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

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Acute Pain
• Intervention / Treatment: Drug: NSAID

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Benjamin W Friedman, MD; Phone Number: 718-920-6626; Email: befriedm@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketorolac; Ketorolac 20mg orally x 1	Drug: NSAID; We will administer oral NSAIDs
Active Comparator: Ibuprofen; Ibuprofen 800mg orally x 1	Drug: NSAID; We will administer oral NSAIDs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin W Friedman, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Acute Pain; Musculoskeletal Pain
• Other Study ID Numbers: 2022-13802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No