute Pain

Eligibility:

All Genders

18-69 years

Phase:

PHASE4

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 investig...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 24 2023

Estimated Enrollment :

407 Patients enrolled

Trial Details

Trial ID

NCT05239767

Start Date

June 1 2022

End Date

April 24 2023

Last Update

August 15 2023

Active Locations (1)

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Montefiore

The Bronx, New York, United States, 10467