A Randomized Trial of NSAID Dosing Strategies

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05239767
Collaborator
(none)
400
1
2
22
18.2

Study Details

Study Description

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 investigators will also determine whether taking acetaminophen prior to the NSAID impacts efficacy

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
NSAID will be masked. Acetaminophen or no acetaminophen will not
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of NSAID Dosing Strategies
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Failure to achieve a minimum clinically important difference [Two hours]

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

Secondary Outcome Measures

  1. 0-10 pain score [One and two hours after medication administration]

    Improvement on 0-10 pain

  2. Ordinal pain scale [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 [Two hours after medication administration]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montefiore Bronx New York United States 10467

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT05239767
Other Study ID Numbers:
  • 2022-13802
First Posted:
Feb 15, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022