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Completed

NCT Number: NCT05239767

A Randomized Trial of NSAID Dosing Strategies

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

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Key information

Conditions

Musculoskeletal Pain Acute Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NSAID

Drug

We will administer oral NSAIDs

Primary outcomes

  1. Failure to achieve a minimum clinically important difference

    Time frame: Two hours

    Failure to improve by at least 1.3 points on a 0-10 pain scale

Secondary outcomes

  1. 0-10 pain score

    Time frame: One and two hours after medication administration

    Improvement on 0-10 pain

  2. Ordinal pain scale

    Time frame: 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"

  3. Epigastric pain

    Time frame: Two hours after medication administration

    Participants will be asked if the medication caused "stomach pain". Response options are "no", "a little", "a lot"

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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