Back to resultsA Randomized Trial of NSAID Dosing Strategies
Primary Purpose
Musculoskeletal Pain, Acute Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NSAID
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
Eligibility Criteria
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
Sites / Locations
- Montefiore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ketorolac
Ibuprofen
Arm Description
Ketorolac 20mg orally x 1
Ibuprofen 800mg orally x 1
Outcomes
Primary Outcome Measures
Failure to achieve a minimum clinically important difference
Failure to improve by at least 1.3 points on a 0-10 pain scale
Secondary Outcome Measures
0-10 pain score
Improvement on 0-10 pain
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"
Epigastric pain
Participants will be asked if the medication caused "stomach pain". Response options are "no", "a little", "a lot"
Full Information
NCT ID
NCT05239767
First Posted
February 4, 2022
Last Updated
August 11, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05239767
Brief Title
A Randomized Trial of NSAID Dosing Strategies
Official Title
A Randomized Trial of NSAID Dosing Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
April 24, 2023 (Actual)
Study Completion Date
April 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
NSAID will be masked. Acetaminophen or no acetaminophen will not
Allocation
Randomized
Enrollment
407 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Ketorolac 20mg orally x 1
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 800mg orally x 1
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
We will administer oral NSAIDs
Primary Outcome Measure Information:
Title
Failure to achieve a minimum clinically important difference
Description
Failure to improve by at least 1.3 points on a 0-10 pain scale
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
0-10 pain score
Description
Improvement on 0-10 pain
Time Frame
One and two hours after medication administration
Title
Ordinal pain scale
Description
The investigators will determine the frequency of obtaining pain levels of "mild" and "none" on a scale of "severe", "moderate', "mild", or "none"
Time Frame
One and two hours after medication administration
Title
Epigastric pain
Description
Participants will be asked if the medication caused "stomach pain". Response options are "no", "a little", "a lot"
Time Frame
Two hours after medication administration
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Trial of NSAID Dosing Strategies
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