A Randomized Trial of NSAID Dosing Strategies

Acute Pain Clinical Trial

Official title:

A Randomized Trial of NSAID Dosing Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239767
• Other study ID #: 2022-13802
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: August 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Musculoskeletal Pain

Intervention

Drug:
• NSAID
We will administer oral NSAIDs

Locations

Country	Name	City	State
United States	Montefiore	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-10 pain score	Improvement on 0-10 pain	One and two hours after medication administration
Secondary	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
Secondary	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